testosterone profile

ID Source	ID
PubMed CID	5408
CHEMBL ID	386630
CHEMBL ID	268313
CHEBI ID	94444
SCHEMBL ID	616350
MeSH ID	M0021196

Synonym
EU-0070267
androst-4-en-3-one, 17-hydroxy-, (17.beta.)-
oreton f
17.beta.-hydroxyandrost-4-en-3-one
17-hydroxy-(17.beta.)-androst-4-en-3-one
androst-4-en-17.beta.-ol-3-one
17.beta.-hydroxy-4-androsten-3-one
androst-4-en-3-one, 17.beta.-hydroxy-
.delta.4-androsten-17.beta.-ol-3-one
nsc9700
.delta.(4)-androsten-17.beta.-ol-3-one
.delta.(sup4)-androsten-17(.beta.)-ol-3-one
wln: l e5 b666 ov mutj a1 e1 fq
virormone
17.beta.-hydroxy-.delta.(sup4)-androsten-3-one
OPREA1_852285
nsc523833
9.beta.,10.alpha.-testosterone
nsc-523833
9-beta-10-alpha-testosterone
smr000109709
MLS000113817
STK013235
17-hydroxyandrost-4-en-3-one
AKOS000490915
17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one
(testosterone)17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-cyclopenta[a]phenanthren-3-one
17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-cyclopenta[a]phenanthren-3-one(testosterone)
chembl386630 ,
bdbm50025452
17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-cyclopenta[a]phenanthren-3-one (testosterone)
17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-cyclopenta[a]phenanthren-3-one
14-hydroxy-2,15-dimethyltetracyclo[8.7.0.02,7.011,15]heptadec-6-en-5-one
cpd000109709
HMS3259H09
CHEMBL268313
HMS2268M04
FT-0674873
F0452-4293
17-hydroxy-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-3(2h)-one
1221910-14-0
AB00437985-08
SCHEMBL616350
NC00634
BBL028526
AKOS016037980
MUMGGOZAMZWBJJ-UHFFFAOYSA-N
cambridge id 7215855
4-androsten-17a-ol-3-one-2,2,4,6,6-d5
VU0122138-8
CHEBI:94444
testosterone- 16,16,17-d3
Q27166309
VS-08816
1-hydroxy-9a,11a-dimethyl-1h,2h,3h,3ah,3bh,4h,5h,7h,8h,9h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one
17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3h-cyclopenta[a]phenanthren-3-one
(9beta,10alpha)-17beta-hydroxyandrost-4-en-3-one

Role	Description
androgen	A sex hormone that stimulates or controls the development and maintenance of masculine characteristics in vertebrates by binding to androgen receptors.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Class	Description
3-hydroxy steroid	Any hydroxy steroid carrying a hydroxy group at position 3.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein	Taxonomy	Measurement	Average (µ)	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Chain A, HADH2 protein	Homo sapiens (human)	Potency	25.1189	0.0251	20.2376	39.8107	AID886; AID893
Chain B, HADH2 protein	Homo sapiens (human)	Potency	25.1189	0.0251	20.2376	39.8107	AID886; AID893
TDP1 protein	Homo sapiens (human)	Potency	23.1093	0.0008	11.3822	44.6684	AID686979
glucocerebrosidase	Homo sapiens (human)	Potency	31.6228	0.0126	8.1569	44.6684	AID2101
chromobox protein homolog 1	Homo sapiens (human)	Potency	100.0000	0.0060	26.1688	89.1251	AID540317
parathyroid hormone/parathyroid hormone-related peptide receptor precursor	Homo sapiens (human)	Potency	31.6228	3.5481	19.5427	44.6684	AID743266
DNA polymerase iota isoform a (long)	Homo sapiens (human)	Potency	0.7079	0.0501	27.0736	89.1251	AID588590
Guanine nucleotide-binding protein G	Homo sapiens (human)	Potency	3.9811	1.9953	25.5327	50.1187	AID624287
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
negative regulation of inflammatory response to antigenic stimulus	Guanine nucleotide-binding protein G	Homo sapiens (human)
renal water homeostasis	Guanine nucleotide-binding protein G	Homo sapiens (human)
G protein-coupled receptor signaling pathway	Guanine nucleotide-binding protein G	Homo sapiens (human)
regulation of insulin secretion	Guanine nucleotide-binding protein G	Homo sapiens (human)
cellular response to glucagon stimulus	Guanine nucleotide-binding protein G	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
G protein activity	Guanine nucleotide-binding protein G	Homo sapiens (human)
adenylate cyclase activator activity	Guanine nucleotide-binding protein G	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
plasma membrane	Guanine nucleotide-binding protein G	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Assay ID	Title	Year	Journal	Article
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635	Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810	Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812	Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1745845	Primary qHTS for Inhibitors of ATXN expression
AID1794808	Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).	2014	Journal of biomolecular screening, Jul, Volume: 19, Issue:6	A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808	Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
AID1159607	Screen for inhibitors of RMI FANCM (MM2) intereaction	2016	Journal of biomolecular screening, Jul, Volume: 21, Issue:6	A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1159537	qHTS screening for TAG (triacylglycerol) accumulators in algae	2017	Plant physiology, Aug, Volume: 174, Issue:4	Identification and Metabolite Profiling of Chemical Activators of Lipid Accumulation in Green Algae.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (11.11)	29.6817
2010's	6 (66.67)	24.3611
2020's	2 (22.22)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	0 (0.00%)	5.53%
Reviews	0 (0.00%)	6.00%
Case Studies	0 (0.00%)	4.05%
Observational	0 (0.00%)	0.25%
Other	9 (100.00%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (458)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 1, Open-label, Randomized, Three-cohort, Two-period Crossover Study to Determine the Relative Bioavailability of Testosterone Following Application of Two Testosterone Transdermal Spray (TTS) Formulations Once Daily and Intrinsa® Patch Twice Weekl [NCT01096329]	Phase 1	16 participants (Actual)	Interventional	2010-02-28	Terminated
Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone [NCT03484260]		27,778 participants (Actual)	Observational	2018-04-01	Completed
A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men [NCT00702650]	Phase 3	155 participants (Actual)	Interventional	2008-06-30	Completed
Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study [NCT01092858]	Phase 4	4 participants (Actual)	Interventional	2010-09-30	Terminated
A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair [NCT04345666]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2021-08-31	Withdrawn(stopped due to Unable to obtain funding to complete the study)
Square Wave Testosterone Therapy in Castration Resistant Prostate Cancer [NCT03734653]	Early Phase 1	30 participants (Actual)	Interventional	2019-01-18	Active, not recruiting
Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer. [NCT01122342]	Phase 1/Phase 2	30 participants (Anticipated)	Interventional	2006-12-31	Suspended(stopped due to Evaluating outcomes of current subjects pre further enrollment/dose reduction.)
Testosterone Replacement in Metabolic Syndrome and Inflammation of Fat Tissue [NCT01123278]	Phase 4	82 participants (Actual)	Interventional	2004-01-31	Completed
An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier [NCT01130298]	Phase 1	24 participants (Actual)	Interventional	2010-05-31	Completed
Influence of Male Hormones on Regional Fat Metabolism [NCT01160328]	Phase 1	39 participants (Actual)	Interventional	2010-06-30	Completed
Evaluation of Some-puberty Related Hormones Among Children and Adolescents With Chronic Kidney Diseases [NCT05835089]		50 participants (Anticipated)	Observational	2023-05-31	Not yet recruiting
Bipolar Androgen Therapy Plus Olaparib in Patient With Castration-Resistant Prostate Cancer [NCT03516812]	Phase 2	36 participants (Actual)	Interventional	2018-08-29	Active, not recruiting
Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients [NCT02990533]	Phase 1	80 participants (Actual)	Interventional	2016-09-30	Active, not recruiting
Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men [NCT03091348]	Phase 4	4 participants (Actual)	Interventional	2017-08-29	Completed
Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study. [NCT01291212]		104 participants (Actual)	Interventional	2011-01-31	Active, not recruiting
Androgen Treatment in Leydig Cell Proliferation [NCT01206270]	Phase 2/Phase 3	56 participants (Actual)	Interventional	2009-06-30	Completed
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM. [NCT01560546]	Phase 4	43 participants (Actual)	Interventional	2012-03-31	Completed
Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW [NCT03768258]		1,268 participants (Actual)	Observational	2008-03-31	Completed
Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD [NCT03674320]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2021-12-01	Withdrawn(stopped due to No Funding)
Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism. [NCT03619330]	Phase 4	30 participants (Actual)	Interventional	2014-12-31	Completed
A Comparison of Hair Cortisol and Testosterone Levels in Patients With Acute MI and Controls With and Without Chronic Cardiovascular Disease or Diabetes [NCT01144065]		180 participants (Actual)	Observational	2010-08-31	Completed
Clinical Evaluation of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception [NCT03452111]	Phase 2	420 participants (Actual)	Interventional	2018-10-25	Active, not recruiting
The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease [NCT02433730]	Phase 4	40 participants (Actual)	Interventional	2015-05-01	Completed
Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents [NCT02679274]	Early Phase 1	3 participants (Actual)	Interventional	2016-02-16	Terminated(stopped due to Lack of funding.)
Patient Satisfaction After Switching to Oral Testosterone Undecanoate in Men Currently on Testosterone Therapy [NCT04983940]	Phase 4	41 participants (Actual)	Interventional	2021-06-18	Completed
A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH) [NCT04134091]	Phase 2	56 participants (Actual)	Interventional	2019-08-27	Completed
Effects of Fast Acting Testosterone Nasal Spray on Anxiety [NCT02361190]		96 participants (Actual)	Interventional	2015-02-28	Completed
EndogenousTestosterone Response to a Testosterone Boosting Supplement [NCT02600650]		60 participants (Anticipated)	Interventional	2015-11-30	Not yet recruiting
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 [NCT03792321]	Phase 4	55 participants (Actual)	Interventional	2014-01-10	Completed
A 150-Day, Prospective, Phase 4, Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Testosterone Nasal Gel (Natesto™) [NCT02937740]	Phase 4	117 participants (Actual)	Interventional	2016-10-31	Completed
Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism [NCT02111434]	Phase 4	150 participants (Actual)	Interventional	2013-07-31	Completed
Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study [NCT06149065]		247 participants (Actual)	Observational [Patient Registry]	2021-06-05	Completed
DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study [NCT06075953]	Phase 2	400 participants (Anticipated)	Interventional	2023-11-30	Recruiting
Evaluation of Serum Adrenal Androgens Among Prepubertal and Pubertal Boys With Autism Spectrum Disorder [NCT05811507]		100 participants (Anticipated)	Observational	2023-04-30	Not yet recruiting
Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study [NCT05649605]		70 participants (Anticipated)	Interventional	2023-03-07	Recruiting
Phase 4 Study That Evaluates the Presence of Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism and Effects of Two Different Testosterone Replacement Regiments on These Parameters. [NCT02171390]	Phase 4	130 participants (Actual)	Interventional	2008-08-31	Completed
Assessment of Sexual Maturation in β-Thalassemia Major Patients Receiving Iron Chelation Therapy in Assiut University Hospital [NCT03847558]		100 participants (Anticipated)	Observational	2019-04-15	Not yet recruiting
Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism [NCT04798469]	Phase 2	150 participants (Anticipated)	Interventional	2022-01-10	Recruiting
The Influence of Testosterone on Experimental Pain Perception and Social Psychological Functioning [NCT05781685]	Early Phase 1	20 participants (Actual)	Interventional	2017-10-01	Completed
Prevalence of Hyperandrogenism in Young Women With Type 1 Diabetes and Study of the Underlying Pathophysiological Mechanisms [NCT04979377]		150 participants (Anticipated)	Observational	2020-03-09	Recruiting
Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris [NCT05783778]		200 participants (Anticipated)	Interventional	2023-06-01	Not yet recruiting
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency [NCT04301765]	Phase 2	230 participants (Anticipated)	Interventional	2021-01-12	Recruiting
Long-term Lifestyle Change in Obese Older Veterans [NCT03256292]		38 participants (Actual)	Observational	2017-08-21	Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women [NCT00657501]	Phase 3	575 participants (Actual)	Interventional	2008-03-31	Completed
Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT02445716]	Phase 2	70 participants (Anticipated)	Interventional	2015-10-31	Recruiting
[NCT02317263]	Phase 2	0 participants (Actual)	Interventional		Withdrawn(stopped due to NIH did not fund the study so it never started)
A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception [NCT00403793]	Phase 2	350 participants (Actual)	Interventional	2003-10-31	Completed
Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure [NCT01377103]		0 participants (Actual)	Interventional	2011-07-31	Withdrawn
Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension Compared to Male Cirrhosis Patients Without Hypotension [NCT05051293]		0 participants (Actual)	Observational	2021-08-22	Withdrawn(stopped due to Study will be changed from prospective to retrospective)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism [NCT00962637]	Phase 3	194 participants (Actual)	Interventional	2006-03-31	Completed
Diagnostic Relevance of Salivary Testosterone Concentrations After Exogene Low-dose Hormone Application as a Screening Method for in Doping Control. [NCT02134470]		12 participants (Anticipated)	Interventional	2014-04-30	Active, not recruiting
Testosterone Replacement Therapy in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males. [NCT02317640]	Phase 1/Phase 2	56 participants (Anticipated)	Interventional	2017-03-15	Recruiting
Effects of Moderately Increased Testosterone Concentration on Physical Performance and Behaviour in Healthy Women - a Double-blind, Randomized, Placebo-controlled Study [NCT03210558]	Phase 2	48 participants (Actual)	Interventional	2017-05-26	Completed
Mechanisms of Hormonal Control of Spermatogenesis in Man [NCT02147964]	Phase 2	0 participants (Actual)	Interventional	2019-06-30	Withdrawn(stopped due to No funding was obtained for this study.)
Feasibility Study of Post-hospitalization Interventions to Improve Physical Function [NCT02203656]	Phase 1	113 participants (Actual)	Interventional	2013-10-31	Completed
A Randomized Phase I Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer [NCT01187485]	Phase 1	15 participants (Actual)	Interventional	2004-06-30	Completed
A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women [NCT01235754]	Phase 3	626 participants (Actual)	Interventional	2010-10-31	Completed
Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study [NCT04731376]	Phase 1	100 participants (Anticipated)	Interventional	2021-01-25	Recruiting
Exploring the Role of Testosterone on Neurovascular Control in Humans [NCT04819204]		20 participants (Anticipated)	Interventional	2021-06-30	Not yet recruiting
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women [NCT00613002]	Phase 3	597 participants (Actual)	Interventional	2006-12-31	Completed
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer [NCT00588185]		300 participants (Anticipated)	Interventional	2003-02-28	Recruiting
Effects of Testosterone on Myocardial Repolarization in Patients With Hypogonadism With/Without Chronic Heat Failure (NYHA Class I-II) [NCT03126656]	Phase 4	123 participants (Actual)	Interventional	2016-09-30	Completed
Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism [NCT05541172]		27 participants (Anticipated)	Observational	2022-03-01	Recruiting
Effect of PROGRESSive Resistance Training, Protein Supplements and Testosterone in Older Frail Men With Testosterone Deficiency (PROGRESS Trial) [NCT02873559]	Phase 2/Phase 3	196 participants (Anticipated)	Interventional	2016-11-01	Recruiting
Prospective, Randomized, Open-label and Comparative Study to Determine the Pharmacokinetic Parameters of Vaginal Rings That Contain DHEA, Testosterone, or the Combination of Both Androgens, in Comparison With Oral Administration of DHEA and Transdermal Ad [NCT03967964]	Phase 1	46 participants (Actual)	Interventional	2015-11-20	Completed
A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hyp [NCT01133548]	Phase 1	62 participants (Actual)	Interventional	2010-05-31	Completed
Testosterone Regulation of the Natriuretic Peptide System [NCT02269072]		0 participants (Actual)	Interventional	2015-02-28	Withdrawn(stopped due to Lack of funding)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women [NCT00612742]	Phase 3	3,656 participants (Actual)	Interventional	2008-01-31	Completed
Phase IV Study to Investigate the Effect of Testosterone Treatment on Paraoxonase Level in Male Patients With Hypogonadotrophic Hypogonadism [NCT01107067]	Phase 4	32 participants (Actual)	Interventional	2008-06-30	Completed
Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer [NCT02297386]	Phase 1	3 participants (Actual)	Interventional	2014-11-30	Completed
Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome [NCT01160341]	Phase 4	312 participants (Actual)	Interventional	2009-08-31	Completed
Investigating the Efficacy of Subcutaneous Testosterone Compared to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents [NCT03864913]	Early Phase 1	26 participants (Anticipated)	Interventional	2018-01-26	Active, not recruiting
Prospective Randomized Controlled Trial of Antral Follicle Priming Prior to IVF-ICSI in Previously Diagnosed Low Responders. [NCT01310647]	Phase 2	66 participants (Actual)	Interventional	2011-06-30	Completed
A Phase IV, Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of 16 Weeks Treatment With Androderm® in Hypogonadal Men [NCT04320745]	Phase 4	168 participants (Actual)	Interventional	2020-05-19	Completed
Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue [NCT03379012]	Phase 2	60 participants (Actual)	Interventional	2016-02-08	Completed
Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application [NCT01228071]	Phase 3	34 participants (Actual)	Interventional	2010-11-30	Completed
Observational Study of Clinical Outcomes for Testosterone Treatment of Pubertal Delay in Duchenne Muscular Dystrophy [NCT02571205]		15 participants (Actual)	Observational	2015-11-30	Completed
Phase I Clinical Trial for Evaluation of Pharmacokinetics, Pharmacodynamics and Safety of Testosterone Gel 1% for Topical Use, After Administration of Three Different Doses (2.2 mg, 4.4 mg, 8.8 mg and Placebo) for 28 Consecutive Days in Post-menopausal Wo [NCT02667561]	Phase 1	0 participants (Actual)	Interventional	2017-07-31	Withdrawn(stopped due to Study has been cancelled and it has not been initiated.)
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome [NCT00351819]	Phase 2	84 participants (Actual)	Interventional	2006-04-30	Completed
[NCT02847806]	Phase 3	6 participants (Actual)	Interventional	2008-01-31	Completed
A Multicenter, Randomized, Double-Blind Comparator Trial of the Safety and Sperm and Gonadotropin Suppression Resulting From Combined Use of Nestorone® Gel (0, 8 or 12 mg NES) and Testosterone Gel (10 g) Compared With Testosterone Gel in Normal Men [NCT00891228]	Phase 1	99 participants (Actual)	Interventional	2009-05-31	Completed
Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers [NCT00080756]	Phase 2	11 participants (Actual)	Interventional	2004-03-11	Active, not recruiting
A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus [NCT00504712]	Phase 4	24 participants (Actual)	Interventional	2006-02-28	Completed
Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men [NCT03724825]		82 participants (Actual)	Observational	2018-12-01	Completed
Effect of Dose Fractionation of Testosterone Cypionate on Hematocrit in Transgender Men With Erythrocytosis Secondary to Testosterone Use. [NCT05487794]		40 participants (Anticipated)	Interventional	2022-09-01	Recruiting
A Single-Dose, Single Period, Phase II Pharmacokinetic Study To Examine Testagen™ TDS®-Testosterone For Its Potential To Be Inadvertently Transferred By Skin Contact After Dosing In Healthy Adult Subjects [NCT02733133]	Phase 2	96 participants (Anticipated)	Interventional	2016-11-30	Enrolling by invitation
Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study [NCT03339635]	Phase 2	40 participants (Anticipated)	Interventional	2018-12-21	Active, not recruiting
The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans With Spinal Cord Injury [NCT06130449]	Early Phase 1	15 participants (Anticipated)	Interventional	2024-04-01	Not yet recruiting
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? [NCT05964920]	Phase 2/Phase 3	40 participants (Anticipated)	Interventional	2024-01-01	Not yet recruiting
Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture [NCT02938923]	Phase 3	129 participants (Actual)	Interventional	2017-09-15	Completed
Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism [NCT02111473]	Phase 4	49 participants (Actual)	Interventional	2009-05-31	Completed
A Randomized, Parallel, Double-dummy, Multi-center Phase III Study for Evaluation of Efficacy and Safety of Nasotestt Compared to Androgel Treating Hypogonadism in Male Research Participants. [NCT03281187]	Phase 3	228 participants (Anticipated)	Interventional	2018-07-16	Not yet recruiting
Prospective Biomarker Analysis of Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Undergoing Bipolar Androgen Therapy (BAT) [NCT04424654]	Phase 2	20 participants (Actual)	Interventional	2020-09-22	Completed
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism [NCT03118479]	Phase 1	7 participants (Actual)	Interventional	2010-05-31	Terminated(stopped due to Because the PI left the institution.)
A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer [NCT06100705]	Phase 2	26 participants (Anticipated)	Interventional	2023-11-30	Not yet recruiting
A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer [NCT04363164]	Phase 2	150 participants (Anticipated)	Interventional	2020-08-19	Recruiting
T&T Trial: Adding Testosterone to Tamoxifen in Male Breast Cancer Patients [NCT05156606]		6 participants (Anticipated)	Interventional	2022-11-10	Recruiting
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men [NCT03868059]	Phase 3	138 participants (Actual)	Interventional	2018-04-30	Completed
China Gender-affirming Hormone Therapy Study in Transgender Men and Women [NCT05318755]		240 participants (Anticipated)	Observational	2022-04-16	Recruiting
Phase IV: Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism [NCT01084369]	Phase 4	22 participants (Actual)	Interventional	2013-10-11	Terminated(stopped due to Withdrawal of sponsorship)
Investigator Initiated Study of the Effects of Androgen Therapy on Carbohydrate and Lipid Metabolism In Elderly Men [NCT00365794]	Phase 2	22 participants (Actual)	Interventional	2006-08-31	Completed
A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder. [NCT00467259]	Phase 3	1,271 participants (Actual)	Interventional	2007-04-30	Completed
Testosterone Replacement Therapy in Chronic Spinal Cord Injury [NCT00266864]	Phase 2/Phase 3	31 participants (Actual)	Interventional	2003-08-31	Completed
A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men [NCT00433199]	Phase 3	274 participants (Actual)	Interventional	2007-02-28	Completed
Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men [NCT00799617]	Phase 3	790 participants (Actual)	Interventional	2009-11-30	Completed
Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels [NCT00613782]	Phase 2/Phase 3	88 participants (Actual)	Interventional	2009-01-31	Completed
52 Week RCT to Investigate the Effect of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese/Overweight Men With T2DM/Prediabetes and Hypogonadism and Subsequent 108 Week Open Label Phase to Investigate Effects on Cardiometabolic Para [NCT03851627]	Phase 4	32 participants (Anticipated)	Interventional	2022-01-25	Recruiting
Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients [NCT02712944]	Phase 1	21 participants (Actual)	Interventional	2016-07-31	Terminated(stopped due to Study stopped for procedural difficulties and lack of personnel)
A Multiple Dose, Pharmacokinetic Study Comparing Different Regimens of Testosterone Given as Intranasal NASOBOL® in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers [NCT00647868]	Phase 1	32 participants (Actual)	Interventional	2008-05-31	Completed
Repeat Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Asymptomatic Patients With Metastatic Castration-Resistant Prostate Cancer: The APEX (Androgen and Polyamine Elimination Alternating With Xtandi) Trial [NCT06059118]	Phase 2	50 participants (Anticipated)	Interventional	2023-10-04	Recruiting
Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo [NCT04807894]	Phase 4	100 participants (Anticipated)	Interventional	2020-11-01	Recruiting
Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism [NCT03887936]	Phase 4	166 participants (Anticipated)	Interventional	2019-10-01	Recruiting
Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction. [NCT02803073]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2016-08-31	Withdrawn(stopped due to Subjects could not be recruited)
Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor [NCT05484167]	Phase 4	0 participants (Actual)	Interventional	2023-01-01	Withdrawn(stopped due to They study lost funding and decided to close the study down.)
A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women [NCT00969163]	Phase 1	30 participants (Actual)	Interventional	2004-10-31	Completed
Testosterone Supplementation in Men With MCI [NCT00539305]	Phase 3	22 participants (Actual)	Interventional	2009-07-31	Completed
Phase II Trial of Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer [NCT00853697]	Phase 2	6 participants (Actual)	Interventional	2009-03-31	Completed
Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use [NCT04895306]	Phase 2	40 participants (Anticipated)	Interventional	2022-04-30	Recruiting
Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5) [NCT00161447]	Phase 1/Phase 2	43 participants (Actual)	Interventional	2004-05-31	Completed
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study. [NCT00398034]	Phase 2	0 participants (Actual)	Interventional	2006-10-30	Withdrawn(stopped due to The original PI (David Siegel) Left the VA)
A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer [NCT00515112]	Phase 2	6 participants (Actual)	Interventional	2007-07-31	Terminated(stopped due to This study has been terminated due to poor accrual)
A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men [NCT01017458]	Phase 1	68 participants (Actual)	Interventional	2007-06-30	Completed
An Open-Label Study to Evaluate the Safety of Testosterone Enanthate After Two Single-Dose Injections Via QuickShot® Testosterone by Intended Users and QuickShot™ Summative Usability Study [NCT02777242]	Phase 2	66 participants (Actual)	Interventional	2016-06-30	Completed
Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men [NCT00695110]	Phase 2	29 participants (Actual)	Interventional	2008-06-30	Completed
The Effect of Male Hormonal Contraceptive Regimens on Prostate Tissue In Normal Men [NCT00490555]	Phase 2/Phase 3	32 participants (Actual)	Interventional	2009-01-31	Completed
A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy [NCT05862519]		36 participants (Actual)	Interventional	2023-03-14	Active, not recruiting
Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial [NCT03995251]		100 participants (Anticipated)	Interventional	2019-07-04	Recruiting
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle [NCT00586898]	Phase 2	36 participants (Actual)	Interventional	2001-07-31	Completed
A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR) [NCT00816712]	Phase 1	28 participants (Actual)	Interventional	2008-01-31	Completed
Compromised Microcirculation in Women With Polycystic Ovary Syndrome [NCT00757185]	Early Phase 1	28 participants (Actual)	Interventional	2008-02-29	Completed
Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome [NCT00487734]	Phase 4	19 participants (Actual)	Interventional	2007-08-31	Completed
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [NCT00957801]	Phase 4	29 participants (Actual)	Interventional	2009-03-31	Completed
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy [NCT04833426]	Phase 3	140 participants (Anticipated)	Interventional	2022-12-12	Recruiting
Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill: a Randomised Double Blind Clinical Trial [NCT05825092]	Phase 2	600 participants (Anticipated)	Interventional	2023-07-21	Recruiting
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer [NCT06145399]	Early Phase 1	10 participants (Anticipated)	Interventional	2023-10-24	Recruiting
Nutrition and Anabolic Interventions in Squamous Cell Carcinoma [NCT00878995]	Phase 1	28 participants (Actual)	Interventional	2009-06-03	Completed
An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men [NCT01104246]	Phase 1	40 participants (Actual)	Interventional	2010-04-30	Completed
Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01) [NCT00848497]	Early Phase 1	3 participants (Actual)	Interventional	2007-11-30	Terminated(stopped due to Lack of volunteers who would consent to participate and lack of funding)
Effects of Sex Steroid Hormones on Serotonin Synthesis and Degradation Measured With PET [NCT02715232]	Phase 4	92 participants (Anticipated)	Interventional	2017-02-06	Recruiting
Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism [NCT00613288]		12 participants (Anticipated)	Interventional	2007-09-30	Completed
High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer [NCT03522064]	Phase 2	30 participants (Anticipated)	Interventional	2018-07-30	Recruiting
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men [NCT02081300]	Phase 3	315 participants (Actual)	Interventional	2014-02-28	Completed
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203 [NCT01386567]	Phase 2	48 participants (Actual)	Interventional	2011-07-31	Completed
Metabolic Effects of Testosterone Alone or in Combination With Dutasteride or Anastrazole in Obese Men [NCT00983554]		57 participants (Actual)	Interventional	2005-06-30	Active, not recruiting
Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men [NCT04134130]		33 participants (Actual)	Interventional	2019-09-16	Completed
The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men [NCT00700024]	Phase 4	60 participants (Anticipated)	Interventional	2008-04-30	Active, not recruiting
An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to Assess Bioequivalence of the 300 Mcg/Day Testosterone Reduced-size Patch (14 cm2) Relative to the 300 Mcg/Day Testosterone Reference Patch (28 cm2) [NCT00791856]	Phase 1	110 participants (Actual)	Interventional	2007-07-31	Completed
COMbination of Bipolar Androgen Therapy and Nivolumab in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03554317]	Phase 2	53 participants (Actual)	Interventional	2018-09-05	Completed
Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men Title Changed With New Protocol (12/14/09): Hormonal Regulation of HDL-C in Men [NCT00729859]	Phase 2	31 participants (Actual)	Interventional	2008-12-31	Completed
Exploring the Relationship Between Androgen Metabolism, Metabolic Disease and Skeletal Muscle Energy Balance in Men [NCT05773183]		60 participants (Anticipated)	Observational	2023-03-12	Not yet recruiting
A Single-Center, Double-Masked, Randomized, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Testosterone 0.03% Ophthalmic Solution Compared to Vehicle for the Treatment of Meibomian Gland Dysfunction [NCT00755183]	Phase 2	60 participants (Actual)	Interventional	2008-07-31	Completed
Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy [NCT01921374]		60 participants (Actual)	Interventional	2013-08-31	Completed
[NCT00006129]		60 participants	Interventional	2000-06-30	Recruiting
[NCT00000175]		0 participants	Interventional		Terminated
Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer [NCT04049331]	Phase 2	240 participants (Anticipated)	Interventional	2021-03-22	Recruiting
A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism [NCT00812396]	Phase 1	30 participants (Actual)	Interventional	2007-11-30	Completed
Male Hormonal Contraception Development: Suppression of Spermatogenesis With the Addition of a Potent GnRH Antagonist (Acyline) to Testosterone and DMPA (ACY-5) -Sub-Study (HOP 5) [NCT00156650]	Phase 1/Phase 2	23 participants (Actual)	Interventional	2004-12-31	Completed
Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR) [NCT00425568]		30 participants	Observational	2005-12-31	Completed
An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% [NCT00998933]	Phase 1	24 participants (Actual)	Interventional	2009-10-31	Completed
A Two-Arm, Open-Label, Randomized, Multi-Center Pharmacokinetic and Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men [NCT00467870]	Phase 3	531 participants (Actual)	Interventional	2006-03-31	Completed
The Cardiac Benefit of Androgen Replacement in Hypogonadal Males With Coronary Artery Disease Following Successful Percutaneous Coronary Intervention (PCI). [NCT00413244]	Phase 3	51 participants (Actual)	Interventional	2007-01-31	Completed
Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial [NCT02549690]		0 participants (Actual)	Interventional	2015-09-30	Withdrawn
Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease [NCT00239590]	Phase 2	28 participants (Actual)	Interventional	2001-06-30	Completed
A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes [NCT03973840]	Phase 1	13 participants (Actual)	Interventional	2018-07-15	Completed
An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males [NCT00522431]	Phase 3	149 participants (Actual)	Interventional	2007-08-31	Completed
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections: A Phase IV, Prospective, Randomized, Non-Blinded, Multi-Institutional Study [NCT04439799]	Phase 4	81 participants (Actual)	Interventional	2020-08-07	Completed
The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men [NCT00104572]	Phase 2	44 participants (Actual)	Interventional	2004-03-31	Completed
Androgen Effects in HIV-infected Women [NCT00095212]		25 participants (Actual)	Interventional	2004-09-30	Completed
Effects of Testosterone Replacement on Atherosclerosis Progression in Older Men With Low Testosterone Levels [NCT00287586]	Phase 4	308 participants (Actual)	Interventional	2004-09-30	Completed
A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism [NCT00193661]	Phase 2	0 participants	Interventional	2002-08-31	Completed
Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age [NCT00193700]	Phase 1	0 participants	Interventional	2002-08-31	Completed
Pilot Open Study of Testosterone Replacement in Non-alcoholic Steatohepatitis [NCT01919294]	Phase 2	3 participants (Actual)	Interventional	2013-07-31	Completed
Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance [NCT00204269]	Phase 3	100 participants	Interventional	2003-01-31	Active, not recruiting
Androgen Regulation of Priapism in Sickle Cell Disease [NCT01940718]	Early Phase 1	0 participants (Actual)	Interventional	2014-03-31	Withdrawn(stopped due to Funding could not be secured)
Clinical Trial of Androgen Effects on the Reproductive Neuroendocrine Axis [NCT04321551]	Phase 4	40 participants (Anticipated)	Interventional	2023-07-01	Not yet recruiting
Clinical Role of Testosterone and Dihydrotestosterone and Which of Them Should be Inhibited in COVID-19 Patients - A Double-edged Sword? [NCT04623385]	Phase 4	1,000 participants (Anticipated)	Interventional	2020-11-30	Not yet recruiting
The Effect of Transdermal Testosterone Pretreatment in Poor Responders Undergoing Ovarian Stimulation for In-vitro Fertilization (IVF) [NCT01961336]	Phase 3	50 participants (Actual)	Interventional	2013-10-31	Completed
A Pilot Study in Healthy Male Volunteers to Evaluate a Skeletal-Muscle Microbiopsy Technique for Suitability of Use With Dynamic Proteomic Measurement [NCT01962454]	Phase 1	20 participants (Actual)	Interventional	2014-05-05	Completed
Testosterone Therapy and Its Effects on Metabolic Function [NCT01963390]		60 participants (Actual)	Observational	2012-07-31	Completed
[NCT01993212]	Phase 3	120 participants (Actual)	Interventional	2014-01-31	Completed
[NCT01993225]	Phase 3	120 participants (Actual)	Interventional	2014-01-31	Completed
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening [NCT04675788]	Phase 4	83 participants (Anticipated)	Interventional	2021-09-02	Recruiting
A Preliminary Trial of Testosterone Replacement for Fatigue in Male Hypogonadic Patients With Advanced Cancer. [NCT00965341]	Phase 3	53 participants (Actual)	Interventional	2009-09-30	Completed
Testosterone Replacement Therapy in Castration-Resistant Prostate Cancer [NCT00577980]	Phase 2	0 participants (Actual)	Interventional	2007-12-31	Withdrawn(stopped due to Zero accrual and failure to generate multicenter interest.)
Therapeutic Effect of Prolonged Testosterone Pretreatment in Women With Poor Ovarian Response: a Randomized Control Trial [NCT04602143]		165 participants (Actual)	Interventional	2018-02-16	Completed
Testosterone Replacement and Dutasteride Effectiveness (TRADE) [NCT00194675]	Phase 4	53 participants (Actual)	Interventional	2005-03-31	Completed
Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women [NCT02215434]	Phase 2	60 participants (Actual)	Interventional	2009-09-30	Completed
A Randomized Double-blind Placebo-controlled Pilot Trial on the Effects of Testosterone Undecanoate Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolic Profile in Transmen [NCT04545450]	Phase 3	16 participants (Actual)	Interventional	2008-11-04	Completed
Testosterone and Alendronate in Hypogonadal Men [NCT01460654]	Phase 2	44 participants (Actual)	Interventional	2011-10-31	Terminated
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome [NCT01689896]	Phase 4	0 participants (Actual)	Interventional	2012-08-31	Withdrawn(stopped due to Difficult to obtain placebo)
Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience [NCT01601327]	Phase 4	119 participants (Actual)	Interventional	2008-01-31	Completed
Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia [NCT00838838]		26 participants (Actual)	Observational	2005-09-30	Completed
Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption: Evaluation of Newly Developed Markers [NCT04166786]	Phase 1	4 participants (Actual)	Interventional	2019-05-06	Completed
Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation [NCT00675714]	Phase 2/Phase 3	1,126 participants (Actual)	Interventional	2004-01-31	Terminated(stopped due to At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.)
Transdermal Testosterone to Improve Ovarian Response to Gonadotropins in Poor Responder IVF Patients With Normal Basal Concentrations of FSH [NCT00693108]	Phase 3	0 participants	Interventional	2006-09-30	Completed
A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing. [NCT00996151]	Phase 1	10 participants (Actual)	Interventional	2009-12-31	Completed
Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; A Prospective Non Randomised Open Label Multicenter Phase Two Study in Male Longterm Survivors of Malignant Lymphoma (Vitality) [NCT04492553]	Phase 2	7 participants (Actual)	Interventional	2021-04-01	Completed
Androgen Modulation of Response to Selective Phosphodiesterase Inhibitors in Erectile Dysfunction [NCT00512707]	Phase 4	140 participants (Actual)	Interventional	2006-11-30	Completed
A Phase III Open-label Extension of the MTE08 Trial (A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men) to Evaluate [NCT00857454]	Phase 3	71 participants (Actual)	Interventional	2008-10-31	Completed
Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes [NCT02513940]	Phase 4	14 participants (Actual)	Interventional	2016-05-31	Completed
Effect of Hypogonadotrophic Hypogonadism and Treatment With Testosterone on Insulin Sensitivity, Inflammation, Body Composition and Sexual Function in Obese and Type 2 Diabetic Men [NCT01127659]	Phase 4	137 participants (Actual)	Interventional	2010-05-31	Completed
A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients [NCT01516554]	Phase 2	3 participants (Actual)	Interventional	2012-02-29	Terminated(stopped due to Poor recruitment)
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease [NCT00645658]		17 participants (Actual)	Interventional	2007-08-31	Completed
Use of Perioperative Testosterone Replacement Therapy (TRT) in Sarcopenic Male Colorectal Cancer Patients - A Single Arm Open Label Feasibility Study [NCT05367284]		30 participants (Anticipated)	Observational	2022-01-15	Recruiting
The Effects of Cyclic Testosterone Administration on Muscle Function in Older Individuals [NCT00957528]	Phase 1	26 participants (Actual)	Interventional	2006-01-31	Completed
Sex Steroids, Sleep, and Metabolic Dysfunction in Women [NCT00805207]		61 participants (Actual)	Interventional	2007-09-30	Completed
A Placebo-controlled Study to Determine the Efficacy and Safety of 300 and 450 µg/Day Transdermal Testosterone in Female Patients With Low Ejection Fraction and Symptomatic Heart Failure [NCT00957034]	Phase 2	17 participants (Actual)	Interventional	2009-07-31	Terminated(stopped due to Due to difficult patient enrollment.)
A Multinomial Process Model of Moral Judgment [NCT02799277]	Phase 4	220 participants (Actual)	Interventional	2017-08-30	Completed
Growth Hormone and Gonadotropin Deficiency After Brain Injury (Traumatic Brain Injury, Subarachnoidal Hemorrhage, Ischemic Stroke): the Effects of Hormone Replacement on Cognition, Quality of Life and Body Composition [NCT01397500]	Phase 2	54 participants (Actual)	Interventional	2011-11-30	Terminated(stopped due to Recruitment problems due to change of patient population at site.)
Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance [NCT01408498]		120 participants (Actual)	Interventional	2012-01-31	Completed
Study to Evaluate the Efficacy and Safety of Transdermal Testosterone in Women With Hypoactive Sexual Desire Disorder on Concurrent Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy [NCT00331214]	Phase 3	533 participants (Actual)	Interventional	2002-06-30	Completed
The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men [NCT01417364]	Phase 4	0 participants (Actual)	Interventional	2016-01-31	Withdrawn(stopped due to Unable to identify any qualifying subjects willing to enroll into this study.)
Prospective Two-arm Study of Fertility in Men With COVID-19 [NCT04716179]		88 participants (Anticipated)	Interventional	2021-01-18	Recruiting
The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1) [NCT00161486]	Phase 1	13 participants (Actual)	Interventional	2004-07-31	Completed
[NCT01432665]	Phase 2	196 participants (Actual)	Interventional	2011-09-30	Completed
A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer [NCT00006044]	Phase 1	0 participants	Interventional	2000-02-29	Completed
[NCT00006158]	Phase 2	0 participants	Interventional	1998-09-30	Completed
The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa [NCT00853502]	Phase 2	0 participants (Actual)	Interventional	2008-12-31	Withdrawn(stopped due to No recruitment)
A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution) [NCT00857168]	Phase 1	36 participants (Anticipated)	Interventional	2009-01-31	Completed
A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men [NCT00696748]	Phase 3	250 participants (Anticipated)	Interventional	2005-10-31	Recruiting
Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application [NCT00705796]	Phase 1	0 participants (Actual)	Interventional		Withdrawn(stopped due to financial constraints)
Locomotor Training With Testosterone to Promote Bone and Muscle Health [NCT04460872]	Phase 2	21 participants (Anticipated)	Interventional	2021-01-31	Recruiting
Salivary Testosterone in Men: Diurnal Variation and Post-prandial Responses [NCT04326673]		40 participants (Actual)	Observational	2020-10-30	Active, not recruiting
Study of Testosterone and rHGH in FSHD (STARFISH): A Proof-of-Concept Study [NCT03123913]	Phase 1	20 participants (Actual)	Interventional	2017-12-18	Completed
Exercise Training and Testosterone Replacement in Heart Failure Patients [NCT01852994]	Phase 4	39 participants (Actual)	Interventional	2009-07-31	Completed
Impact of Estradiol Addback on Somatostatin Rebound in Older Men [NCT01862835]	Phase 1	43 participants (Actual)	Interventional	2013-05-31	Completed
The Effects of Natesto For Treatment Of Hypogonadism On Maintenance Of Spermatogensis. [NCT04717362]	Early Phase 1	40 participants (Anticipated)	Interventional	2024-03-01	Not yet recruiting
Phase II Trial of Targeted Radiation With no Castration for Mcrpc [NCT06084338]	Phase 2	60 participants (Anticipated)	Interventional	2023-11-13	Not yet recruiting
An Open-Label, Randomized, Balanced, Single-Dose, Two Treatment, Four Period, Two Sequence Replicate Design, Bioequivalence Study Of Testosterone Topical Gel, 1.62% Metered Pump, Manufactured By Amneal Pharmaceuticals LLC With AndroGel (Testosterone Gel) [NCT02110368]	Phase 3	32 participants (Actual)	Interventional	2014-03-31	Completed
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV. [NCT00555087]	Phase 4	50 participants (Anticipated)	Interventional	2007-05-31	Recruiting
A Phase II, Randomised, Four-way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered Dose (MD) Lotion® Formulations and Doses in Hypogonadal Men [NCT00857961]	Phase 2	21 participants (Actual)	Interventional	2007-10-31	Completed
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women [NCT01724658]	Phase 2	70 participants (Actual)	Interventional	2012-06-30	Completed
A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 52 Weeks and Safety for 52 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy. [NCT00338312]	Phase 3	610 participants (Actual)	Interventional	2002-06-30	Completed
Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men [NCT00452322]	Phase 2	60 participants	Interventional	1997-04-30	Completed
Phase IV Study of The Therapy of Long-acting Testosterone Undecanoate,1000mg in 4 ml Oily Solution for i.m.Injection(Nebido) as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction [NCT00421460]	Phase 4	30 participants (Actual)	Interventional	2007-01-31	Completed
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome [NCT00438321]	Phase 1	66 participants (Actual)	Interventional	2006-09-30	Terminated(stopped due to PI relocated)
Kallmann Syndrome in Finland [NCT00623116]		50 participants (Anticipated)	Interventional	2007-12-31	Enrolling by invitation
Testosterone Dose Response in Surgically Menopausal Women [NCT00494208]		270 participants (Actual)	Interventional	2009-01-31	Completed
A Randomised Placebo Controlled Study of Transdermal Testosterone Therapy to Investigate the Efficacy and Safety in Men With Abdominal Obesity, Low Testosterone Levels and Early Stages of the Metabolic Cluster Syndrome. [NCT00479609]	Phase 3	176 participants (Anticipated)	Interventional	2007-04-30	Recruiting
A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye [NCT06154200]	Phase 2	24 participants (Anticipated)	Interventional	2023-04-02	Recruiting
Long-Acting Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure [NCT00512408]		0 participants	Observational	2006-07-31	Terminated
A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine TDS-Testosterone 5% in Adult Male Subjects [NCT01894308]	Phase 2	48 participants (Anticipated)	Interventional	2024-06-30	Not yet recruiting
Generation of Biological Samples Positive to Testosterone for Anti-doping Control [NCT04207684]	Phase 1	4 participants (Actual)	Interventional	2020-02-04	Completed
Pilot Study: Evaluating the Effect of 300 Micrograms Testosterone Patches in Addition to Hormone Replacement Therapy on Arterial Compliance, Insulin Resistance and Sexual Desire. [NCT01208038]	Phase 4	22 participants (Actual)	Interventional	2011-03-31	Completed
Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (Short Title (HOP-3) [NCT00839319]	Phase 1/Phase 2	59 participants (Actual)	Interventional	2009-03-31	Completed
[NCT00004344]		4 participants	Observational	1997-01-31	Completed
Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease [NCT05249634]	Phase 2	20 participants (Anticipated)	Interventional	2022-03-15	Recruiting
Transdermal Testosterone Gel for Poor Ovarian Responders. A Multicenter Double-blind Placebo Controlled Randomized Trial [NCT02418572]	Phase 3	400 participants (Anticipated)	Interventional	2015-04-30	Recruiting
The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study [NCT00075855]	Phase 3	150 participants (Actual)	Interventional	2004-04-30	Completed
The Role of 5-Alpha Reductase in Mediating Testosterone Actions [NCT00070733]	Phase 3	184 participants	Interventional	2003-08-31	Recruiting
Testosterone and Physical Function in HIV Associate Weight Loss [NCT00260143]	Phase 2	61 participants (Actual)	Interventional	2003-05-31	Completed
Testosterone Therapy After Hip Fracture in Elderly Women [NCT00280267]	Phase 2	15 participants (Actual)	Interventional	2004-08-31	Completed
An Open Label, Dose-Proportionality, Bioavailability and Dose- Titration Investigation of the Pharmacokinetics, Metabolism, Efficacy and Safety of Two Testosterone Matrix Transdermal Systems (28 cm2 and 48 cm2) in Hypogonadal Men [NCT01323140]	Phase 2	40 participants (Actual)	Interventional	2011-04-30	Completed
Does Testosterone Improve Function in Hypogonadal Older Men [NCT00304213]	Phase 4	0 participants (Actual)	Interventional	2006-03-31	Withdrawn(stopped due to Study never started, PI relocation)
High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency [NCT05011383]	Phase 2	51 participants (Anticipated)	Interventional	2021-08-31	Recruiting
An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components [NCT00400335]	Phase 1	60 participants (Actual)	Interventional	2006-10-31	Completed
Testosterone Replacement for Male Opioid Agonist Maintained Patients [NCT01873989]	Phase 1/Phase 2	15 participants (Actual)	Interventional	2012-04-30	Completed
Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy. [NCT00331123]	Phase 3	562 participants (Actual)	Interventional	2002-05-31	Completed
The Developmental Origins of Endometriosis [NCT05951452]		40 participants (Anticipated)	Observational	2023-10-01	Recruiting
Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men [NCT00431197]	Phase 1	40 participants (Anticipated)	Interventional	2004-02-29	Completed
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency [NCT00434824]	Phase 2	322 participants (Actual)	Interventional	2001-11-30	Completed
Effect of Androgel on Total and Regional Adipose Tissue and Lean Body Mass in Type 2 Diabetic Patients With Hypogonadism [NCT00440440]	Phase 4	0 participants (Actual)	Interventional	2009-08-31	Withdrawn(stopped due to study merged with another study)
The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly [NCT00117000]	Phase 3	200 participants	Interventional	2003-07-31	Active, not recruiting
[NCT00119483]		200 participants	Interventional	2005-09-30	Completed
The Role of 5-alpha Reductase in Mediating Testosterone Actions [NCT00493987]	Phase 4	184 participants (Anticipated)	Interventional	2002-11-30	Completed
Phase II Study of Testosterone Replacement in Women Experiencing Aromatase Inhibitor Side-Effects in Adjuvant Therapy for Breast Cancer [NCT00497458]	Phase 2	90 participants (Anticipated)	Interventional	2007-07-31	Active, not recruiting
Muscle Strength and -Mass After Bariatric Surgery - a Possible Effect of Testosterone Replacement Therapy? Randomized, Placebo-controlled and Double-blinded Study [NCT03721497]	Phase 4	50 participants (Anticipated)	Interventional	2020-12-17	Recruiting
A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy [NCT00131495]	Phase 3	814 participants (Actual)	Interventional	2004-07-31	Completed
A Double Blind, Randomized, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Androgel, as an Adjunct to Hypoglycemic Therapy, in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes [NCT00141492]	Phase 2	0 participants	Interventional	2004-10-31	Completed
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women [NCT00141570]	Phase 2	350 participants	Interventional	2004-06-30	Completed
Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men) [NCT00161304]	Phase 2/Phase 3	44 participants (Actual)	Interventional	2003-04-30	Completed
Oral Androgens in Man-3: Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title: ORAL T-3 [NCT00161421]	Phase 2	18 participants (Actual)	Interventional	2005-03-31	Completed
Transdermal Testosterone Gel Prn Application for Hypoactive Sexual Desire Disorder in Women: A Controlled Study [NCT00140153]	Phase 3	20 participants	Interventional	2005-04-30	Completed
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women [NCT00141557]	Phase 2	133 participants (Actual)	Interventional	2004-07-31	Terminated(stopped due to Lack of enrollment)
Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men. [NCT00911586]	Phase 2	15 participants (Actual)	Interventional	2009-07-31	Completed
Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men [NCT00924612]	Phase 2	16 participants (Actual)	Interventional	2009-07-31	Completed
Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatmen [NCT01454011]	Phase 4	140 participants (Actual)	Interventional	2008-09-30	Completed
Testosterone Effects on Bone and Frailty in Men With Osteoporosis [NCT00182871]	Phase 4	140 participants	Interventional	2001-11-30	Completed
Multicenter, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone 50-100mg) to Evaluate Its Efficacy and Safety in Men Presenting With Typical Symptoms of Partial Androgen Deficiency of Aging Males (PADAM) Over a Period of 6 Month [NCT00185198]	Phase 3	363 participants (Actual)	Interventional	2004-09-30	Completed
A Randomized, Open Label Clinical Trial to Evaluate if Nestorone Gel Has Gonadotropin Suppressive Activity and if Nestorone in Combination With Testosterone Will Have an Additive Effect on Gonadotropin Suppression When Applied Transdermally in Healthy Men [NCT00229593]	Phase 1	140 participants (Actual)	Interventional	2005-09-30	Completed
Double-Blind, Placebo Controlled Randomized Study of Co-Administering Testosterone With PDE5 Inhibitors in Patients Non-Responders to PDE5 Inhibitors Alone [NCT00244023]	Phase 3	173 participants (Actual)	Interventional	2005-10-31	Completed
Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics [NCT00220298]	Phase 3	96 participants (Actual)	Interventional	2003-02-28	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two Period Cross Over Trial to Validate Patient-Reported Outcome Measures for Use in Men With Late Onset Hypogonadism [NCT00254553]	Phase 2	150 participants (Actual)	Interventional	2005-07-31	Terminated(stopped due to Recruitment issues)
Regulation of Cortisol Metabolism and Fat Patterning [NCT00694733]		140 participants (Actual)	Interventional	2005-05-31	Active, not recruiting
Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2) [NCT01327495]	Phase 2/Phase 3	62 participants (Actual)	Interventional	2011-10-31	Completed
Phase 4 Study That Evaluates the Effects of Two Different Testosterone Replacement Regiments on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism. [NCT01533129]	Phase 4	106 participants (Actual)	Interventional	2008-08-31	Completed
Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus (HIV)-Associated Wasting. [NCT00001079]	Phase 2	80 participants	Interventional		Completed
Physiologic Testosterone Replacement in Women With Hypopituitarism [NCT00144391]	Phase 4	20 participants (Actual)	Interventional	2003-07-31	Completed
A Prospective, Multicenter, Randomized, Placebo-Controlled Trial of Physiologic Testosterone Supplementation for HIV-Positive Men With Mildly to Moderately Reduced Serum Testosterone Levels and Abdominal Obesity [NCT00009555]	Phase 4	86 participants	Interventional		Completed
The Effect of Testosterone Supplementation on Rehabilitation Outcomes [NCT00037999]	Phase 2	60 participants (Anticipated)	Interventional	2001-04-30	Completed
Randomized Control Trial of Long Acting Subcutaneous Testosterone Pellets for Hypogonadism: Testopel ® vs. Generic Testosterone Pellets. [NCT04523480]	Phase 3	75 participants (Actual)	Interventional	2020-03-12	Completed
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women [NCT00141544]	Phase 2	28 participants (Actual)	Interventional	2004-07-31	Terminated(stopped due to Lack of enrollment)
Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme [NCT00847314]		30 participants (Actual)	Observational	2007-06-30	Completed
Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly [NCT00018356]	Phase 4	88 participants (Anticipated)	Interventional	1999-01-31	Completed
A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease [NCT00392912]		10 participants (Actual)	Interventional	2007-04-30	Completed
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty [NCT00345969]	Phase 3	25 participants (Actual)	Interventional	2004-11-30	Completed
A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride [NCT00398580]	Phase 2	43 participants (Actual)	Interventional	2006-10-31	Completed
Oral Androgens in Man-4: Gonadotropin Suppression Medicated by Oral Testosterone Enanthate in Oil Plus Dutasteride (Short Title: Oral T-4) [NCT00399165]	Phase 1/Phase 2	20 participants (Actual)	Interventional	2006-11-30	Completed
The Effect of Testosterone Treatment on Depressive Symptoms and Quality of Life in Older Men With Age-Related Hypogonadism and Subsyndromal Depression. [NCT00202462]		33 participants (Actual)	Interventional	2002-11-30	Completed
A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State and Compared to Testosterone Undecanoate in Adult Men W [NCT02966652]	Phase 1	25 participants (Actual)	Interventional	2016-11-03	Completed
Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals) [NCT00146146]	Phase 3	15 participants (Actual)	Interventional	2005-05-31	Completed
A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women [NCT00160342]	Phase 2	1,251 participants (Anticipated)	Interventional	2005-06-30	Completed
Hormonal Regulators of Muscle and Metabolism in Aging [NCT00183040]	Phase 2	108 participants (Anticipated)	Interventional	2002-09-30	Completed
Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men [NCT00190060]	Phase 4	262 participants (Actual)	Interventional	2004-10-31	Completed
Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial [NCT00405353]	Phase 1/Phase 2	10 participants (Actual)	Interventional	2002-04-30	Completed
5-Alpha Reductase and Anabolic Effects of Testosterone [NCT00475501]	Phase 2	60 participants (Actual)	Interventional	2007-01-31	Completed
Metabolic Effects of Androgenicity in Aging Men and Women [NCT00680797]		33 participants (Actual)	Interventional	2005-01-01	Completed
Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism [NCT00663793]	Phase 1	16 participants (Actual)	Interventional	2008-10-31	Completed
A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors [NCT00698035]	Phase 2	76 participants (Actual)	Interventional	2007-03-31	Completed
A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer [NCT02286921]	Phase 2	222 participants (Actual)	Interventional	2015-01-31	Completed
Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical Disabilities [NCT02990507]		40 participants (Actual)	Interventional	2017-02-10	Completed
A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism [NCT01270841]	Phase 2	83 participants (Actual)	Interventional	2011-01-31	Completed
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment [NCT02408445]	Phase 4	20 participants (Actual)	Interventional	2015-05-08	Completed
Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury [NCT01652040]	Phase 2/Phase 3	26 participants (Actual)	Interventional	2012-07-02	Completed
A Phase II Study of Bipolar Androgen-based Therapy for Men With Androgen Ablation NaÃ-ve Recurrent Prostate Cancer [NCT01750398]	Phase 2	33 participants (Actual)	Interventional	2013-01-31	Completed
A Phase 1, Single-Dose Study to Evaluate Testosterone on Clothing After Axiron® Use in Healthy Male Subjects [NCT02004132]	Phase 1	12 participants (Actual)	Interventional	2013-12-31	Completed
An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women With Low Testosterone and Hypoactive Sexual Desire Disorder [NCT06082817]	Phase 2	30 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
SPECTRA: SupraPhysiological Androgen to Enhance Chemotherapy TReatment Activity [NCT06039371]	Phase 2	46 participants (Anticipated)	Interventional	2024-01-01	Not yet recruiting
International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido) [NCT00410306]		1,493 participants (Actual)	Observational	2006-10-31	Completed
A Randomized Double-Blind Placebo-Controlled Study Comparing the Safety and Efficacy of Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction [NCT00202163]	Phase 2	120 participants (Anticipated)	Interventional	2006-12-31	Completed
The Effects of Anabolic Steroids and Protease Inhibitors on Serum Blood Lipids,Muscle Mass, and Total Body Fat in People Living With HIV/AIDS [NCT00202241]		30 participants	Interventional	1999-09-30	Completed
Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion. [NCT00230984]	Phase 3	200 participants	Interventional	2003-04-30	Completed
Mechanisms of Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men: Modulation of GHRH, GHRP and Somatostatin Action by Estrogenic Versus Androgenic Steroids [NCT00309855]	Phase 1	80 participants (Actual)	Interventional	2005-12-31	Completed
The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial [NCT01469988]	Phase 2	318 participants (Anticipated)	Interventional	2012-11-30	Terminated(stopped due to Feasibility)
A Randomized Double Blind Control Trial of Transdermal Testosterone Supplementation vs Placebo on Follicular Development and Atresia, Oocyte and Embryo Quality Among Women With Diminished Ovarian Reserve Undergoing in Vitro Fertilization [NCT01662466]	Phase 1/Phase 2	180 participants (Anticipated)	Interventional	2012-07-01	Recruiting
Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men [NCT01765179]	Phase 3	144 participants (Actual)	Interventional	2013-01-31	Completed
A Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Investigate the Safety and Efficacy of Lybridos in the Domestic Setting in Healthy Female Subjects With Hypoactive Sexual Desire Disorder and Maladaptive Activity of Sexual Inhibitory M [NCT01743235]	Phase 2	207 participants (Actual)	Interventional	2012-07-31	Completed
Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate [NCT01758029]		80 participants (Anticipated)	Observational	2013-01-31	Not yet recruiting
[NCT01758094]		25 participants (Actual)	Observational	2008-01-31	Completed
Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment [NCT01797718]	Phase 2/Phase 3	35 participants (Actual)	Interventional	2013-10-31	Completed
A Randomized and Double-blind Study to Evaluate the Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects [NCT01813201]	Phase 4	14 participants (Actual)	Interventional	2011-03-31	Completed
Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men [NCT01143818]		1,053 participants (Actual)	Observational	2007-12-31	Completed
A Phase II Study Assessing the Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer [NCT05081193]	Phase 2	30 participants (Anticipated)	Interventional	2022-03-07	Recruiting
A 24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated With Natesto Nasal Testosterone Gel [NCT04976595]	Phase 4	218 participants (Anticipated)	Interventional	2021-07-01	Recruiting
Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients [NCT03678233]	Phase 2	30 participants (Anticipated)	Interventional	2019-06-27	Recruiting
An Open-Label Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males: Effect of Washing or Clothing Barrier to the Application [NCT02994602]	Phase 1	12 participants (Actual)	Interventional	2017-01-31	Completed
Investigation of the Perceptual and Acoustic Characteristic of Voice in Trans Man [NCT05166083]		28 participants (Anticipated)	Observational [Patient Registry]	2022-03-11	Recruiting
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY [NCT03325647]	Phase 4	72 participants (Actual)	Interventional	2017-11-06	Completed
Collaborative Study: Testosterone Antidepressant Augmentation in Women [NCT01783574]		101 participants (Actual)	Interventional	2013-08-31	Completed
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men [NCT01686828]	Phase 1/Phase 2	53 participants (Actual)	Interventional	2013-06-30	Completed
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial [NCT05722301]	Phase 3	0 participants (Actual)	Interventional	2019-11-01	Withdrawn(stopped due to Study was never initiated.)
A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men [NCT01386606]	Phase 2	60 participants (Actual)	Interventional	2011-06-30	Completed
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical [NCT04342247]		30 participants (Actual)	Observational	2019-01-01	Completed
Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men. [NCT03242590]	Phase 3	95 participants (Actual)	Interventional	2016-12-31	Completed
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer [NCT01084759]		16 participants (Actual)	Interventional	2010-03-31	Completed
Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism.: a Prospective, Randomized and Controlled-Study [NCT00467987]		47 participants (Actual)	Interventional	2007-06-30	Terminated(stopped due to Company no longer making drug)
A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy [NCT02229617]	Phase 1/Phase 2	14 participants (Actual)	Interventional	2015-07-31	Completed
Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism [NCT01167829]	Phase 1	14 participants (Actual)	Interventional	2010-07-31	Completed
24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy. [NCT00384046]	Phase 3	272 participants (Actual)	Interventional	2006-11-30	Completed
An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels [NCT01364623]	Phase 1	24 participants (Actual)	Interventional	2011-09-30	Completed
Hormonal Factors in the Treatment of Anorexia Nervosa [NCT01121211]	Phase 2	90 participants (Actual)	Interventional	2010-04-30	Completed
IGF-1 and Bone Loss in Women Anorexia Nervosa [NCT00089843]	Phase 2/Phase 3	77 participants (Actual)	Interventional	2003-06-30	Completed
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy [NCT01201863]	Phase 4	46 participants (Actual)	Interventional	2010-09-30	Completed
A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II) [NCT04120363]	Phase 4	34 participants (Actual)	Interventional	2019-09-23	Completed
CYP19A1 Gene and Pharmacogenetics of Response [NCT01378299]	Phase 1	105 participants (Actual)	Interventional	2011-10-01	Completed
The Regulation of Skeletal Muscle Protein Synthesis by Systemic Hormones and Its Influence on Ageing and Anabolic Resistance [NCT03054168]	Phase 3	34 participants (Actual)	Interventional	2016-12-15	Active, not recruiting
Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) [NCT04558866]	Phase 2	51 participants (Actual)	Interventional	2021-04-30	Active, not recruiting
Hormones and Decision Making [NCT04865562]	Phase 4	30 participants (Actual)	Interventional	2015-03-01	Completed
Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort: a Randomized Clinical Trial [NCT03238092]	Phase 3	26 participants (Anticipated)	Interventional	2017-08-31	Not yet recruiting
Will Testosterone and Growth Hormone Improve Bone Structure? [NCT00080483]	Phase 2	35 participants (Actual)	Interventional	2004-03-31	Completed
Testosterone Replacement for Older Men With Sarcopenia [NCT00240981]	Phase 4	209 participants (Actual)	Interventional	2005-01-31	Terminated(stopped due to Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.)
Testosterone Supplementation and Exercise in Elderly Men [NCT00112151]	Phase 2	167 participants (Actual)	Interventional	2005-01-31	Completed
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy [NCT01697345]	Early Phase 1	12 participants (Actual)	Interventional	2013-02-28	Completed
A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Explore the Impact of Testosterone Solution 2% on Symptoms of Ejaculatory Dysfunction in Men With Testosterone Deficiency [NCT01419236]	Phase 2	76 participants (Actual)	Interventional	2011-08-31	Completed
A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males [NCT01665599]	Phase 3	180 participants (Actual)	Interventional	2012-07-31	Completed
The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery [NCT01595581]	Phase 3	14 participants (Actual)	Interventional	2012-04-30	Completed
A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism [NCT02504541]	Phase 3	133 participants (Actual)	Interventional	2015-07-31	Completed
An Open-Label, Nine-Month Randomized Controlled Study of Testosterone (Testopel) Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease [NCT01578473]	Phase 1	75 participants (Actual)	Interventional	2013-05-23	Completed
An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Administration With Marketed Testosterone Products [NCT04456296]	Phase 4	676 participants (Actual)	Interventional	2020-06-30	Completed
Effect of Testosterone and Diet on Weight [NCT01616732]	Phase 2	100 participants (Actual)	Interventional	2013-04-30	Completed
Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism [NCT04760574]		1,200 participants (Anticipated)	Observational [Patient Registry]	2021-02-02	Recruiting
Effect of Transgender Therapy on Hormone Receptors, Adipogenesis, Myogenesis and Inflammation [NCT04551144]		4 participants (Actual)	Observational	2020-10-06	Active, not recruiting
Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers. [NCT04757532]	Phase 1	9 participants (Actual)	Interventional	2020-12-03	Completed
Dose-Response of Gonadal Steroids and Bone Turnover in Older Men [NCT00114114]		177 participants (Actual)	Interventional	2004-09-30	Completed
A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment [NCT00304746]	Phase 4	100 participants (Actual)	Interventional	2006-04-30	Completed
A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects [NCT00372008]	Phase 2	40 participants (Anticipated)	Interventional	2006-10-31	Completed
Mechanisms of Control of the Intratesticular Hormonal Milieu in Man [NCT01215292]	Phase 1/Phase 2	46 participants (Actual)	Interventional	2011-01-31	Completed
A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients [NCT00631137]		1 participants (Actual)	Interventional	2008-01-31	Terminated(stopped due to Study terminated due to low accrual.)
A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin [NCT00349362]	Phase 4	40 participants (Anticipated)	Interventional	2006-07-31	Completed
A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 24 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy. [NCT00349791]	Phase 3	549 participants (Actual)	Interventional	2002-06-30	Completed
A Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males [NCT01703741]	Phase 3	145 participants (Actual)	Interventional	2012-12-31	Completed
A Phase 2 Study of the Effect of Meals With Various Amounts of Fat Given Immediately After Dosing on the Pharmacokinetics of an Oral Testosterone Undecanoate [NCT02921386]	Phase 2	18 participants (Actual)	Interventional	2016-10-31	Completed
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome [NCT00433173]		72 participants (Anticipated)	Interventional	2006-05-31	Suspended(stopped due to Primary investigator is taking a leave of absence)
Testosterone and Long Pulse Width Stimulation for Denervated Muscles After Spinal Cord Injury [NCT03345576]	Phase 2	12 participants (Actual)	Interventional	2018-07-01	Completed
Psychological and Motor Effects of Testosterone Therapy in Adolescents With XXY/Klinefelter Syndrome [NCT01585831]		48 participants (Actual)	Interventional	2012-03-31	Completed
Effect of Increasing Testosterone Levels on Insulin Sensitivity in Men With the Metabolic Syndrome [NCT00382057]	Phase 2	72 participants (Anticipated)	Interventional	2006-05-31	Withdrawn
[NCT00004400]	Phase 2	56 participants (Anticipated)	Interventional	1997-04-30	Completed
[NCT00004771]	Phase 2	40 participants	Interventional	1992-10-31	Completed
Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome [NCT01909141]	Early Phase 1	100 participants (Actual)	Interventional	2013-08-31	Completed
Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences [NCT04265053]	Early Phase 1	144 participants (Anticipated)	Interventional	2021-04-12	Recruiting
Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters [NCT03203681]	Phase 4	60 participants (Actual)	Interventional	2017-10-27	Completed
A Randomised, Double Blind, Placebo-controlled Parallel Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus [NCT00355537]	Phase 4	19 participants (Actual)	Interventional	2006-02-28	Completed
A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne) [NCT03198728]	Phase 3	314 participants (Actual)	Interventional	2017-07-05	Completed
Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study [NCT03518034]	Phase 4	5,246 participants (Actual)	Interventional	2018-05-03	Completed
Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury [NCT03576001]	Phase 2	88 participants (Anticipated)	Interventional	2019-08-23	Recruiting
Intranasal Delivery of Testosterone and Its Effect on Doping Markers [NCT02611154]	Phase 4	5 participants (Actual)	Interventional	2015-11-18	Completed
Phase IIa, Pilot, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men [NCT02697188]	Phase 2	12 participants (Actual)	Interventional	2007-11-30	Completed
Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men [NCT02670343]	Phase 1/Phase 2	8 participants (Actual)	Interventional	2016-01-31	Completed
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial [NCT02734238]	Phase 4	53 participants (Actual)	Interventional	2016-04-30	Completed
Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters. [NCT04336891]		81 participants (Actual)	Observational	2019-03-20	Completed
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men. [NCT03242408]	Phase 3	100 participants (Actual)	Interventional	2017-01-31	Completed
Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men [NCT01155518]	Phase 2	5 participants (Actual)	Interventional	2010-06-30	Terminated(stopped due to lack of funding)
Testosterone Treatment in a Patient With 17β-hydroxysteroid Dehydrogenase Type 3 Deficiency: an N-of-1 Study [NCT04831099]	Phase 3	1 participants (Anticipated)	Interventional	2021-06-01	Not yet recruiting
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis [NCT03910738]	Phase 2	40 participants (Anticipated)	Interventional	2019-10-29	Recruiting
A Multicenter, Open Label, Variable Dose, Two Arm Pilot Paediatric Phase 1 PK Study to Evaluate Testosterone Nasal Gel (4.5% w/w) in Hypogonadal Boys [NCT03345797]	Phase 1	8 participants (Actual)	Interventional	2018-03-01	Terminated(stopped due to Lack of patients and commercial reasons)
Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization [NCT03289559]		13 participants (Actual)	Interventional	2006-01-01	Completed
Pilot Randomized, Controlled Trial of Testosterone Therapy in Chronic Critically Ill Patients and Its Potential Effects on Weaning From Mechanical Ventilation and Intensive Care Unit-acquired Weakness [NCT03038919]	Phase 2/Phase 3	30 participants (Anticipated)	Interventional	2016-10-31	Recruiting
A Phase 3, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males [NCT02149264]	Phase 3	160 participants (Actual)	Interventional	2014-07-31	Completed
Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans [NCT02367105]	Phase 3	83 participants (Actual)	Interventional	2015-02-01	Completed
Baseline Testosterone as a Prognostic and/or Predictive Biomarker in Metastatic Hormone Sensitive Prostate Cancer [NCT05530395]		300 participants (Anticipated)	Observational	2023-01-01	Not yet recruiting
A Randomized, Two Center, Double-Blind Trial to Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Healthy Men [NCT02432261]	Phase 1	44 participants (Actual)	Interventional	2015-04-30	Completed
Clinical, Microbiologic and Immunologic Profile of the Periodontal Condition in Hypogonadic Men [NCT03176537]	Phase 4	0 participants (Actual)	Interventional	2017-05-01	Withdrawn(stopped due to No eligible participants for the RCT were found)
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence [NCT03116087]		60 participants (Actual)	Interventional	2007-03-01	Completed
Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO) [NCT02418065]	Phase 3	120 participants (Anticipated)	Interventional	2013-12-31	Recruiting
Effectiveness of Testosterone Replacement Therapy (TRT) on Prostatic Gland in Hypogonadal Patients Affected by Benign Prostatic Hyperplasia (BPH) and Metabolic Syndrome (MetS). Florence-PROTEST [NCT02366975]	Phase 4	143 participants (Actual)	Interventional	2012-11-30	Completed
Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors. Double Blind, 2x2 Factorial, Randomized Placebo--Controlled Clinical Trial [NCT02419105]	Phase 3	91 participants (Actual)	Interventional	2015-09-30	Terminated(stopped due to Delayed recruitment mainly due to a screening to inclusion rate much lower than expected. Due to the delayed recruitment IMP reached the end of its shelf life.)
Transdermal Testosterone for Poor Responders Undergoing IVF [NCT03078569]	Phase 4	30 participants (Anticipated)	Interventional	2017-03-31	Recruiting
Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias [NCT01573442]	Phase 3	227 participants (Actual)	Interventional	2013-08-31	Completed
A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone. [NCT00706719]	Phase 2	17 participants (Actual)	Interventional	2008-06-30	Completed
An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects [NCT02233751]	Phase 1	12 participants (Actual)	Interventional	2014-09-30	Completed
A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention) [NCT02991209]	Phase 2/Phase 3	69 participants (Actual)	Interventional	2016-11-30	Completed
Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men [NCT00975650]	Phase 2	57 participants (Actual)	Interventional	2009-08-31	Completed
A Pilot Study To Evaluate The Effect of Testosterone Enanthate On Structural and Functional Characteristics of Pelvic Floor Muscles In Postmenopausal Women With Urinary Incontinence [NCT04026880]	Phase 3	0 participants (Actual)	Interventional	2021-01-01	Withdrawn(stopped due to Lack of funds)
A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application [NCT01464879]	Phase 2	20 participants (Actual)	Interventional	2011-12-31	Completed
Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI [NCT02248701]	Phase 2	33 participants (Actual)	Interventional	2017-04-27	Terminated(stopped due to Enrollment difficulties)
A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer [NCT02995330]	Phase 1	3 participants (Actual)	Interventional	2017-02-09	Terminated(stopped due to lack of accrual)
Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution [NCT01725451]	Phase 1	30 participants (Actual)	Interventional	2012-11-30	Completed
Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction: A Double-blinded Randomized Controlled Clinical Trial [NCT03834610]		108 participants (Actual)	Interventional	2017-10-01	Completed
Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT01699178]	Phase 3	182 participants (Actual)	Interventional	2012-08-31	Completed
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency [NCT03716739]	Phase 2	142 participants (Anticipated)	Interventional	2019-03-19	Recruiting
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel [NCT01893281]	Phase 4	78 participants (Actual)	Interventional	2013-07-31	Completed
Effects of Testosterone in Women With Depression: A Pilot Study [NCT00676676]		9 participants (Actual)	Interventional	2007-03-31	Completed
A Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple Sclerosis [NCT03000127]	Phase 2	0 participants (Actual)	Interventional	2018-07-01	Withdrawn(stopped due to Lack of funding)
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men [NCT01252745]	Phase 2	22 participants (Actual)	Interventional	2010-08-31	Completed
Optimizing Protein Intake in Older Americans With Mobility Limitations [NCT01275365]	Phase 3	92 participants (Actual)	Interventional	2011-05-31	Completed
A Phase 2 Open-Label, Sequential Dose Escalation Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Three Volumes (1.25, 2.50 and 3.75 mL) of Testosterone Gel 2% (FE 999303) Equivalent to 23, 46 And 70 mg of Testosterone in Hypogonadal Males [NCT01370369]	Phase 2	20 participants (Actual)	Interventional	2011-05-31	Completed
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT01403116]	Phase 3	325 participants (Actual)	Interventional	2011-07-31	Completed
A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men [NCT01816295]	Phase 3	715 participants (Actual)	Interventional	2013-05-31	Completed
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women [NCT03314298]	Phase 1	11 participants (Actual)	Interventional	2017-08-14	Completed
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT02722278]	Phase 3	222 participants (Actual)	Interventional	2016-03-31	Completed
Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study [NCT05586802]	Phase 3	120 participants (Anticipated)	Interventional	2023-03-21	Recruiting
A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence [NCT06111209]	Phase 2	30 participants (Anticipated)	Interventional	2024-05-31	Not yet recruiting
A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days [NCT01446042]	Phase 3	306 participants (Actual)	Interventional	2011-09-30	Completed
CMV IGG Antibodies in Semen as a Predictor for Blood Testis Barrier Damage [NCT05302856]		30 participants (Anticipated)	Interventional	2022-03-02	Recruiting
Sexual Function Before and After Bariatric Surgeries. [NCT05390203]		55 participants (Anticipated)	Observational	2022-08-01	Not yet recruiting
Clinical Effect of Follicular Preparation With Testosterone in Poor Ovarian Response: a Randomized Controlled Clinical Trial (TESTOPRIM) [NCT03378713]	Phase 3	63 participants (Actual)	Interventional	2017-08-07	Completed
Hormonal Mechanisms of Sleep Restriction [NCT02256865]	Early Phase 1	40 participants (Actual)	Interventional	2014-10-31	Completed
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer [NCT00587431]	Phase 2	102 participants (Actual)	Interventional	2003-07-31	Completed
Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism [NCT00350701]	Phase 4	49 participants (Actual)	Interventional	2006-07-31	Completed
A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy (BAT) Followed by Enzalutamide or Abiraterone Post-BAT in Men With Prostate Cancer Progressing on Combined Androgen Ablative Therapies [NCT02090114]	Phase 2	112 participants (Actual)	Interventional	2014-08-25	Completed
Cardiovascular Consequences of Hypogonadism in Men [NCT02758431]		379 participants (Anticipated)	Interventional	2016-07-01	Active, not recruiting
Randomized, Double-blind, Parallel, Placebo-controlled, Clinical Trial to Assess the Efficacy of Testosterone, Metformin, or Both, for the Treatment of Obesity-induced Male Hypogonadism [NCT02514629]	Phase 3	107 participants (Actual)	Interventional	2013-07-04	Completed
3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males [NCT01887418]	Phase 1/Phase 2	39 participants (Actual)	Interventional	2013-09-30	Completed
A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism [NCT02159469]	Phase 3	150 participants (Actual)	Interventional	2014-07-31	Completed
A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism [NCT01717768]	Phase 2	130 participants (Actual)	Interventional	2012-10-31	Completed
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome [NCT04327934]	Early Phase 1	22 participants (Actual)	Interventional	2017-12-01	Completed
24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy [NCT04274894]	Phase 4	246 participants (Actual)	Interventional	2020-05-12	Completed
A Phase 2B Study to Determine the Dose Response Pharmacokinetics of TSX-002 (Testosterone) in Hypogonadal Males [NCT02222558]	Phase 2	25 participants (Actual)	Interventional	2014-09-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00080483 (1) [back to overview]	MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.
NCT00089843 (2) [back to overview]	Markers of Bone Metabolism
NCT00089843 (2) [back to overview]	Bone Mineral Density
NCT00095212 (11) [back to overview]	Safety: Number of Subjects Reporting a Skin Reaction to the Patch
NCT00095212 (11) [back to overview]	Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)
NCT00095212 (11) [back to overview]	Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)
NCT00095212 (11) [back to overview]	Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function
NCT00095212 (11) [back to overview]	Quality of Life/Depression: Becks Depression Inventory
NCT00095212 (11) [back to overview]	Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.
NCT00095212 (11) [back to overview]	Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.
NCT00095212 (11) [back to overview]	Safety: Number of Subjects Reporting Acne
NCT00095212 (11) [back to overview]	Lean Body Mass
NCT00095212 (11) [back to overview]	Bone Mineral Density of the Hip
NCT00095212 (11) [back to overview]	"Neurocognitive Function: Hopkins Verbal Learning Test-revised,Total Recall Z Score Represents Change in Z Score From Baseline to 18 Months."
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
NCT00104572 (4) [back to overview]	Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism
NCT00112151 (6) [back to overview]	Lower Body Muscle Strength (1-RM, kg)
NCT00112151 (6) [back to overview]	Fat Free Mass (kg)
NCT00112151 (6) [back to overview]	Physical Function (CS-PFP Total Score)
NCT00112151 (6) [back to overview]	Fat Mass (kg)
NCT00112151 (6) [back to overview]	Power (Power Rig, Watts)
NCT00112151 (6) [back to overview]	Upper Body Muscle Strength (1-RM, kg)
NCT00114114 (5) [back to overview]	Change in Erectile Function Symptoms
NCT00114114 (5) [back to overview]	Change in Libido / Sexual Desire
NCT00114114 (5) [back to overview]	Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)
NCT00114114 (5) [back to overview]	Percentage Change in Body Composition: Fat Mass
NCT00114114 (5) [back to overview]	Percentage Change in Thigh Muscle Area
NCT00144391 (1) [back to overview]	Fatigue Impact Scale
NCT00194675 (6) [back to overview]	Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
NCT00194675 (6) [back to overview]	Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
NCT00194675 (6) [back to overview]	Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
NCT00194675 (6) [back to overview]	Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
NCT00194675 (6) [back to overview]	Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
NCT00194675 (6) [back to overview]	The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)
NCT00239590 (2) [back to overview]	Myocardial Perfusion
NCT00239590 (2) [back to overview]	Endothelial Function
NCT00240981 (10) [back to overview]	Grip Strength
NCT00240981 (10) [back to overview]	Late Life Functional Disability Index (LLFDI)
NCT00240981 (10) [back to overview]	Stair-climbing Test (Loaded)
NCT00240981 (10) [back to overview]	50-Meter Walking Speed (With a Load)
NCT00240981 (10) [back to overview]	Total Fat Mass
NCT00240981 (10) [back to overview]	Total Lean Mass
NCT00240981 (10) [back to overview]	Stair-climbing Test (Without a Load)
NCT00240981 (10) [back to overview]	50-Meter Walking Speed (Without a Load)
NCT00240981 (10) [back to overview]	Changes in Physical Performance Measured by an Exercise Testing Regimen
NCT00240981 (10) [back to overview]	Chest-Press
NCT00266864 (2) [back to overview]	Resting Energy Expenditure
NCT00266864 (2) [back to overview]	Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)
NCT00287586 (14) [back to overview]	Change From Baseline in Chest Press Strength and Leg Press Strength
NCT00287586 (14) [back to overview]	Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)
NCT00287586 (14) [back to overview]	Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)
NCT00287586 (14) [back to overview]	Change From Baseline in Lipid Profiles
NCT00287586 (14) [back to overview]	Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)
NCT00287586 (14) [back to overview]	Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)
NCT00287586 (14) [back to overview]	Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power
NCT00287586 (14) [back to overview]	Change From Baseline in the Verbal Fluency Test
NCT00287586 (14) [back to overview]	Change From Baseline in Coronary Artery Calcium Score
NCT00287586 (14) [back to overview]	Change From Baseline in Paragraph Recall Test (Delayed)
NCT00287586 (14) [back to overview]	Change From Baseline in the Trail Making Test B
NCT00287586 (14) [back to overview]	Change From Baseline in the Stroop Interference Test
NCT00287586 (14) [back to overview]	Change From Baseline in the Category Fluency Test
NCT00287586 (14) [back to overview]	Change From Baseline in the Buschke Selective Reminding Test (Delayed)
NCT00304746 (2) [back to overview]	Montgomery Asberg Depression Rating Scale (MADRS)
NCT00304746 (2) [back to overview]	21-item Hamilton Depression Rating Scale Score (HAM-D)
NCT00345969 (13) [back to overview]	Change in Serum Testosterone Level
NCT00345969 (13) [back to overview]	Change in Skeletal Muscle Strength by 1-RM
NCT00345969 (13) [back to overview]	Change in Serum Total Cholesterol Level
NCT00345969 (13) [back to overview]	Mean Change in Total Lean Body Mass
NCT00345969 (13) [back to overview]	Change in Total Body Fat Mass
NCT00345969 (13) [back to overview]	Change in Femoral Bone Mineral Density (BMD)
NCT00345969 (13) [back to overview]	Change in Hematocrit
NCT00345969 (13) [back to overview]	Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
NCT00345969 (13) [back to overview]	Change in Serum Prostate Specific Antigen (PSA) Level
NCT00345969 (13) [back to overview]	Change in Leg Extension Torque at 60 Deg/Sec
NCT00345969 (13) [back to overview]	Change in Serum HDL Cholesterol Level
NCT00345969 (13) [back to overview]	Change in Serum LDL Cholesterol Level
NCT00345969 (13) [back to overview]	Change in Total Modified Physical Performance (mPPT) Score
NCT00350701 (3) [back to overview]	Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
NCT00350701 (3) [back to overview]	Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
NCT00350701 (3) [back to overview]	Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
NCT00351819 (22) [back to overview]	Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14
NCT00351819 (22) [back to overview]	Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
NCT00351819 (22) [back to overview]	Ice Water-induced Cold Pain and Its After-sensation at Week 14
NCT00351819 (22) [back to overview]	Inflammatory Cytokines at Week 14
NCT00351819 (22) [back to overview]	Lipid Profile at Week 14
NCT00351819 (22) [back to overview]	Pain Catastrophizing Scale (PCS) at Week 14
NCT00351819 (22) [back to overview]	Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
NCT00351819 (22) [back to overview]	Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14
NCT00351819 (22) [back to overview]	Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14
NCT00351819 (22) [back to overview]	Adiponectin at Week 14
NCT00351819 (22) [back to overview]	C-reactive Protein (CRP) at Week 14
NCT00351819 (22) [back to overview]	Free Testosterone Values at Week 14
NCT00351819 (22) [back to overview]	HbA1c at Week 14
NCT00351819 (22) [back to overview]	HOMA IR Score at Week 14
NCT00351819 (22) [back to overview]	Insomnia Severity Index (ISI) at Week 14
NCT00351819 (22) [back to overview]	Leptin at Week 14
NCT00351819 (22) [back to overview]	Luteinizing Hormone Values at Week 14
NCT00351819 (22) [back to overview]	Sex Hormone Binding Globulin (SHBG) at Week 14
NCT00351819 (22) [back to overview]	Total Testosterone Values at Week 14
NCT00351819 (22) [back to overview]	Algometer-induced Pressure Pain at Week 14
NCT00351819 (22) [back to overview]	Body Composition at Week 14
NCT00351819 (22) [back to overview]	Brief Pain Inventory (BPI) at Week 14
NCT00365794 (10) [back to overview]	Change in Basal FFAs in Plasma
NCT00365794 (10) [back to overview]	Change in Hepatic Lipid
NCT00365794 (10) [back to overview]	Change in HOMA-IR
NCT00365794 (10) [back to overview]	Change in Percentage of Total Body Fat
NCT00365794 (10) [back to overview]	Change in Plasma Free Fatty Acids During Glucose Clamp
NCT00365794 (10) [back to overview]	Change in Skeletal Muscle Mass by DEXA
NCT00365794 (10) [back to overview]	Intramyocellular Lipid (IMCL)
NCT00365794 (10) [back to overview]	Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO])
NCT00365794 (10) [back to overview]	Change in Total Mass and Regional Adipose Adiposiy
NCT00365794 (10) [back to overview]	Plasma Lipids
NCT00405353 (1) [back to overview]	Whole Brain Atrophy Rate
NCT00413244 (10) [back to overview]	IIEF-IV: Intercourse Satisfaction
NCT00413244 (10) [back to overview]	IIEF-II Orgasmic Function
NCT00413244 (10) [back to overview]	IIEF -III: Sexual Desire
NCT00413244 (10) [back to overview]	Cardiac Stress Testing: Exercise Capacity
NCT00413244 (10) [back to overview]	Cardiac Stress Test: Time to ST Depression
NCT00413244 (10) [back to overview]	Aging Male Symptoms (AMS)
NCT00413244 (10) [back to overview]	Metabolic Equivalents of Task (METS)
NCT00413244 (10) [back to overview]	Reactive Hyperemia Index
NCT00413244 (10) [back to overview]	International Index of Erectile Function (IIEF)
NCT00413244 (10) [back to overview]	IIEF-V: Over-all Satisfaction
NCT00433199 (6) [back to overview]	Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
NCT00433199 (6) [back to overview]	Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
NCT00433199 (6) [back to overview]	Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
NCT00433199 (6) [back to overview]	Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
NCT00433199 (6) [back to overview]	Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
NCT00433199 (6) [back to overview]	Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
NCT00467259 (3) [back to overview]	Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1
NCT00467259 (3) [back to overview]	Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1
NCT00467259 (3) [back to overview]	Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1
NCT00467870 (35) [back to overview]	Serum Total Testosterone Maximum Concentration in Part B
NCT00467870 (35) [back to overview]	Serum Total Testosterone Maximum Concentration in Part C2
NCT00467870 (35) [back to overview]	Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Change in Body Mass Index From Baseline to Week 24 in Part C
NCT00467870 (35) [back to overview]	Change in Weight From Baseline to Week 24 in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone Concentrations in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Trough Assessments of Serum Total Testosterone Concentrations in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2
NCT00467870 (35) [back to overview]	Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2
NCT00467870 (35) [back to overview]	Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2
NCT00467870 (35) [back to overview]	Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone Maximum Concentration in Part A
NCT00475501 (11) [back to overview]	Dietary Protein Intake
NCT00475501 (11) [back to overview]	Transrectal Ultrasound Sizing of Prostate
NCT00475501 (11) [back to overview]	Trail-Making Test, Part A
NCT00475501 (11) [back to overview]	1 Repetition Maximum (1-RM) Strength Testing
NCT00475501 (11) [back to overview]	Lumbar Spine L2-L4 Bone Mineral Density
NCT00475501 (11) [back to overview]	30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test
NCT00475501 (11) [back to overview]	Benton Judgment of Line Orientation Test
NCT00475501 (11) [back to overview]	Life Satisfaction
NCT00475501 (11) [back to overview]	Hematocrit
NCT00475501 (11) [back to overview]	Grip Strength kg
NCT00475501 (11) [back to overview]	Geriatric Depression Scale
NCT00490555 (5) [back to overview]	Prostate-specific Antigen (PSA)
NCT00490555 (5) [back to overview]	Androstenedione (AED)
NCT00490555 (5) [back to overview]	Dihydrotestosterone (DHT) Concentration
NCT00490555 (5) [back to overview]	Testosterone Concentration
NCT00490555 (5) [back to overview]	Dehydroepiandrosterone (DHEA)
NCT00504712 (2) [back to overview]	Change in Arterial Stiffness
NCT00504712 (2) [back to overview]	Change in IMT
NCT00512707 (13) [back to overview]	Change From Baseline in Sexual Encounter Profile (SEP)
NCT00512707 (13) [back to overview]	Change From Baseline in Sex Hormone Binding Globulin (SHBG)
NCT00512707 (13) [back to overview]	Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)
NCT00512707 (13) [back to overview]	Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)
NCT00512707 (13) [back to overview]	Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)
NCT00512707 (13) [back to overview]	Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)
NCT00512707 (13) [back to overview]	Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)
NCT00512707 (13) [back to overview]	Change From Baseline in Free Testosterone
NCT00512707 (13) [back to overview]	Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)
NCT00512707 (13) [back to overview]	Change From Baseline in Derogatis Affects Balance Scale (DABS)
NCT00512707 (13) [back to overview]	Change From Baseline in Psychological General Well-Being Index Score (PGWBI)
NCT00512707 (13) [back to overview]	Change From Baseline in Total Testosterone
NCT00512707 (13) [back to overview]	Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)
NCT00522431 (2) [back to overview]	Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
NCT00522431 (2) [back to overview]	Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
NCT00539305 (4) [back to overview]	Behavioral & Mood Measure: Profile of Mood States (POMS)
NCT00539305 (4) [back to overview]	Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test
NCT00539305 (4) [back to overview]	Geriatric Depression Scale (GDS)
NCT00539305 (4) [back to overview]	Short-Form Health Survey (SF-36)
NCT00586898 (1) [back to overview]	Response
NCT00587431 (2) [back to overview]	PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
NCT00587431 (2) [back to overview]	The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
NCT00663793 (3) [back to overview]	Area Under the Curve-Serum T
NCT00663793 (3) [back to overview]	Area Under the Curve-E2
NCT00663793 (3) [back to overview]	Area Under the Curve-serum DHT
NCT00676676 (1) [back to overview]	Montgomery-Asberg Depression Rating Scale (MADRS) Scale
NCT00680797 (1) [back to overview]	Insulin Sensitivity
NCT00695110 (4) [back to overview]	Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
NCT00695110 (4) [back to overview]	Serum Testosterone Average Concentration (Cavg) (ng/dL)
NCT00695110 (4) [back to overview]	Serum Testosterone Average Concentration (Cavg) (ng/dL)
NCT00695110 (4) [back to overview]	Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
NCT00698035 (7) [back to overview]	Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
NCT00698035 (7) [back to overview]	Total Testosterone Levels
NCT00698035 (7) [back to overview]	Sexual Satisfaction
NCT00698035 (7) [back to overview]	Sexual Quality of Life
NCT00698035 (7) [back to overview]	Matched E2 by Commercial and Research (RIA) Analyses
NCT00698035 (7) [back to overview]	Serum Estradiol (E2)
NCT00698035 (7) [back to overview]	Change in Vaginal Epithelium Scores
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Haemoglobin
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)
NCT00702650 (15) [back to overview]	Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120
NCT00702650 (15) [back to overview]	Percentage of Participants With Cmax >2500 ng/dL
NCT00702650 (15) [back to overview]	Percentage of Participants With Cmax Between 1800 and 2500 ng/dL
NCT00702650 (15) [back to overview]	Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL
NCT00702650 (15) [back to overview]	Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Psychosexual Daily Questionnaire
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Draize Score
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Estradiol
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Fasting Glucose
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Fasting Insulin
NCT00702650 (15) [back to overview]	Change From Baseline to Endpoint in Haematocrit
NCT00706719 (5) [back to overview]	Luteinizing Hormone (LH) Levels
NCT00706719 (5) [back to overview]	Motile Total Sperm Count
NCT00706719 (5) [back to overview]	Semen Volume
NCT00706719 (5) [back to overview]	Sperm Concentration
NCT00706719 (5) [back to overview]	Follicle Stimulating Hormone (FSH) Levels
NCT00729859 (10) [back to overview]	Estradiol Concentration
NCT00729859 (10) [back to overview]	Endothelial Progenitor Cells
NCT00729859 (10) [back to overview]	Fasting Serum Insulin
NCT00729859 (10) [back to overview]	Sex Hormone Binding Globulin (SHBG)
NCT00729859 (10) [back to overview]	Fasting Lipid Levels
NCT00729859 (10) [back to overview]	Follicle Stimulating Hormone (FSH)
NCT00729859 (10) [back to overview]	Homeostasis Model of Insulin Resistance (HOMA-IR)
NCT00729859 (10) [back to overview]	Luteinizing Hormone Concentration (LH)
NCT00729859 (10) [back to overview]	Quantitative Insulin Sensitivity Check Index (QUICKI)
NCT00729859 (10) [back to overview]	Testosterone Concentration
NCT00755183 (2) [back to overview]	Meibomian Gland Secretion Appearance at Visit 4 (Day 168)
NCT00755183 (2) [back to overview]	Ocular Discomfort Score at Visit 4
NCT00799617 (37) [back to overview]	Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)
NCT00799617 (37) [back to overview]	Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone
NCT00799617 (37) [back to overview]	Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)
NCT00799617 (37) [back to overview]	Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline
NCT00799617 (37) [back to overview]	Cardiovascular Trial - Total Plaque Volume Change From Baseline
NCT00799617 (37) [back to overview]	Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia
NCT00799617 (37) [back to overview]	Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)
NCT00799617 (37) [back to overview]	Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume
NCT00799617 (37) [back to overview]	Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)
NCT00799617 (37) [back to overview]	Cognitive Function Trial - Executive Function - Trail Making Test B - A
NCT00799617 (37) [back to overview]	Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)
NCT00799617 (37) [back to overview]	Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)
NCT00799617 (37) [back to overview]	Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
NCT00799617 (37) [back to overview]	Physical Function Trial - PF 10 Overall Score
NCT00799617 (37) [back to overview]	Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
NCT00799617 (37) [back to overview]	Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)
NCT00799617 (37) [back to overview]	Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
NCT00799617 (37) [back to overview]	Sexual Function Trial - Erectile Function
NCT00799617 (37) [back to overview]	Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N
NCT00799617 (37) [back to overview]	Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
NCT00799617 (37) [back to overview]	Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
NCT00799617 (37) [back to overview]	Vitality Trial - FACIT Fatigue Overall Score
NCT00799617 (37) [back to overview]	Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
NCT00799617 (37) [back to overview]	Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)
NCT00799617 (37) [back to overview]	Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
NCT00799617 (37) [back to overview]	Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)
NCT00799617 (37) [back to overview]	Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)
NCT00799617 (37) [back to overview]	Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)
NCT00799617 (37) [back to overview]	Vitality Trial - SF-36 Score
NCT00799617 (37) [back to overview]	Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N
NCT00799617 (37) [back to overview]	Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N
NCT00799617 (37) [back to overview]	Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N
NCT00799617 (37) [back to overview]	Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N
NCT00799617 (37) [back to overview]	Sexual Function Trial - Sexual Desire Domain
NCT00799617 (37) [back to overview]	Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N
NCT00799617 (37) [back to overview]	Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)
NCT00799617 (37) [back to overview]	Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)
NCT00805207 (9) [back to overview]	Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis
NCT00805207 (9) [back to overview]	Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration
NCT00805207 (9) [back to overview]	Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration
NCT00805207 (9) [back to overview]	Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate
NCT00805207 (9) [back to overview]	VLDL-TG Plasma Clearance Rate (Means)
NCT00805207 (9) [back to overview]	Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate
NCT00805207 (9) [back to overview]	VLDL-TG Plasma Clearance Rate (Medians)
NCT00805207 (9) [back to overview]	VLDL-TG Plasma Clearance Rate (Medians)
NCT00805207 (9) [back to overview]	VLDL-TG Plasma Clearance Rate (Means)
NCT00839319 (4) [back to overview]	Intratesticular Testosterone (ITT-T)
NCT00839319 (4) [back to overview]	Serum Follicle Stimulating Hormone (FSH)
NCT00839319 (4) [back to overview]	Serum Luteinizing Hormone (LH)
NCT00839319 (4) [back to overview]	Serum Testosterone (T)
NCT00848497 (4) [back to overview]	Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.
NCT00848497 (4) [back to overview]	Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
NCT00848497 (4) [back to overview]	Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
NCT00848497 (4) [back to overview]	Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Follow-up in Estradiol
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Endpoint in Draize Score
NCT00857454 (8) [back to overview]	Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose
NCT00857961 (7) [back to overview]	Number of Participants With Adverse Events
NCT00857961 (7) [back to overview]	Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
NCT00857961 (7) [back to overview]	Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
NCT00857961 (7) [back to overview]	Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
NCT00857961 (7) [back to overview]	Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
NCT00857961 (7) [back to overview]	Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
NCT00857961 (7) [back to overview]	Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks
NCT00878995 (47) [back to overview]	1-year Survival
NCT00878995 (47) [back to overview]	Body Weight as Measured by Scale at 7 Weeks.
NCT00878995 (47) [back to overview]	Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline
NCT00878995 (47) [back to overview]	Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline
NCT00878995 (47) [back to overview]	Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline
NCT00878995 (47) [back to overview]	Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks
NCT00878995 (47) [back to overview]	Body Weight as Measured by Scale at Baseline
NCT00878995 (47) [back to overview]	Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks
NCT00878995 (47) [back to overview]	Physical Activity Levels as Measured by the ActiGraph Accelerometer
NCT00878995 (47) [back to overview]	Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks
NCT00878995 (47) [back to overview]	Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline
NCT00878995 (47) [back to overview]	Mood Measured by Profile of Mood States at Baseline
NCT00878995 (47) [back to overview]	Mood as Measured by Profile of Mood States at 7 Weeks
NCT00878995 (47) [back to overview]	Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline
NCT00878995 (47) [back to overview]	Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.
NCT00878995 (47) [back to overview]	Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.
NCT00878995 (47) [back to overview]	Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks
NCT00878995 (47) [back to overview]	Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline
NCT00878995 (47) [back to overview]	Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks
NCT00878995 (47) [back to overview]	Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks
NCT00878995 (47) [back to overview]	Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline
NCT00878995 (47) [back to overview]	Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks
NCT00878995 (47) [back to overview]	Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.
NCT00891228 (5) [back to overview]	The Number of Men Who Have Azoospermia
NCT00891228 (5) [back to overview]	The Impact on Sperm Morphology in Men Who Are Not Azoospermic
NCT00891228 (5) [back to overview]	The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.
NCT00891228 (5) [back to overview]	The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.
NCT00891228 (5) [back to overview]	The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.
NCT00911586 (2) [back to overview]	Serum T Concentration at Steady State
NCT00911586 (2) [back to overview]	Serum T Concentration at Steady-State
NCT00924612 (1) [back to overview]	Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
NCT00957528 (6) [back to overview]	9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
NCT00957528 (6) [back to overview]	Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months
NCT00957528 (6) [back to overview]	Changes in Serum Markers of Bone Turnover.
NCT00957528 (6) [back to overview]	Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months
NCT00957528 (6) [back to overview]	Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)
NCT00957528 (6) [back to overview]	Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)
NCT00957801 (40) [back to overview]	Hematocrit Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]	Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]	Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]	Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]	Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
NCT00957801 (40) [back to overview]	Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
NCT00957801 (40) [back to overview]	Triglycerides Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Hematocrit Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Insulin Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Insulin Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Total Cholesterol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Triglycerides Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured on Treatment Day 4
NCT00957801 (40) [back to overview]	Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Serum Estradiol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured on Treatment Day 2
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured on Treatment Day 3
NCT00957801 (40) [back to overview]	Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured on Treatment Day 5
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured on Treatment Day 6
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured on Treatment Day 7
NCT00957801 (40) [back to overview]	Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]	Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
NCT00965341 (2) [back to overview]	Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)
NCT00965341 (2) [back to overview]	The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).
NCT00975650 (7) [back to overview]	Percentage of Subjects With Cavg Within the Reference Range
NCT00975650 (7) [back to overview]	Serum Testosterone Ln-Cmax
NCT00975650 (7) [back to overview]	Serum Testosterone Ln-AUCt
NCT00975650 (7) [back to overview]	Serum Testosterone Cavg
NCT00975650 (7) [back to overview]	Serum Dihydrotestosterone Ln-Cmax
NCT00975650 (7) [back to overview]	Serum Dihydrotestosterone Ln-AUCt
NCT00975650 (7) [back to overview]	Serum Dihydrotestosterone Cavg
NCT01084759 (3) [back to overview]	Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)
NCT01084759 (3) [back to overview]	Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.
NCT01084759 (3) [back to overview]	Time to PSA Progression
NCT01104246 (1) [back to overview]	Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
NCT01121211 (2) [back to overview]	Change From Baseline in Weight
NCT01121211 (2) [back to overview]	Change From Baseline in Depression Symptom Severity
NCT01127659 (4) [back to overview]	Insulin Sensitivity
NCT01127659 (4) [back to overview]	Insulin Sensitivity
NCT01127659 (4) [back to overview]	Body Composition
NCT01127659 (4) [back to overview]	Body Composition
NCT01143818 (4) [back to overview]	Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score
NCT01143818 (4) [back to overview]	Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score
NCT01143818 (4) [back to overview]	Percent Change From Baseline to Month 6 in Body Mass Index (BMI)
NCT01143818 (4) [back to overview]	Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score
NCT01167829 (10) [back to overview]	Maximum Estradiol Concentration
NCT01167829 (10) [back to overview]	Maximum Testosterone Concentration
NCT01167829 (10) [back to overview]	Free Testosterone Mean Concentration
NCT01167829 (10) [back to overview]	Mean Dihydrotestosterone (DHT) Concentration
NCT01167829 (10) [back to overview]	Mean Testosterone Concentration
NCT01167829 (10) [back to overview]	Mean Estradiol Concentration
NCT01167829 (10) [back to overview]	Mean SHGB Concentration
NCT01167829 (10) [back to overview]	Free T Maximum Concentration
NCT01167829 (10) [back to overview]	Maximum Sex Hormone-Binding Globulin (SHGB)Concentration
NCT01167829 (10) [back to overview]	Maximum Dihydrotestosterone (DHT) Concentration
NCT01201863 (1) [back to overview]	Restricted Functional Independence Measure (FIM)
NCT01208038 (4) [back to overview]	Insulin Resistance - HOMA-IR
NCT01208038 (4) [back to overview]	Endothelial Function
NCT01208038 (4) [back to overview]	Arterial Compliance - Augmentation Index
NCT01208038 (4) [back to overview]	Libido - B-PFSF Score
NCT01215292 (3) [back to overview]	Intratesticular Androstenedione (ADD) Level
NCT01215292 (3) [back to overview]	Intratesticular Dihydrotestosterone (DHT) Level
NCT01215292 (3) [back to overview]	Intratesticular Testosterone (IT-T) Level
NCT01228071 (3) [back to overview]	Time to Target Eugonadal Range
NCT01228071 (3) [back to overview]	Time to Steady State (SS)
NCT01228071 (3) [back to overview]	Gel Drying Time
NCT01252745 (3) [back to overview]	Cavg of Serum Testosterone
NCT01252745 (3) [back to overview]	AUC0-t of Serum Testosterone
NCT01252745 (3) [back to overview]	Cmax of Serum Testosterone
NCT01270841 (4) [back to overview]	Change in FSH After 3 Months of Treatment
NCT01270841 (4) [back to overview]	Change in Luteinizing Hormone Levels
NCT01270841 (4) [back to overview]	Change in Total Morning Testosterone
NCT01270841 (4) [back to overview]	Reproductive Safety
NCT01275365 (10) [back to overview]	Change of Maximal Voluntary Strength
NCT01275365 (10) [back to overview]	Change of Derogatis Affective Balance Scale (DABS)
NCT01275365 (10) [back to overview]	Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)
NCT01275365 (10) [back to overview]	Change of 6-minute Walking Distance
NCT01275365 (10) [back to overview]	Change of 50-meter Loaded Walking Test
NCT01275365 (10) [back to overview]	Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)
NCT01275365 (10) [back to overview]	Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
NCT01275365 (10) [back to overview]	Change of Psychological Well Being Index (PGWBI)
NCT01275365 (10) [back to overview]	Change of Stair Climbing Tests
NCT01275365 (10) [back to overview]	Change of Leg Press Power
NCT01323140 (1) [back to overview]	Percent of Subjects With Testosterone Levels in the Normal Range.
NCT01327495 (14) [back to overview]	Prostate Specific Antigen
NCT01327495 (14) [back to overview]	Prostate Volume
NCT01327495 (14) [back to overview]	Serum Testosterone
NCT01327495 (14) [back to overview]	Progesterone
NCT01327495 (14) [back to overview]	Pregnenolone
NCT01327495 (14) [back to overview]	International Prostate Symptom Score (IPSS)
NCT01327495 (14) [back to overview]	Androsterone
NCT01327495 (14) [back to overview]	DHEA
NCT01327495 (14) [back to overview]	Dihydrotestosterone (DHT)
NCT01327495 (14) [back to overview]	Androstenedione
NCT01327495 (14) [back to overview]	17-OHPreg
NCT01327495 (14) [back to overview]	Prostate Tissue DHT Concentrations After Treatment
NCT01327495 (14) [back to overview]	17-OHP
NCT01327495 (14) [back to overview]	Prostate Tissue Testosterone Concentrations After Treatment
NCT01364623 (5) [back to overview]	Bioavailability (AUC0-t) of Total Testosterone Through Pharmacokinetic (PK) Profiles
NCT01364623 (5) [back to overview]	Area Under the Plasma Concentration Versus Time Curve (AUC) for Dihydrotestosterone Following TBS-2
NCT01364623 (5) [back to overview]	Bioavailability (Cmax) of Total Testosterone Through Pharmacokinetic Profiles
NCT01364623 (5) [back to overview]	Area Under the Plasma Concentration Versus Time Curve (AUC) for Estradiol Following TBS-2
NCT01364623 (5) [back to overview]	Medium Dose TBS-2 Multiple Dose Average Steady-state Concentration (Cavg) of Total Testosterone
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Frequency of Adverse Events (AEs)
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.
NCT01370369 (14) [back to overview]	Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.
NCT01378299 (12) [back to overview]	Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Bone Mineral Density According to Body Mass Index (BMI)
NCT01378299 (12) [back to overview]	Percent Change in Aromatase Gene Activity From the Buffy Coat According to the 700518 Polymorphism of the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus
NCT01378299 (12) [back to overview]	Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Hematocrit According to the Genotype of the 700518 Polymorphism of the CYP19A1gene
NCT01378299 (12) [back to overview]	Percent Change in Hematocrit According to re1062033 Polymorphism of the CYP19A1 Gene
NCT01378299 (12) [back to overview]	Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus
NCT01386606 (7) [back to overview]	Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
NCT01386606 (7) [back to overview]	Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
NCT01386606 (7) [back to overview]	24 Hour Average and Maximum Testosterone Concentration
NCT01386606 (7) [back to overview]	Change in Follicle Stimulating Hormone (FSH)
NCT01386606 (7) [back to overview]	Morning Testosterone Correlated With Serial Testosterone.
NCT01386606 (7) [back to overview]	Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
NCT01386606 (7) [back to overview]	Change in Leuteinizing Hormone (LH)
NCT01403116 (2) [back to overview]	Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL
NCT01403116 (2) [back to overview]	% of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90
NCT01419236 (9) [back to overview]	Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in Ejaculate Volume at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks
NCT01419236 (9) [back to overview]	Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks
NCT01446042 (2) [back to overview]	Serum Testosterone Cavg
NCT01446042 (2) [back to overview]	Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
NCT01460654 (1) [back to overview]	Percent Change in Spine Bone Density From Baseline to 12 Months
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Cmin
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Tmax
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Cmax
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Tmin
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
NCT01464879 (14) [back to overview]	Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
NCT01464879 (14) [back to overview]	Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.
NCT01464879 (14) [back to overview]	Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)
NCT01573442 (14) [back to overview]	Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score
NCT01573442 (14) [back to overview]	Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness)
NCT01573442 (14) [back to overview]	"The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL How Bothered Are You by Hot Flashes"
NCT01573442 (14) [back to overview]	Change in BPI Average Pain From Baseline to Month 1-6
NCT01573442 (14) [back to overview]	Change in Hot Flash Frequency From Baseline to Week 8
NCT01573442 (14) [back to overview]	Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment
NCT01573442 (14) [back to overview]	The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA.
NCT01573442 (14) [back to overview]	The Change of Libido From Baseline to Month 3 as Measured by the MENQOL
NCT01573442 (14) [back to overview]	Number of Patients Who Reported Alopecia Using CTCAE 4.0
NCT01573442 (14) [back to overview]	Number of Patients Who Reported Acne Using CTCAE 4.0
NCT01573442 (14) [back to overview]	Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3
NCT01573442 (14) [back to overview]	Change in BPI Worst Pain From Baseline to Month 3
NCT01573442 (14) [back to overview]	Change in BPI Pain Right Now From Baseline to Month 3
NCT01573442 (14) [back to overview]	Change in BPI Least Pain From Baseline to Month 3
NCT01585831 (10) [back to overview]	Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2
NCT01585831 (10) [back to overview]	Change From Baseline on the Conners Parent Rating Scales: Anxiety
NCT01585831 (10) [back to overview]	Change From Baseline on the Wechsler Intelligence Scale for Children - Fourth Edition
NCT01585831 (10) [back to overview]	Change From Baseline on the Vineland Adaptive Behavior Scales - 2nd Edition
NCT01585831 (10) [back to overview]	Change From Baseline on the Comprehensive Test of Phonological Processing
NCT01585831 (10) [back to overview]	Change From Baseline on the Delis-Kaplan Executive Function System
NCT01585831 (10) [back to overview]	Change From Baseline on the Conners Parent Rating Scales: Social Skills
NCT01585831 (10) [back to overview]	Change From Baseline on the Conners Parent Rating Scales: Emotional Lability
NCT01585831 (10) [back to overview]	Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity
NCT01585831 (10) [back to overview]	Change From Baseline on the Conners Parent Rating Scales: DSM Attention
NCT01595581 (3) [back to overview]	Strength
NCT01595581 (3) [back to overview]	KOOS Scores
NCT01595581 (3) [back to overview]	Changes in Lean Mass
NCT01652040 (2) [back to overview]	Metabolic Profile
NCT01652040 (2) [back to overview]	Body Composition
NCT01665599 (17) [back to overview]	Pharmacokinetics of DHT Measuring Tmin
NCT01665599 (17) [back to overview]	Pharmacokinetics of DHT Measuring Tmax
NCT01665599 (17) [back to overview]	The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
NCT01665599 (17) [back to overview]	Pharmacokinetics of DHT Measuring Cmin
NCT01665599 (17) [back to overview]	Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
NCT01665599 (17) [back to overview]	The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
NCT01665599 (17) [back to overview]	Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
NCT01665599 (17) [back to overview]	Change From Baseline in the SF-12 Health Questionnaire
NCT01665599 (17) [back to overview]	Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
NCT01665599 (17) [back to overview]	Pharmacokinetics of DHT Measuring Cave
NCT01665599 (17) [back to overview]	Pharmacokinetics of DHT Measuring Cmax
NCT01665599 (17) [back to overview]	Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
NCT01665599 (17) [back to overview]	Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
NCT01665599 (17) [back to overview]	Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
NCT01665599 (17) [back to overview]	Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
NCT01665599 (17) [back to overview]	Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
NCT01665599 (17) [back to overview]	Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
NCT01686828 (3) [back to overview]	Insulin Sensitivity Quantified by Matsuda Index
NCT01686828 (3) [back to overview]	Changes in Adipose Tissue Gene Expression
NCT01686828 (3) [back to overview]	Changes in Body Composition
NCT01697345 (8) [back to overview]	FSFI Pain Domain
NCT01697345 (8) [back to overview]	FSFI Orgasm Domain
NCT01697345 (8) [back to overview]	FSFI Arousal Domain
NCT01697345 (8) [back to overview]	FSFI Desire Domain
NCT01697345 (8) [back to overview]	FSFI Lubrication Domain
NCT01697345 (8) [back to overview]	FSFI Satisfaction Domain
NCT01697345 (8) [back to overview]	Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study
NCT01697345 (8) [back to overview]	Total Female Sexual Function Index (FSFI) Score
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in Hct
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in Prostate Volume
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in T Cholesterol
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in LDL
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in Hgb
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in HDL
NCT01703741 (13) [back to overview]	Domain Scores for the Short Form-12 (SF-12) Questionnaire
NCT01703741 (13) [back to overview]	Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire
NCT01703741 (13) [back to overview]	Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire
NCT01703741 (13) [back to overview]	Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
NCT01703741 (13) [back to overview]	Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
NCT01703741 (13) [back to overview]	Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.
NCT01703741 (13) [back to overview]	Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire
NCT01703741 (13) [back to overview]	Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone
NCT01703741 (13) [back to overview]	Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
NCT01703741 (13) [back to overview]	Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
NCT01703741 (13) [back to overview]	Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
NCT01703741 (13) [back to overview]	Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
NCT01703741 (13) [back to overview]	Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
NCT01717768 (4) [back to overview]	Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment
NCT01717768 (4) [back to overview]	Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002
NCT01717768 (4) [back to overview]	AUC 0-24 Hrs After 120 mg Dose of TSX-002
NCT01717768 (4) [back to overview]	Cavg 0-24 Hrs (ng/dL) After 120 mg Dose
NCT01725451 (2) [back to overview]	Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone
NCT01725451 (2) [back to overview]	Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
NCT01750398 (7) [back to overview]	Patients With PSA <4 ng/mL at the End of the Study
NCT01750398 (7) [back to overview]	Change in C-telopeptides
NCT01750398 (7) [back to overview]	Radiographic or Clinical Progression
NCT01750398 (7) [back to overview]	Quality of Life Survey
NCT01750398 (7) [back to overview]	Complete PSA Response
NCT01750398 (7) [back to overview]	Change in Weight
NCT01750398 (7) [back to overview]	Change in Waist Circumference
NCT01765179 (2) [back to overview]	Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
NCT01765179 (2) [back to overview]	Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
NCT01783574 (3) [back to overview]	Depressive Symptom Severity
NCT01783574 (3) [back to overview]	Sexual Dysfunction
NCT01783574 (3) [back to overview]	Fatigue
NCT01816295 (5) [back to overview]	Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
NCT01816295 (5) [back to overview]	Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
NCT01816295 (5) [back to overview]	Change From Baseline in Total International Prostate Symptom Score (IPSS)
NCT01816295 (5) [back to overview]	Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores
NCT01816295 (5) [back to overview]	Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores
NCT01873989 (3) [back to overview]	Change in Pain Ratings
NCT01873989 (3) [back to overview]	Number of Participants Demonstrating Abstinence
NCT01873989 (3) [back to overview]	Change in Sexual Dysfunction From Baseline to Week 8
NCT01887418 (4) [back to overview]	The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
NCT01887418 (4) [back to overview]	The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
NCT01887418 (4) [back to overview]	The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
NCT01887418 (4) [back to overview]	Number of Patients in the PK Parameter Category
NCT01893281 (4) [back to overview]	Change From Baseline in Serum Testosterone Levels
NCT01893281 (4) [back to overview]	Percentage of Participants Achieving Normal Serum Testosterone Levels
NCT01893281 (4) [back to overview]	Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
NCT01893281 (4) [back to overview]	Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
NCT01909141 (5) [back to overview]	Pregnancy Rate
NCT01909141 (5) [back to overview]	Number of Follicles>18mm.
NCT01909141 (5) [back to overview]	Endometrial Thickness
NCT01909141 (5) [back to overview]	Ovulation Rate
NCT01909141 (5) [back to overview]	Safety of Pioglitazone as Regards Serum Creatinine
NCT02004132 (3) [back to overview]	Amount of Testosterone Following Laundering
NCT02004132 (3) [back to overview]	Amount of Testosterone on T-shirts
NCT02004132 (3) [back to overview]	Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts
NCT02090114 (10) [back to overview]	Disease Response as Defined by RECIST 1.1 (Soft Tissue Lesions) and PCWG2 Criteria (Bone Lesions)
NCT02090114 (10) [back to overview]	Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy (BAT)
NCT02090114 (10) [back to overview]	PSA Progression on BAT (Bipolar Androgen Therapy )
NCT02090114 (10) [back to overview]	PSA Progression on Enzalutamide or Abiraterone Acetate or Castrate Levels Post-BAT
NCT02090114 (10) [back to overview]	PSA Response to Enzalutamide or Abiraterone Acetate Post Bipolar Androgen Therapy
NCT02090114 (10) [back to overview]	Safety and Tolerability as Assessed by Number of Participants With Adverse Events
NCT02090114 (10) [back to overview]	Quality of Life (QoL) as Assessed by FACIT-F Score
NCT02090114 (10) [back to overview]	Quality of Life (QoL) as Assessed by IIEF
NCT02090114 (10) [back to overview]	Quality of Life (QoL) as Assessed by PANAS
NCT02090114 (10) [back to overview]	Quality of Life (QoL) as Assessed by RANDSF-36
NCT02149264 (10) [back to overview]	Change From Baseline in International Index of Erectile Function (IIEF) Score
NCT02149264 (10) [back to overview]	The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
NCT02149264 (10) [back to overview]	Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
NCT02149264 (10) [back to overview]	Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
NCT02149264 (10) [back to overview]	Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
NCT02149264 (10) [back to overview]	Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
NCT02149264 (10) [back to overview]	Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
NCT02149264 (10) [back to overview]	Change From Baseline in Short Form-12 Health Survey (SF-12) Score
NCT02149264 (10) [back to overview]	Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
NCT02149264 (10) [back to overview]	The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
NCT02159469 (2) [back to overview]	Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
NCT02159469 (2) [back to overview]	Safety and Tolerability
NCT02222558 (1) [back to overview]	Percentage of Responders
NCT02233751 (7) [back to overview]	Time to Maximum Concentration (Tmax)(hr)
NCT02233751 (7) [back to overview]	Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
NCT02233751 (7) [back to overview]	Half-life (t 1/2)(hr)
NCT02233751 (7) [back to overview]	Clearance CL/F (L/hr)
NCT02233751 (7) [back to overview]	Vd/F (L)
NCT02233751 (7) [back to overview]	Area Under the Concentration-time Curve From Time Zero to Infinity
NCT02233751 (7) [back to overview]	Area Under the Concentration-time Curve From Time Zero to Time t
NCT02248701 (6) [back to overview]	Percent Change in Visceral Fat
NCT02248701 (6) [back to overview]	Percent Changes in Muscle Cross-Sectional Area
NCT02248701 (6) [back to overview]	Percent Change in Total Body Fat
NCT02248701 (6) [back to overview]	Percent Change in Neuromuscular Function
NCT02248701 (6) [back to overview]	Percent Change in Hip Bone Mineral Density
NCT02248701 (6) [back to overview]	Absolute Change in Walking Speed
NCT02286921 (14) [back to overview]	Quality of Life as Assessed by FACIT Fatigue Scale
NCT02286921 (14) [back to overview]	Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression
NCT02286921 (14) [back to overview]	Progression Free Survival on Crossover Treatment
NCT02286921 (14) [back to overview]	Prostate-Specific Antigen Response Rate
NCT02286921 (14) [back to overview]	Radiographic Progression
NCT02286921 (14) [back to overview]	Time to Prostate-Specific Antigen Progression
NCT02286921 (14) [back to overview]	Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)
NCT02286921 (14) [back to overview]	Objective Response Rate as Determined by RECIST
NCT02286921 (14) [back to overview]	Overall Survival
NCT02286921 (14) [back to overview]	Quality of Life as Assessed by Short Form 36
NCT02286921 (14) [back to overview]	Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
NCT02286921 (14) [back to overview]	Pain Interference as Assessed by the Brief Pain Inventory
NCT02286921 (14) [back to overview]	Pain Severity as Assessed by the Brief Pain Inventory
NCT02286921 (14) [back to overview]	Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)
NCT02367105 (45) [back to overview]	Change in Static Balance
NCT02367105 (45) [back to overview]	Change in Symbol Digital Modalities Test
NCT02367105 (45) [back to overview]	Change in the Physical Performance Test
NCT02367105 (45) [back to overview]	Change in Thigh Muscle Volume
NCT02367105 (45) [back to overview]	Change in Total Hip Bone Mineral Density
NCT02367105 (45) [back to overview]	Change in Total Testosterone Levels
NCT02367105 (45) [back to overview]	Change in Trabecular Bone Score (Trabecular Bone Quality)
NCT02367105 (45) [back to overview]	Change in Trail A
NCT02367105 (45) [back to overview]	Change in Trail B
NCT02367105 (45) [back to overview]	Change in Triglyceride Levels
NCT02367105 (45) [back to overview]	Change in Waist Circumference
NCT02367105 (45) [back to overview]	Change in Word List Fluency
NCT02367105 (45) [back to overview]	Stroop Interference
NCT02367105 (45) [back to overview]	Thigh Fat Volume
NCT02367105 (45) [back to overview]	Number of Participants With Significant Changes in Functional Connectivity in the Default Mode Network
NCT02367105 (45) [back to overview]	Change in Trabecular Bone Score
NCT02367105 (45) [back to overview]	Change in Body Weight
NCT02367105 (45) [back to overview]	Change in C-terminal Telopeptide
NCT02367105 (45) [back to overview]	Change in Composite Cognitive Z-score
NCT02367105 (45) [back to overview]	Change in Dynamic Balance
NCT02367105 (45) [back to overview]	Change in Endurance Capacity
NCT02367105 (45) [back to overview]	Change in Estradiol
NCT02367105 (45) [back to overview]	Change in Fat Mass
NCT02367105 (45) [back to overview]	Change in Functional Status
NCT02367105 (45) [back to overview]	Change in Gait Speed
NCT02367105 (45) [back to overview]	Change in Glucose
NCT02367105 (45) [back to overview]	Change in HDL-cholesterol
NCT02367105 (45) [back to overview]	Change in Hematocrit
NCT02367105 (45) [back to overview]	Change in High-sensitivity C-reactive Protein (Inflammatory Marker)
NCT02367105 (45) [back to overview]	Change in Insulin Growth Factor-1
NCT02367105 (45) [back to overview]	Change in Interleukin-6
NCT02367105 (45) [back to overview]	Change in International Prostate Symptom Score
NCT02367105 (45) [back to overview]	Change in Lean Body Mass
NCT02367105 (45) [back to overview]	Change in Levels of 25-hydroxyvitamin D
NCT02367105 (45) [back to overview]	Change in Lumbar Spine Bone Mineral Density
NCT02367105 (45) [back to overview]	Change in Modified Mini-mental Exam
NCT02367105 (45) [back to overview]	Change in Mood
NCT02367105 (45) [back to overview]	Change in Muscle Strength
NCT02367105 (45) [back to overview]	Change in N-terminal Propeptide of Type I Procollagen
NCT02367105 (45) [back to overview]	Change in Parathyroid Hormone Level
NCT02367105 (45) [back to overview]	Change in Peripheral Quantitative Computed Tomography Measures (Volumetric Bone Density)
NCT02367105 (45) [back to overview]	Change in Prostate Specific Antigen
NCT02367105 (45) [back to overview]	Change in Ray Auditory Verbal Learning Test
NCT02367105 (45) [back to overview]	Change in Short Form Health Survey (SF-36) Quality of Life Physical Component
NCT02367105 (45) [back to overview]	Change in Skeletal Muscle Growth Factor (MYOD1)
NCT02408445 (10) [back to overview]	Serum Follicle Stimulating Hormone (FSH)
NCT02408445 (10) [back to overview]	Serum Total Testosterone
NCT02408445 (10) [back to overview]	Serum Luteinizing Hormone (LH)
NCT02408445 (10) [back to overview]	Serum Inhibin B (INHB)
NCT02408445 (10) [back to overview]	Serum Anti-Mullerian Hormone (AMH)
NCT02408445 (10) [back to overview]	Change in Total Motor Standard Score on the Peabody Developmental Motor Scales 2
NCT02408445 (10) [back to overview]	Change in Raw Score on the Alberta Infant Motor Scale
NCT02408445 (10) [back to overview]	Change in Penile Length
NCT02408445 (10) [back to overview]	Change in Fat Free Mass
NCT02408445 (10) [back to overview]	Change in Body Fat Percent Z-score
NCT02504541 (1) [back to overview]	Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
NCT02513940 (5) [back to overview]	Area Under the QTF Versus Time Curve for 0-1 Hour Following Ibutilide 0.003 mg/kg
NCT02513940 (5) [back to overview]	Maximum QTF Following Ibutilide 0.003 mg/kg
NCT02513940 (5) [back to overview]	Number of Participants With Adverse Effects Associated With Testosterone, Progesterone and Placebo
NCT02513940 (5) [back to overview]	Baseline (Pre-ibutilide) Individualized Rate-corrected QT Interval (QTF)
NCT02513940 (5) [back to overview]	Maximum Percent Change From Pretreatment Value in QTF Following Ibutilide 0.003 mg/kg
NCT02611154 (3) [back to overview]	Testosterone Level in Blood as Measured for Safety
NCT02611154 (3) [back to overview]	Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline
NCT02611154 (3) [back to overview]	Steroid Levels in Urine Steroid Profile
NCT02670343 (1) [back to overview]	% of Mean Difference in T Concentration Compared to Plain Collection Tube
NCT02679274 (13) [back to overview]	Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
NCT02679274 (13) [back to overview]	Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
NCT02679274 (13) [back to overview]	Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks.
NCT02679274 (13) [back to overview]	Change in Knee Extension Strength (Seated)
NCT02679274 (13) [back to overview]	Change in Hip Abduction Strength (Supine)
NCT02679274 (13) [back to overview]	Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
NCT02679274 (13) [back to overview]	Change in Handgrip Strength
NCT02679274 (13) [back to overview]	Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline
NCT02679274 (13) [back to overview]	Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
NCT02679274 (13) [back to overview]	Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
NCT02679274 (13) [back to overview]	Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
NCT02679274 (13) [back to overview]	Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB).
NCT02679274 (13) [back to overview]	Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)
NCT02697188 (2) [back to overview]	Mean Serum Testosterone Cavg
NCT02697188 (2) [back to overview]	Mean Serum Dihydrotestosterone Cmax
NCT02722278 (2) [back to overview]	Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8
NCT02722278 (2) [back to overview]	Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7
NCT02734238 (1) [back to overview]	Body Composition at the End of Each Study Phase
NCT02777242 (1) [back to overview]	Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
NCT02921386 (4) [back to overview]	Cmax-am for Oral TU Across Breakfast With Varying Fat Content
NCT02921386 (4) [back to overview]	Area Under the Curve (AUC-am)
NCT02921386 (4) [back to overview]	Time Weighted Average Total Testosterone Concentration (Cavg-am)
NCT02921386 (4) [back to overview]	Time of Peak Concentration (Tmax-am)
NCT02937740 (2) [back to overview]	Patient Satisfaction - Change From Baseline
NCT02937740 (2) [back to overview]	Change in Hypogonadism Symptoms
NCT03091348 (8) [back to overview]	Change in Levels of Serum LH
NCT03091348 (8) [back to overview]	Change in Levels of Serum SHBG
NCT03091348 (8) [back to overview]	Change in Levels of Serum FSH
NCT03091348 (8) [back to overview]	Change in Levels of Serum Estradiol
NCT03091348 (8) [back to overview]	Change in Levels of Whole Blood Hematocrit
NCT03091348 (8) [back to overview]	Change in Levels of Serum Calculated Free T Concentration
NCT03091348 (8) [back to overview]	Change in Level of Serum PSA
NCT03091348 (8) [back to overview]	Change in Levels of Serum Total Testosterone Concentration
NCT03123913 (8) [back to overview]	Mean Change in Level of FSH in the Blood
NCT03123913 (8) [back to overview]	Mean Change in Level of IGF-1 in the Blood
NCT03123913 (8) [back to overview]	Number of Participants Who Experienced an AE
NCT03123913 (8) [back to overview]	Mean Change in Total Lean Body Mass
NCT03123913 (8) [back to overview]	Mean Change in Level of TSH in the Blood
NCT03123913 (8) [back to overview]	Mean Change in Level of Total Testosterone in the Blood
NCT03123913 (8) [back to overview]	Mean Change in Level of Free Testosterone in the Blood
NCT03123913 (8) [back to overview]	Mean Change in Level of Luteinizing Hormone in the Blood
NCT03198728 (18) [back to overview]	Effect of SOV2012-F1 on Adrenal Cortical Function as Assessed by Measuring the Cortisol Response to Synthetic ACTH at Baseline in Subjects
NCT03198728 (18) [back to overview]	Percentages of Participants in Each Category for Maximum Plasma Concentration
NCT03198728 (18) [back to overview]	Change in Bilirubin
NCT03198728 (18) [back to overview]	Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1.
NCT03198728 (18) [back to overview]	Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
NCT03198728 (18) [back to overview]	Change From Baseline in Fasting Insulin Concentration
NCT03198728 (18) [back to overview]	Change From Baseline in Fasting Serum Glucose (FSG) Concentration
NCT03198728 (18) [back to overview]	Change From Baseline in Hematology Parameters
NCT03198728 (18) [back to overview]	Change From Baseline in Hormone Levels
NCT03198728 (18) [back to overview]	Change From Baseline in Lipid Profiles
NCT03198728 (18) [back to overview]	Change From Baseline in Liver Function Tests
NCT03198728 (18) [back to overview]	Change From Baseline in PSA
NCT03198728 (18) [back to overview]	Change From Baseline in the IIEF
NCT03198728 (18) [back to overview]	Change From Baseline in the IPSS
NCT03198728 (18) [back to overview]	Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
NCT03198728 (18) [back to overview]	Change From Baseline in the SF-36
NCT03198728 (18) [back to overview]	Change in Hormone SHBG
NCT03198728 (18) [back to overview]	Change in TSH (Thyrotropin)
NCT03203681 (6) [back to overview]	Change in Sperm Counts From Baseline to 27 Weeks
NCT03203681 (6) [back to overview]	Change in Estradiol Levels From Baseline to 27 Weeks
NCT03203681 (6) [back to overview]	Change in Testosterone Levels From Baseline to 27 Weeks
NCT03203681 (6) [back to overview]	Number of Participants With an Increase in SF-36 QOL Scores From Baseline
NCT03203681 (6) [back to overview]	Change in Gonadotropin Levels From Baseline to 27 Weeks
NCT03203681 (6) [back to overview]	Incidence of Adverse Events
NCT03242408 (1) [back to overview]	Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
NCT03242590 (1) [back to overview]	Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range
NCT03516812 (2) [back to overview]	Radiographic Response Rate
NCT03516812 (2) [back to overview]	Percent of Patients With a Prostate-specific Antigen (PSA) Decline of at Least 50% Below Baseline PSA50 Response Rate
NCT03554317 (7) [back to overview]	Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]	Safety of Bipolar Androgen Therapy + Nivolumab As Determined by the Number of CTCAEs ≥ Grade 3
NCT03554317 (7) [back to overview]	Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]	Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]	Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]	Progression-Free Survival (PFS) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]	PSA Progression-Free Survival (PSA-PFS) to Bipolar Androgen Therapy + Nivolumab
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average Nighttime PR
NCT03868059 (26) [back to overview]	Change is SBP Dip
NCT03868059 (26) [back to overview]	Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%
NCT03868059 (26) [back to overview]	Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average Nighttime SBP
NCT03868059 (26) [back to overview]	Change in Hemoglobin From Baseline
NCT03868059 (26) [back to overview]	Change in Hematocrit From Baseline
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg
NCT03868059 (26) [back to overview]	Change in Morning DBP Measured in Triplicate at the Clinic
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)
NCT03868059 (26) [back to overview]	Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
NCT03868059 (26) [back to overview]	Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
NCT03868059 (26) [back to overview]	Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose
NCT03868059 (26) [back to overview]	Change in Patient Reported Sexual Desire
NCT03868059 (26) [back to overview]	Change in Morning PR Measured in Triplicate at the Clinic
NCT03868059 (26) [back to overview]	Change in Morning SBP Measured in Triplicate at the Clinic
NCT03868059 (26) [back to overview]	Change in Patient Reported Sexual Distress
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour Pulse Rate (PR)
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average Daytime DBP
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average Daytime PR
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average Daytime SBP
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average Nighttime DBP
NCT03868059 (26) [back to overview]	Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
NCT04120363 (6) [back to overview]	Wingate Peak Power
NCT04120363 (6) [back to overview]	Vertical Jump Height
NCT04120363 (6) [back to overview]	Total Mass Lifted
NCT04120363 (6) [back to overview]	Peak Aerobic Capacity
NCT04120363 (6) [back to overview]	Load Carriage Time
NCT04120363 (6) [back to overview]	Body Composition
NCT04134091 (13) [back to overview]	Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	Relative Change in Whole Body Fat Mass
NCT04134091 (13) [back to overview]	Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	Relative Change in Appendicular Lean Muscle Mass
NCT04134091 (13) [back to overview]	Number of Subjects Achieving Resolution of NASH on Overall Histopathological Reading and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	Number of Participants With Resolution of NASH on Overall Histopathological Reading in LPCN 1144 Treated Subjects Compared to Placebo
NCT04134091 (13) [back to overview]	Number of Subjects With an Improvement in Liver Fibrosis Greater Than or Equal to One Stage and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	Number of Subjects With Improvement in Fibrosis Evaluated by Paired Biopsies Analysis and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo
NCT04134091 (13) [back to overview]	Number of Subjects With Improvement in Fibrosis Evaluated Via FibroNest Scores
NCT04134091 (13) [back to overview]	Number of Subjects With Improvement in NASH Evaluated by Paired Biopsies Analysis and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	Mean Change From Baseline in Liver Enzymes in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04274894 (1) [back to overview]	Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)
NCT04320745 (5) [back to overview]	Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16
NCT04320745 (5) [back to overview]	Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16
NCT04320745 (5) [back to overview]	Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16
NCT04320745 (5) [back to overview]	Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16
NCT04320745 (5) [back to overview]	Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16
NCT04439799 (5) [back to overview]	Change in Hormone Levels
NCT04439799 (5) [back to overview]	Changes in IIEF-6 Score
NCT04439799 (5) [back to overview]	Change in PSA Levels
NCT04439799 (5) [back to overview]	Change in Hematocrit (Hct) Levels.
NCT04439799 (5) [back to overview]	Change in Estradiol Levels
NCT04523480 (4) [back to overview]	Change in Estradiol Levels
NCT04523480 (4) [back to overview]	Change in Hematocrit (Hct) Levels.
NCT04523480 (4) [back to overview]	Change in PSA Levels
NCT04523480 (4) [back to overview]	Change in Testosterone (T) Levels
NCT04983940 (6) [back to overview]	Serum Testosterone Levels
NCT04983940 (6) [back to overview]	PSA Levels Measured in ng/mL
NCT04983940 (6) [back to overview]	Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain)
NCT04983940 (6) [back to overview]	Hematocrit Levels
NCT04983940 (6) [back to overview]	Serum Estradiol Levels
NCT04983940 (6) [back to overview]	Hypogonadal Symptoms as Measured by qADAM Questionnaire

MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.

Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia (NCT00080483)
Timeframe: baseline, one year, two years

Intervention	unitless (Mean)
	baseline	one year	two years
1 The Effects of Testosterone Combined With G	0.112	0.119	0.123
2 The Effects of Testosterone Alone on Structural and Mechanic	0.104	0.111	0.114

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Markers of Bone Metabolism

type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change. (NCT00089843)
Timeframe: Baseline to 12 months

Intervention	percent change of CTX (Mean)
Actonel (Risedronate)	-41
Testosterone	-11

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Bone Mineral Density

Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change. (NCT00089843)
Timeframe: Baseline and 12 months

Intervention	percent change (Mean)
Actonel (Risedronate) 35 mg Weekly	3.2
Testosterone	-0.6

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Safety: Number of Subjects Reporting a Skin Reaction to the Patch

Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant. (NCT00095212)
Timeframe: Baseline (time 0) to 18 months

Intervention	participants (Number)
Transdermal Testosterone (Patch)	4
Placebo Patch (Identical in Appearance)	1

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Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)

Intervention	participants (Number)
Transdermal Testosterone (Patch)	6
Placebo Patch (Identical in Appearance)	9

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Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)

Intervention	participants (Number)
Transdermal Testosterone (Patch)	2
Placebo Patch (Identical in Appearance)	4

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Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function

Represents change in measure from baseline to 18 months. The BISF is 22 items with seven domains: Thoughts and Desires, Arousal, Frequency of Sexual Activity, Receptivity/Initiation, Pleasure, Relationship Satisfaction, and Problems Affecting Sexual Function. Data from Domain 7: Problems Affecting Sexual Function is reported. The score range for this domain is -16 to 75,a higher score indicates greater sexual function. (NCT00095212)
Timeframe: Baseline (time 0) to 18 months

Intervention	Units on a scale (Mean)
Transdermal Testosterone (Patch)	-1.8
Placebo Patch (Identical in Appearance)	0.5

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Quality of Life/Depression: Becks Depression Inventory

Represents change in the mean score from baseline to 18 months. Depression was evaluated with the Beck's Depression Inventory (BDI). The BDI is a 21-item self-report instrument used to assess the presence and severity of symptoms of depression. A Total score in the range of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00095212)
Timeframe: Baseline (time 0) to 18 months

Intervention	Units on a scale (Mean)
Transdermal Testosterone (Patch)	-6.8
Placebo Patch (Identical in Appearance)	-1.9

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Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.

Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds. (NCT00095212)
Timeframe: Baseline (time 0) to 18 months

Intervention	kilograms (Mean)
Transdermal Testosterone (Patch)	28.5
Placebo Patch (Identical in Appearance)	11.0

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Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.

Intervention	kilograms (Mean)
Transdermal Testosterone (Patch)	28.0
Placebo Patch (Identical in Appearance)	26.9

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Safety: Number of Subjects Reporting Acne

Intervention	participants (Number)
Transdermal Testosterone (Patch)	4
Placebo Patch (Identical in Appearance)	3

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Lean Body Mass

Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan. (NCT00095212)
Timeframe: Baseline (time 0) to 18 months

Intervention	kilograms (Mean)
Transdermal Testosterone (Patch)	1.8
Placebo Patch (Identical in Appearance)	0.8

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Bone Mineral Density of the Hip

Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for bone mineral density of the hip measured by dual energy absorptiometry (DEXA)scan. (NCT00095212)
Timeframe: Baseline (time 0) to 18 months

Intervention	grams per centimeter squared (Mean)
Transdermal Testosterone (Patch)	0.01
Placebo Patch (Identical in Appearance)	-0.01

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"Neurocognitive Function: Hopkins Verbal Learning Test-revised,Total Recall Z Score Represents Change in Z Score From Baseline to 18 Months."

This test assesses verbal learning and memory. Subjects are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate trials. The Total Recall Z score is calculated based on the sum of total correct responses for Trials 1,2,& 3. A Z score of 0 equals the 50 percentile, a Z score of 1 is 1 standard deviation above the mean and a Z score of -1 is 1 standard deviation below the mean. The lowest and highest T scores for the HVLT-R are ≤20 and ≥80. This correlates to lowest and highest Z scores of ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor recall. (NCT00095212)
Timeframe: Baseline (time 0) to 18 months

Intervention	Units on a scale (Mean)
Transdermal Testosterone (Patch)	-0.21
Placebo Patch (Identical in Appearance)	0.50

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Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release

Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo (NCT00104572)
Timeframe: 1 year

Intervention	ng/ml/8h (Mean)
Transdermal Testosterone	5.8
Aromatase Inhibitor	10
Placebo	7.7

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Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function

"rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo.~Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point." (NCT00104572)
Timeframe: 1 year

Intervention	cc (Mean)
Transdermal Testosterone	4.5
Aromatase Inhibitor	-1.66
Placebo	-1.05

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Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density

bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo (NCT00104572)
Timeframe: 1 year

Intervention	g/cm2 (Mean)
Transdermal Testosterone	0.042
Aromatase Inhibitor	0.008
Placebo	0.047

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Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism

"Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more.~Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point." (NCT00104572)
Timeframe: 1 year

Intervention	score on a scale (Mean)
Transdermal Testosterone	-0.05
Aromatase Inhibitor	0.15
Placebo	-0.11

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Lower Body Muscle Strength (1-RM, kg)

The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented. (NCT00112151)
Timeframe: Baseline and 12 months

Intervention	kg (Mean)
Placebo + No PRT	9.4
Placebo + PRT	27.0
Any T + No PRT	10.5
Any T + PRT	28.0

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Fat Free Mass (kg)

Total change in Fat free mass (kg) as evaluated by DXA (NCT00112151)
Timeframe: Baseline and 12 months

Intervention	kg (Mean)
Placebo + No PRT	0.1
Placebo + PRT	0.4
Any T + No PRT	1.0
Any T + PRT	2.1

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Physical Function (CS-PFP Total Score)

Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function. (NCT00112151)
Timeframe: Baseline and 12 months

Intervention	units on a scale (Mean)
Placebo + No PRT	3.1
Placebo + PRT	3.6
Any T + No PRT	0.8
Any T + PRT	3.3

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Fat Mass (kg)

Total change in Fat mass (kg) as evaluated by DXA (NCT00112151)
Timeframe: Baseline and 12 months

Intervention	kg (Mean)
Placebo + No PRT	0.7
Placebo + PRT	-0.6
Any T + No PRT	-1.0
Any T + PRT	-1.8

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Power (Power Rig, Watts)

Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts). (NCT00112151)
Timeframe: Baseline and 12 months

Intervention	Watts (Mean)
Placebo + No PRT	4.5
Placebo + PRT	24.3
Any T + No PRT	0.8
Any T + PRT	5.1

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Upper Body Muscle Strength (1-RM, kg)

The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented. (NCT00112151)
Timeframe: Baseline and 12 months

Intervention	kg (Mean)
Placebo + No PRT	4.3
Placebo + PRT	25.5
Any T + No PRT	7.8
Any T + PRT	24.3

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Change in Erectile Function Symptoms

Based on International Index of Erectile Function (IIEF) scale, question #15, which asked subjects to rate their confidence that they could achieve and maintain an erection. Scores range from 1 to 5, with higher scores being better. (NCT00114114)
Timeframe: Baseline and 16 weeks

Intervention	units on a scale (Mean)
Group 1: 0 g/Day	-1.4
Group 2: 1.25 g/Day	-0.5
Group 3: 2.5 g/Day	-0.2
Group 4: 5 g/Day	-0.1
Group 5: 10* g/Day	0.2
Group 6: PBO/PBO	-0.3

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Change in Libido / Sexual Desire

Change in libido from baseline (scale ranges from -2 to +2), with -2 being much less, -1 somewhat less, 0 same, +1 somewhat more, +2 much more (NCT00114114)
Timeframe: 16 weeks

Intervention	units on a scale (Mean)
Group 1: 0 g/Day	-1.6
Group 2: 1.25 g/Day	-0.6
Group 3: 2.5 g/Day	-0.6
Group 4: 5 g/Day	-0.2
Group 5: 10* g/Day	0
Group 6: PBO/PBO	-0.3

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Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)

(NCT00114114)
Timeframe: Baseline and 16 weeks

Intervention	percentage change (Mean)
Group 1: 0 g/Day	103
Group 2: 1.25 g/Day	41
Group 3: 2.5 g/Day	29
Group 4: 5 g/Day	15
Group 5: 10* g/Day	4
Group 6: Placebo/Placebo (PBO/PBO)	11

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Percentage Change in Body Composition: Fat Mass

(NCT00114114)
Timeframe: Baseline and 16 weeks

Intervention	Percentage change (Mean)
Group 1: 0 g/Day	9.8
Group 2: 1.25 g/Day	5.7
Group 3: 2.5 g/Day	1.9
Group 4: 5 g/Day	0.4
Group 5: 10* g/Day	-1.6
Group 6: PBO/PBO	2.3

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Percentage Change in Thigh Muscle Area

Assessed by quantitative computed tomography (QCT) (NCT00114114)
Timeframe: Baseline and 16 weeks

Intervention	percentage change (Mean)
Group 1: 0 g/Day	-1.5
Group 2: 1.25 g/Day	-1.6
Group 3: 2.5 g/Day	-0.4
Group 4: 5 g/Day	-0.5
Group 5: 10* g/Day	0.5
Group 6: PBO/PBO	-0.9

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Fatigue Impact Scale

change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated (NCT00144391)
Timeframe: 6 months

Intervention	units on a scale (Mean)
Transdermal Testosterone Gel	-22.9
Placebo	2.2

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Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.

(NCT00194675)
Timeframe: Baseline, 3-months, 6-months

Intervention	ng/ dL (Mean)
	Total testosterone, baseline	Total testosterone, month 3	Total testosterone, month 6	Free testosterone, baseline	Free testosterone, month 3	Free testosterone, month 6	Dihydrotestosterone (DHT), baseline	Dihydrotestosterone (DHT), month 3	Dihydrotestosterone (DHT), month 6	Dehydroepiandrosterone (DHEA), baseline	Dehydroepiandrosterone (DHEA), month 3	Dehydroepiandrosterone (DHEA), month 6	Androstenedione, baseline	Androstenedione, month 3	Androstenedione, month 6
Testosterone Gel + Oral Dutasteride	213	525	534	4.5	12.0	12.3	28	16	12	99	109	111	47	140	123
Testosterone Gel + Oral Placebo	206	494	481	4.2	11.3	11.4	47	145	134	72	98	97	45	99	100

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Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.

(NCT00194675)
Timeframe: Baseline, Month 6

Intervention	cubic centimeters (Mean)
	Baseline, Day 0	Month 6
Testosterone Gel + Oral Dutasteride	44.4	38.6
Testosterone Gel + Oral Placebo	54.2	58.3

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Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)

(NCT00194675)
Timeframe: Baseline, Month 6

Intervention	ng/ ml (Mean)
	Baseline PSA	Month 6 PSA
Testosterone Gel + Oral Dutasteride	2.1	1.4
Testosterone Gel + Oral Placebo	2.8	3.1

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Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume

(NCT00194675)
Timeframe: Baseline, 3-months, 6-months

Intervention	cc (Mean)
	Baseline Post Residual Volume (PVR)	3 month Post Residual Volume	6 month Post Residual Volume
Testosterone Gel + Oral Dutasteride	48	41	32
Testosterone Gel + Oral Placebo	43	36	39

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Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)

(NCT00194675)
Timeframe: Baseline, 3-months, 6-months

Intervention	cc/sec (Mean)
	Baseline Uroflow, Baseline	Uroflow after 3 months of treatment	Uroflow after 6 months of treatment
Testosterone Gel + Oral Dutasteride	13.4	13.2	14.6
Testosterone Gel + Oral Placebo	13.8	12.7	13.8

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The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)

International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales. (NCT00194675)
Timeframe: Baseline, Month 3, Month 6

Intervention	score (Mean)
	Baseline IPSS	Month 3- IPSS	Month 6 IPSS
Testosterone Gel + Oral Dutasteride	13.3	10.2	10.3
Testosterone Gel + Oral Placebo	13.5	11.6	11.1

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Myocardial Perfusion

"Myocardial perfusion (blood flow in the heart muscle) in subendocardial myocardial segments (one of the inner layers of heart muscle), supplied by coronary arteries without significant obstruction. This was measured using Cardiovascular Magnetic Resonance (CMR) imaging and a dual-bolus gadnolinium infusion protocol.~Myocardial perfusion index = the ratio between myocardial perfusion measurements following adenosine-induced stress and rest measurements." (NCT00239590)
Timeframe: Testosterone versus placebo (8 week treatment period)

Intervention	myocardial perfusion index (Mean)
Testosterone	1.83
Placebo	1.52

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Endothelial Function

The endothelium is a single layer of cells that line all blood vessels and regulates arterial function. Coronary artery disease causes dysfunction of the endothelium but some substances/drugs help to reverse this dysfunction. In this study, endothelial function was measured by radial applanation tonometry which measures the blood pressure waveform during each cardiac cycle (heart beat). Radial artery pulse recordings were acquired, with an averaged waveform generated from 20 sequential waveforms. Augmentation index (AIx) is derived from this averaged waveform, and is the ratio of the pulse pressure at the second systolic arterial pressure waveform peak to that of the first systolic peak. The change in AIx before and after salbutamol (400mcg) is a measure of endothelial function. (NCT00239590)
Timeframe: Testosterone versus placebo (8 week treatment period)

Intervention	Augmentation index (Mean)
Testosterone	76.5
Placebo	79.4

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Grip Strength

Change from baseline in grip strength in the dominant hand. (NCT00240981)
Timeframe: baseline and 6 months

Intervention	Kilograms (Mean)
Treatment	1.0
Placebo	0.7

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Late Life Functional Disability Index (LLFDI)

Percent change from baseline in the late life functional disability index at 6 months (NCT00240981)
Timeframe: baseline and 6 months

Intervention	units on a scale (Mean)
Treatment	61.2
Placebo	61.7

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Stair-climbing Test (Loaded)

Change from baseline in Stair-climbing Test (loaded) (NCT00240981)
Timeframe: baseline and 6 months

Intervention	Watts (Mean)
Treatment	39.2
Placebo	9.0

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50-Meter Walking Speed (With a Load)

Change from baseline 50-Meter Walking Speed (with a load) at 6 months (NCT00240981)
Timeframe: baseline and 6 months

Intervention	meters/second (Mean)
Testosterone	0.139
Placebo	0.065

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Total Fat Mass

(NCT00240981)
Timeframe: baseline, 3 months, and 6 months

Intervention	Kilograms (Mean)
	Baseline (N=82,81)	3 Months (N=73,75)	6 Months (N=77,80)
Placebo	28	28	27.5
Treatment	26.2	24.9	24.0

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Total Lean Mass

(NCT00240981)
Timeframe: baseline, 3 months, and 6 months

Intervention	Kilograms (Mean)
	Baseline	3 Months (N=73,75)	6 Months (N=77,80)
Placebo	56.5	56.7	56.2
Treatment	55.1	57.2	56.1

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Stair-climbing Test (Without a Load)

Change from baseline in the stair-climbing test (without a load) at 6 months. (NCT00240981)
Timeframe: baseline and 6 month

Intervention	Watts (Mean)
Treatment	19.5
Placebo	10.7

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50-Meter Walking Speed (Without a Load)

Change from baseline 50-Meter Walking Speed (without a load) at 6 months (NCT00240981)
Timeframe: baseline and 6 months

Intervention	meters/second (Mean)
Testosterone	0.074
Placebo	0.024

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Changes in Physical Performance Measured by an Exercise Testing Regimen

Primary outcome was a change from baseline in leg-press strength at 6 months. (NCT00240981)
Timeframe: baseline and 6 months

Intervention	Newtons (Mean)
Treatment	156.9
Placebo	27.1

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Chest-Press

Change from baseline in chest press strength at 6 months (NCT00240981)
Timeframe: baseline and 6 months

Intervention	Newtons (Mean)
Treatment	34.7
Placebo	0.28

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Resting Energy Expenditure

Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise. (NCT00266864)
Timeframe: 12 months

Intervention	kcal/day (Mean)
Testosterone Replacement Therapy	1440
No Intervention	1339

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Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)

"Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the on-and-off -the-table method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM." (NCT00266864)
Timeframe: 12 months

Intervention	kilograms (Mean)
Testosterone Replacement Therapy	53.1
No Intervention	50.5

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Change From Baseline in Chest Press Strength and Leg Press Strength

Maximal voluntary strength of the lower and upper extremities was assessed using the one repetition maximum (1-RM) method for the seated leg press and chest press exercises. Participants were positioned with standardized seat position and foot placement that allowed 90° of knee flexion for the leg press exercise. Seat height and handle position was standardized for the chest press. Participants were familiarized with the exercises, practiced the technique and completed a 5-minute warm-up. The 1-RM procedure consisted of a warm up set with 5 to 8 repetitions at a resistance set to about 50% of the participant's estimated 1-RM and progressed with increasing loads interspersed with standardized rest periods until the participant was able to perform only one full-range-of-motion repetition. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	newton (Mean)
	Chest Press Strength, Baseline	Chest Press Strength, Change at Month 36	Leg Press Strength, Baseline	Leg Press Strength, Change at Month 36
Placebo	513.83	-26.20	2233.74	-65.33
Testosterone	516.99	-12.73	2270.37	-37.26

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Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)

B-mode carotid artery images for IMT were acquired from the far wall of the distal centimeter of the right carotid artery with high-resolution ultrasound equipment. IMT is used as a predictor of the incidence of cardiovascular events. An increase in the IMT thickness is associated with a higher incidence of cardiovascular events. Less thickening is best. Change is expressed in millimeters (mm). (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	mm (Mean)
	Baseline	Change at Month 36
Placebo	0.879	0.033
Testosterone	0.877	0.036

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Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)

Cognitive Function was assessed by Complex Figure (Immediate) and (Delayed). The Complex Figure Test consists of three tasks: copy, immediate recall, and delayed recall. Participants were presented with a complex design and then asked to draw the same figure. Subsequently, they were instructed to draw what they remembered immediately, and after a 30 minute delay. Scoring was based on the number of correct items for a total possible score of 0 (worst) to 36 (Best). A positive change from Baseline indicates improvement. A negative change from Baseline indicates a worsening. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	correct items (Mean)
	Complex Figure:Immediate, Baseline	Complex Figure:Immediate, Change at Month 36	Complex Figure:Delayed, Baseline	Complex Figure:Delayed, Change at Month 36
Placebo	20.31	-0.24	19.75	-0.24
Testosterone	20.95	-1.25	20.28	-0.49

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Change From Baseline in Lipid Profiles

Laboratory tests included in the lipid profile were Total Cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides.Lower values for Total Cholesterol, LDL-C are better and a negative change from Baseline indicates improvement. Higher values for HDL-C are better and a positive change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	mg/dL (Mean)
	Total Cholesterol, Baseline	Total Cholesterol, Change at Month 36	HDL-C, Baseline	HDL-C, Change at Month 36	LDL-C, Baseline	LDL-C, Change at Month 36	Triglycerides, Baseline	Triglycerides, Change at Month 36
Placebo	183.44	-12.56	48.71	2.00	109.66	-13.92	138.95	-12.62
Testosterone	187.15	-14.88	47.11	0.18	115.64	-11.24	142.695	-19.41

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Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)

IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (6 questions), orgasmic function (2 questions), sexual desire (2 questions), intercourse satisfaction (3 questions), and overall sexual satisfaction (2 questions). Each question was answered on a 5-point scale from 1 to 5 (best) with a total possible score range of 0 to 75 with higher scores representing better function. A positive change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	score on a scale (Mean)
	Erectile Function, Baseline	Erectile Function, Change at Month 36	Orgasmic Function, Baseline	Orgasmic Function, Change at Month 36	Sexual Desire, Baseline	Sexual Desire, Change at Month 36	Intercourse Satisfaction, Baseline	Intercourse Satisfaction, Change at Month 36	Overall Satisfaction, Baseline	Overall Satisfaction, Change at Month 36	Total Score, Baseline	Total Score, Change at Month 36
Placebo	18.67	-0.80	6.38	0.24	6.58	0.07	8.14	-0.71	6.12	0.81	49.67	-0.39
Testosterone	18.33	-0.15	7.37	-0.65	6.89	0.18	8.32	0.05	6.24	0.40	48.48	0.22

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Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)

The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. The Overall Score is the average of the individual domain scores. A negative change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	score on a scale (Mean)
	Energy/Fatigue, Baseline	Energy/Fatigue, Change at Month 36	Emotional Well-Being, Baseline	Emotional Well-Being, Change at Month 36	Role Limitations/Emotional Problems, Baseline	Role Limitations/Emotional Problems,Change	Social Functioning, Baseline	Social Functioning, Change at Month 36	Physical Functioning, Baseline	Physical Functioning, Change at Month 36	Role Limitations/Physical Health, Baseline	Role Limitations,/Physical Health, Change	Pain, Baseline	Pain, Change at Month 36	General Health, Baseline	General Health, Change at Month 36	Overall Score, Baseline	Overall Score, Change at Month 36
Placebo	71.21	-0.46	83.17	0.91	89.08	-9.09	92.89	-4.83	83.28	-2.39	88.79	-9.66	82.24	-5.97	76.72	-3.75	83.42	-4.40
Testosterone	69.92	-1.45	82.67	-1.16	90.00	3.51	90.42	-3.29	82.00	-3.82	80.00	-1.97	82.83	-7.96	74.17	-0.53	81.50	-2.08

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Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power

Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. A negative change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	watts (Mean)
	Unloaded Stair Climb Power, Baseline	Unloaded Stair Climb Power, Change at Month 36	Loaded Stair Climb Power, Baseline	Loaded Stair Climb Power, Change at Month 36
Placebo	535.78	-12.89	594.84	-12.76
Testosterone	536.33	-8.17	581.24	-8.44

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Change From Baseline in the Verbal Fluency Test

Cognitive function was assessed by the Verbal Fluency Test. Participants were asked to name as many letters from a given category as possible in 1 minute. Higher number of letters is best and a positive change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	letters (Mean)
	Baseline	Change at Month 36
Placebo	27.02	1.77
Testosterone	26.96	2.86

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Change From Baseline in Coronary Artery Calcium Score

"A multiple detector computed tomography (MDCT) scan was performed. Proximal coronary arteries were visualized, and at least 30 consecutive images were obtained at 3-mm intervals. Coronary calcium was defined as a plaque of at least 3 contiguous pixels (area, 1.02 mm^2) with a density of more than 130 Hounsfield units.The lesion score was calculated by multiplying lesion area by a density factor derived from Hounsfield units. The Agatston method was used to determine the total calcium score by summing the lesion scores from the left main, left anterior descending, circumflex, and right coronary arteries. The Agatston score is the measure of calcification in arteries expressed on continuous scale with 0 value (better) indicating no calcification and score above 400 (worse) indicating high calcification. There is no upper limit for this measure. A positive change from baseline indicates a worsening." (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	score on a scale (Mean)
	Baseline	Change at Month 36
Placebo	508.31	124.54
Testosterone	451.78	103.61

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Change From Baseline in Paragraph Recall Test (Delayed)

Cognitive Function was assessed by the Paragraph Recall Test (Delayed). In the Paragraph Recall Test, participants were read two short paragraphs and asked to recall them immediately and after a 30 minute delay, using the exact words that were read aloud. Scoring was based on the number of items correctly recalled. More items correctly recalled is best and a positive change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	correct items (Mean)
	Paragraph: Delayed, Baseline	Paragraph:Delayed, Change at Month 36
Placebo	13.57	1.72
Testosterone	13.69	2.15

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Change From Baseline in the Trail Making Test B

Cognitive function was assessed by the Trail Making Test B. Trail Making Test B involved participants connecting numbers (1-13) and letters (A-L) alternately (1-A, 2-B, etc) on a piece of paper as quickly as possible. Scores represent the time it takes the participant to complete the test. Less time is best and a negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	seconds (Mean)
	Trails B, Baseline	Trails B, Change at Month 36
Placebo	97.57	11.26
Testosterone	98.52	3.88

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Change From Baseline in the Stroop Interference Test

Cognitive function was assessed by the Stroop Interference Test. In the Stroop Interference Test, participants were presented with a word list of colors printed in ink of a color different from how the printed word read. Participants were instructed to read aloud the color of the ink in which a word was printed, while not verbalizing the word itself. The time in seconds that the items were correctly identified was recorded. Less time is better and a negative change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	seconds (Mean)
	Stroop Interference, Baseline	Stroop Interference, Change at Month 36
Placebo	56.84	0.99
Testosterone	55.64	-1.07

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Change From Baseline in the Category Fluency Test

Cognitive function was assessed by the Category Fluency Test. Participants were asked to name as many items from a given category as possible. Higher number of items named is best and a positive change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	items (Mean)
	Category Fluency, Baseline	Category Fluency, Change at Month 36
Placebo	18.01	0.37
Testosterone	18.07	2.25

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Change From Baseline in the Buschke Selective Reminding Test (Delayed)

Cognitive function was assessed by the Buschke Selective Reminding Test. In the Buschke Selective Reminding Test, participants were read 12 words and asked to recall as many words as possible. Subsequent trials included only those words that were not recalled in the preceding trial. Individuals were also asked to recall the list 30 minutes later. To assess phonemic and category fluency, participants were asked to name as many items from a given category as possible in 1 minute. Higher number of correct items is best and a positive change from Baseline indicates improvement. (NCT00287586)
Timeframe: Baseline and Month 36

Intervention	correct items (Mean)
	Buschke Total Correct Delayed, Baseline	Buschke Total Correct Delayed, Change at Month 36
Placebo	7.76	0.85
Testosterone	8.00	0.47

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Montgomery Asberg Depression Rating Scale (MADRS)

The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms). (NCT00304746)
Timeframe: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)

Intervention	units on a scale (Mean)
Testosterone Gel	17.9
Placebo Gel	19.9

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21-item Hamilton Depression Rating Scale Score (HAM-D)

The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression). (NCT00304746)
Timeframe: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)

Intervention	units on a scale (Mean)
Testosterone Gel	13.5
Placebo Gel	15.6

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Change in Serum Testosterone Level

Total Serum Testosterone Level (ng/mL) (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	ng/mL (Mean)
Exercise + Placebo	-15.3
Exercise + Testosterone	121.2

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Change in Skeletal Muscle Strength by 1-RM

One-repetition maximum strength for leg extension (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	lbs. (Mean)
Exercise + Placebo	59.2
Exercise + Testosterone	70.3

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Change in Serum Total Cholesterol Level

(NCT00345969)
Timeframe: Baseline and Six Months

Intervention	mg/dL (Mean)
Exercise + Placebo	-3.2
Exercise + Testosterone	-9.0

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Mean Change in Total Lean Body Mass

Total Lean Mass measured by Dual X-ray Absorptiometry (DXA) (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	kg (Mean)
Exercise + Placebo	0.5
Exercise + Testosterone	2.3

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Change in Total Body Fat Mass

Total Body Fat Mass as measured by DXA (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	kg (Mean)
Exercise + Placebo	-0.51
Exercise + Testosterone	-1.1

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Change in Femoral Bone Mineral Density (BMD)

Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA) (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	g/cm2 (Mean)
Exercise + Placebo	-0.008
Exercise + Testosterone	0.084

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Change in Hematocrit

Percentage of the volume of whole blood composed of Red Blood Cells (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	percent (Mean)
Exercise + Placebo	0.14
Exercise + Testosterone	2.5

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Change in Isokinetic Leg Extension Torque at 0 Deg/Sec

Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	ft/lb (Mean)
Exercise + Placebo	10.4
Exercise + Testosterone	19.8

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Change in Serum Prostate Specific Antigen (PSA) Level

(NCT00345969)
Timeframe: Baseline and Six Months

Intervention	ng/mL (Mean)
Exercise + Placebo	0.05
Exercise + Testosterone	0.21

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Change in Leg Extension Torque at 60 Deg/Sec

Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	ft/lb (Mean)
Exercise + Placebo	12.7
Exercise + Testosterone	19.4

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Change in Serum HDL Cholesterol Level

(NCT00345969)
Timeframe: Baseline and Six Months

Intervention	mg/dL (Mean)
Exercise + Placebo	-1.4
Exercise + Testosterone	1.7

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Change in Serum LDL Cholesterol Level

(NCT00345969)
Timeframe: Baseline and Six Months

Intervention	mg/dL (Mean)
Exercise + Placebo	-3.6
Exercise + Testosterone	-1.6

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Change in Total Modified Physical Performance (mPPT) Score

The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living [ADL]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score. (NCT00345969)
Timeframe: Baseline and Six Months

Intervention	units on a scale (Mean)
Exercise + Placebo	5.0
Exercise + Testosterone	2.8

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Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone

To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks. (NCT00350701)
Timeframe: 8 week

Intervention	percentage of baseline value (Mean)
	baseline	8 week
Androgel 10g	100	130
Androgel 5g	100	68
Placebo	100	95

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Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo

Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups (NCT00350701)
Timeframe: 8 weeks

Intervention	percentage of baseline value (Mean)
	baseline	8 week
Androgel 10g	100	125
Androgel 5g	100	91
Placebo	100	110

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Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo

To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups (NCT00350701)
Timeframe: 8 weeks

Intervention	Percent change from baseline (Mean)
	baseline	8 week
Androgel 10g	100	82
Androgel 5g	100	236
Placebo	100	100

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Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14

All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The plasma glucose level were analyzed at baseline and at 60 and 120 min after glucose loading. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	mmol/L (Mean)
	Fasting glucose	OGTT 1-h glucose	OGTT 2-h glucose
Androgel (Testosterone Gel)	5.2	8.0	6.7
Placebo	5.6	8.3	6.1

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Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14

The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	units on a scale (Mean)
	Physical functioning	Bodily pain	Role limitations due to physical health problems	Role limitations due to emotional problems	Emotional well-being	Social functioning	Energy-fatigue	General health perceptions
Androgel (Testosterone Gel)	42	62	23	56	64	57	44	55
Placebo	42	61	22	37	63	54	40	52

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Ice Water-induced Cold Pain and Its After-sensation at Week 14

Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	seconds (Mean)
	Cold pain tolenrance	Cold pain after sensation: 30s
Androgel (Testosterone Gel)	54.2	13.1
Placebo	54.1	13.9

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Inflammatory Cytokines at Week 14

The pathophysiology of pain is measured by the proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-Alpha). (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	pg/mL (Mean)
	IL-6	TNF-Alpha
Androgel (Testosterone Gel)	2.4	1.9
Placebo	2.6	2.1

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Lipid Profile at Week 14

Serum total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol levels were measured by enzymatic assays and standardized to the CDC using the Lipid Research Clinic protocol. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	mmol/L (Mean)
	Total cholesterol	LDL	HDL	Triglycerides
Androgel (Testosterone Gel)	4.8	2.9	1.0	1.8
Placebo	5.1	3.1	1.1	1.9

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Pain Catastrophizing Scale (PCS) at Week 14

PCS questionnaire measures self-assessment of pain catastrophizing. This questionnaire consists of 13 items on past painful experiences and rate on 5-point scales ranging from 0 (not at all) to 4 (all the time). The PCS yields three subscale scores assessing rumination (range 0-16), magnification (range 0-12), helplessness (range 0-24), and a composite score (sum of three domains, ranging 0-52). Higher score represents worse painful experiences. (NCT00351819)
Timeframe: Values at week 14 after intervention

Intervention	units on a scale (Mean)
	Composite score	Rumination score	Magnification score	Helplessness score
Androgel (Testosterone Gel)	20	7.1	3.7	9.2
Placebo	21	7.6	4.1	8.4

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Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14

IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function. (NCT00351819)
Timeframe: Week14 after intervention

Intervention	units on a scale (Mean)
	Total score	Erectile function	Orgasmic funcion	Sexual desire	Intercourse satisfaction	Overall satisfaction
Androgel (Testosterone Gel)	51.3	21.7	7.7	6.8	9.1	6.1
Placebo	47.1	19.2	6.4	6.3	9.0	6.1

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Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14

Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	watts (Mean)
	First Stimulus	10th Stimulus
Androgel (Testosterone Gel)	10.9	21.9
Placebo	11.7	22.2

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Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14

All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The insulin level were analyzed at baseline and at 60 and 120 min after glucose loading. (NCT00351819)
Timeframe: Values at week 14 after intervention

Intervention	pmol/L (Mean)
	Fasting insulin	OGTT 1-h insulin	OGTT 2-h insulin
Androgel (Testosterone Gel)	70	279	231
Placebo	110	407	325

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Adiponectin at Week 14

Total adiponectin was measured using an RIA kit with an interassay CV of 6.9-9.3% and an intra-assay CV of 1.8-6.2% (Millipore). (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	ug/mL (Mean)
Androgel (Testosterone Gel)	4.8
Placebo	4.7

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C-reactive Protein (CRP) at Week 14

High-sensitivity C-reactive protein (Alpco Diagnostics) was measured using a high-sensitivity sandwich ELISA with an intra-assay CV of 5.6% (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	mg/L (Mean)
Androgel (Testosterone Gel)	4.2
Placebo	3.4

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Free Testosterone Values at Week 14

Free testosterone was calculated using a law of mass action equation. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	pg/mL (Mean)
Androgel (Testosterone Gel)	189
Placebo	65

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HbA1c at Week 14

(NCT00351819)
Timeframe: Week 14 after intervention

Intervention	percentage of glycosylated hemogobin (Mean)
Androgel (Testosterone Gel)	5.7
Placebo	6.1

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HOMA IR Score at Week 14

Insulin resistance was calculated using the homeostatic model assessment (HOMA) index: glucose * insulin / 22.5. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	HOMA IR score (Mean)
Androgel (Testosterone Gel)	2.5
Placebo	4.2

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Insomnia Severity Index (ISI) at Week 14

ISI is comprised of 7 items assesses a participant's perception of insomnia. Each item is rated on a 5-point scale from 0 (none) to 4 (very severe). Scores from the questions are summed to assign a total score ranging from 0 to 28, where higher score represents worse insomnia problem. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	units on a scale (Mean)
Androgel (Testosterone Gel)	10.8
Placebo	11.1

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Leptin at Week 14

Leptin levels were measured using ELISA with an interassay CV of 2.6% to 6.2% and in intra-assay CV of 2.6% to 4.6% (Millipore, Billerica, MA, USA). (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	ug/L (Mean)
Androgel (Testosterone Gel)	16
Placebo	21

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Luteinizing Hormone Values at Week 14

Luteinizing hormone was measured using immunofluorometric assays, with limits of quantification of 0.05 U/L. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	U/L (Mean)
Androgel (Testosterone Gel)	1.6
Placebo	3.5

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Sex Hormone Binding Globulin (SHBG) at Week 14

Sex hormone binding globulin was measured using immunofluorometric assays, with limits of quantification of 2.5 nmol/L. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	nmol/L (Mean)
Androgel (Testosterone Gel)	34.6
Placebo	35.0

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Total Testosterone Values at Week 14

Total testosterone was measured in a CDC-certified laboratory using an LC-MS/MS method with a sensitivity of 2 ng/dL. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	ng/dL (Mean)
Androgel (Testosterone Gel)	790
Placebo	328

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Algometer-induced Pressure Pain at Week 14

A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	kPa/cm2 (Mean)
	Trapezius	Thumb
Androgel (Testosterone Gel)	379.4	409.7
Placebo	315.9	326.4

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Body Composition at Week 14

Body composition was measured using dual-energy X-ray absorptiometry scan. (NCT00351819)
Timeframe: Week 14 after intervention

Intervention	kg (Mean)
	Lean mass	Fat mass	Total mass	Appendicular lean mass	Appendicular fat mass	Appendicular total mass
Androgel (Testosterone Gel)	57.8	25.7	83.5	27.9	11.4	38.6
Placebo	60.9	27.9	88.7	29.4	12.1	40.8

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Brief Pain Inventory (BPI) at Week 14

BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain). (NCT00351819)
Timeframe: Week14 after intervention

Intervention	units on a scale (Mean)
	Total score	Severity	Interference
Androgel (Testosterone Gel)	10.2	5.3	5.0
Placebo	9.7	5.1	4.7

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Change in Basal FFAs in Plasma

FFA (plasma free fatty acids) are measure of lipid metabolism (NCT00365794)
Timeframe: Baseline to week 20

Intervention	mEq/L (Median)
Single Arm	-0.1

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Change in Hepatic Lipid

Amount of liver fat is highly predictive of insulin resistance. Hepatic fat is measured by MR spectroscopy and adjusted for H2O and results are reported as ratio of these two. (NCT00365794)
Timeframe: Baseline to week 20

Intervention	ratio (Median)
Single Arm	-36

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Change in HOMA-IR

HOMA-IR is a measure of insulin resistance (NCT00365794)
Timeframe: Baseline to week 20

Intervention	microU/L) x fasting glucose (nmol/L)/22 (Median)
Single Arm	-0.75

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Change in Percentage of Total Body Fat

Percentage of total body fat is quantified by DEXA scanning (NCT00365794)
Timeframe: Baseline and 20 weeks

Intervention	percentage of total body fat (Median)
Single Arm	-1.6

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Change in Plasma Free Fatty Acids During Glucose Clamp

(NCT00365794)
Timeframe: Baseline to 20 weeks

Intervention	grams (Median)
Single Arm	-0.1

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Change in Skeletal Muscle Mass by DEXA

Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle. (NCT00365794)
Timeframe: Baselne to 20 weeks

Intervention	kilograms (Median)
Single Arm	1.2

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Intramyocellular Lipid (IMCL)

IMCL is quantified by MR spectroscopy of the anterior tibialis muscle of the leg. The value is adjusted for creatine and reported as a ratio (NCT00365794)
Timeframe: Baseline to week 20

Intervention	ratio (Median)
Single Arm	-30

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Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO])

In the final analysis, total and regional carbohydrate metabolism during a 2-hr hyperinsulinemic euglycemic clamp (peripheral glucose disposal [Rd],hepatic glucose output [HGO]) were analyzed by mass transfer of glucose during both stages of the clamp relative to insulin levels. (NCT00365794)
Timeframe: Baseline and 20 weeks

Intervention	dL/min per μU/mL (Median)
	Whole body insulin sensitiity	hepaic glucose output (HGO)	peripheral glucose disposal (Rd)
Single Arm	1.05	-0.16	1.16

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Change in Total Mass and Regional Adipose Adiposiy

Change in total body mass, total fat mass, trunk fat, and extremity fat (NCT00365794)
Timeframe: Baseline to 20 weeks

Intervention	kilograms (Median)
	Total body mass	Total fat mass	Trunk fat mass	Extremity fat mass
Single Arm	0.3	-1.4	-0.9	-0.7

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Plasma Lipids

(NCT00365794)
Timeframe: Baseline to week 20

Intervention	mg/dL (Median)
	Fasting triglycerides	Total cholesterol	LDL cholesterol	HDL cholesterol
Single Arm	-0.33	-0.52	-0.23	-0.10

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Whole Brain Atrophy Rate

as assessed by Voxel-Based Morphometry (NCT00405353)
Timeframe: Baseline and 12 months

Intervention	percent change in brain volume (Mean)
Testosterone Arm/ Group	.82

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IIEF-IV: Intercourse Satisfaction

Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied) (NCT00413244)
Timeframe: At baseline, 1 month, 3 months, and 6 months

Intervention	units on a scale (Mean)
	at baseline	at 1 month	at 3 months	at 6 months
Androgel	5.5	6.2	6.8	6.9
Placebo	5.0	3.6	6.0	5.2

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IIEF-II Orgasmic Function

Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment) (NCT00413244)
Timeframe: At baseline, 1 month, 3 months, and 6 months

Intervention	units on a scale (Mean)
	at baseline	at 1 month	at 3 months	at 6 months
Androgel	4.8	5.9	5.7	6.1
Placebo	4.4	4.2	5.8	5.5

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IIEF -III: Sexual Desire

Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high) (NCT00413244)
Timeframe: At baseline, 1 month, 3 months, and 6 months

Intervention	units on a scale (Mean)
	at baseline	at 1 month	at 3 months	at 6 months
Androgel	5.0	5.6	6.3	6.6
Placebo	5.4	4.8	5.6	5.5

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Cardiac Stress Testing: Exercise Capacity

Exercise capacity was measured using exercise time. (NCT00413244)
Timeframe: At 1 month, 3 months, and 6 months

Intervention	seconds (Mean)
	at 1 month	at 3 months	at 6 months
Androgel	589.7	607.6	614.0
Placebo	452.4	472.1	470.0

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Cardiac Stress Test: Time to ST Depression

Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias. (NCT00413244)
Timeframe: at 6 months

Intervention	seconds (Mean)
	at 1 month	at 3 months	at 6 months
Androgel	439.1	364.0	433.0
Placebo	279.5	292.6	342.2

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Aging Male Symptoms (AMS)

The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.) (NCT00413244)
Timeframe: At baseline, 1 month, 3 months, and 6 months

Intervention	units on a scale (Mean)
	Baseline	At 1 month	At 3 months	At 6 months
Androgel	36.5	32.9	36.5	31.2
Placebo	35.8	29.8	35.9	31.4

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Metabolic Equivalents of Task (METS)

The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg-1·min-1 or equivalently (NCT00413244)
Timeframe: 6 months

Intervention	METS units (Mean)
	at baseline	at 1 month	at 3 months	at 6 months
Androgel	11.0	11.4	11.9	12.2
Placebo	9.0	9.0	9.2	9.4

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Reactive Hyperemia Index

The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes. (NCT00413244)
Timeframe: 6 months

Intervention	mls (Mean)
	At baseline	at 1 month	at 3 months	at 6 moths
Androgel	1.96	1.85	1.70	1.83
Placebo	1.85	1.81	1.77	1.74

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International Index of Erectile Function (IIEF)

Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction). (NCT00413244)
Timeframe: At baseline, 1 month, 3 months, and 6 months

Intervention	units on a scale (Mean)
	at baseline	at 1 month	at 3 months	at 6 months
Androgel	12.4	14.1	15.7	15.0
Placebo	12.2	10.1	14.2	12.5

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IIEF-V: Over-all Satisfaction

Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied) (NCT00413244)
Timeframe: At baseline, 1 month, 3 months, and 6 months

Intervention	units on a scale (Mean)
	at baseline	at 1 month	at 3 months	at 6 months
Androgel	4.8	4.9	5.2	6.0
Placebo	4.3	3.8	5.2	4.9

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Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.

The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%. (NCT00433199)
Timeframe: Day 266

Intervention	Percentage of subjects (Number)
Continuing Active T-Gel 1.62% (CA)	78.4
Formerly Placebo (FP)	69.2
Combined (CA and FP)	77.0

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Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.

The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%. (NCT00433199)
Timeframe: Day 364

Intervention	Percentage of subjects (Number)
Continuing Active T-Gel 1.62% (CA)	77.9
Formerly Placebo (FP)	87.0
Combined (CA and FP)	79.2

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Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112

Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results (NCT00433199)
Timeframe: Day 112

Intervention	Percentage of subjects (Number)
T-Gel 1.62%	81.6
Placebo	37.0

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Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14

Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results (NCT00433199)
Timeframe: Day 14

Intervention	Percentage of subjects (Number)
T-Gel 1.62%	65.7
Placebo	29.7

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Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182

Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results. (NCT00433199)
Timeframe: Day 182

Intervention	Percentage of subjects (Number)
T-Gel 1.62%	82.2
Placebo	28.6

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Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56

Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results (NCT00433199)
Timeframe: Day 56

Intervention	Percentage of subjects (Number)
T-Gel 1.62%	82.5
Placebo	34.4

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Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1

Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies (NCT00467259)
Timeframe: 52 weeks

Intervention	# Endometrial Hyperplasia/Evaluable Biop (Number)
Placebo	0
Testosterone	0

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Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1

Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies (NCT00467259)
Timeframe: 52 weeks

Intervention	# Endometrial Hyperplasia/Evaluable Biop (Number)
Placebo	0
Testosterone	0

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Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1

Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies (NCT00467259)
Timeframe: 52 weeks

Intervention	# Endometrial Hyperplasia/Evaluable Biop (Number)
Placebo	0
Testosterone	0

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Serum Total Testosterone Maximum Concentration in Part B

(NCT00467870)
Timeframe: Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80

Intervention	ng/dL (Mean)
B-TU 750 mg	986.364
B-TU 1000 mg	1047.739

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Serum Total Testosterone Maximum Concentration in Part C2

(NCT00467870)
Timeframe: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44

Intervention	ng/dL (Mean)
C2-TU 750 mg	711.343

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Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	days (Mean)
C-TU 750 mg	60.6

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Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C

M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied). (NCT00467870)
Timeframe: Day 21 post injection at week 14

Intervention	percentage of participants (Number)
	Confidence or Self-Esteem Improved	Confidence or Self-Esteem No Change	Confidence or Self-Esteem Worsened	Satisfaction with Sexual Performance Improved	Satisfaction with Sexual Performance No Change	Satisfaction with Sexual Performance Worsened	General Moods and Behavoir Improved	General Moods and Behavoir No Change	General Moods and Behavoir Worsened	Overal Feeling of Well-Being Improved	Overal Feeling of Well-Being No Change	Overal Feeling of Well-Being Worsened	Satisfaction with Study Treatment Satisfied	Satisfaction with Study Treatment No Opinion	Satisfaction with Study Treatment Not Satisfied
C-TU 750 mg	82.6	17.4	0	80.0	17.4	2.6	80.9	19.1	0	81.7	18.3	0	92.2	7.8	0

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Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2

Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL. (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

Intervention	percentage of participants (Number)
	Cmax ≤1500 ng/dL	Cmax 1800-2500 ng/dL	Cmax >2500 ng/dL
C2-TU 750 mg	95.7	0	0

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Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

Intervention	percentage of participants (Number)
	Cmax >1000 ng/dL	Cmax >1100 ng/dL	Cmax >1250 ng/dL	Cmax <300 or >1000 ng/dL
C2-TU 750 mg	8.7	4.3	4.3	60.9

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Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2

Serum total testosterone concentrations outside the normal range are categorized as <300 ng/dL (below lower limit of normal range) and >1000 ng/dL (above upper limit of normal range) (NCT00467870)
Timeframe: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44

Intervention	percentage of participants (Number)
	Screening, <300 ng/dL	Screening, >1000 ng/dL	Day 0, <300 ng/dL	Day 0, >1000 ng/dL	Day 0 at Week 4, <300 ng/dL	Day 0 at Week 4, >1000 ng/dL	Day 4 post injection at Week 4, <300 ng/dL	Day 4 post injection at Week 4, >1000 ng/dL	Day 7 post injection at Week 4, <300 ng/dL	Day 7 post injection at Week 4, >1000 ng/dL	Day 11 post injection at Week 4, <300 ng/dL	Day 11 post injection at Week 4, >1000 ng/dL	Day 14 post injection at Week 4, <300 ng/dL	Day 14 post injection at Week 4, >1000 ng/dL	Week 14, <300 ng/dL	Week 14, >1000 ng/dL	Week 24, <300 ng/dL	Week 24, >1000 ng/dL	Week 34, <300 ng/dL	Week 34, >1000 ng/dL	Week 44, <300 ng/dL	Week 44, >1000 ng/dL
C2-TU 750 mg	100.0	0	91.3	0	78.3	0	15.0	5.0	0	9.1	0	4.5	0	4.8	52.2	0	47.8	0	36.4	0	35.0	0

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Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	percentage of participants (Number)
	Cmax ≤1500 ng/dL	Cmax >1500-<1800 ng/dL	Cmax 1800-2500 ng/dL	Cmax >2500 ng/dL
C-TU 750 mg	92.3	7.7	0	0

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Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	percentage of participants (Number)
	Cmax ≤1500 ng/dL	Cmax >1500 to <1800 ng/dL	Cmax 1800 to 2500 ng/dL	Cmax >2500 ng/dL
C-TU 750 mg	92.3	3.8	3.8	0

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Change in Body Mass Index From Baseline to Week 24 in Part C

Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2) (NCT00467870)
Timeframe: Baseline, Week 24

Intervention	kg/m2 (Mean)
C-TU 750 mg	0.023

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Change in Weight From Baseline to Week 24 in Part C

(NCT00467870)
Timeframe: Baseline, Week 24

Intervention	kg (Mean)
C-TU 750 mg	0.06

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Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C

Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval. (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	percentage of participants (Number)
C-TU 750 mg	94.0

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Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C

Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval. (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	percentage of participants (Number)
C-TU 750 mg	96.2

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Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	percentage of participants (Number)
C-TU 750 mg	37.5

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Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	percentage of participants (Number)
C-TU 750 mg	96.2

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Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

Intervention	pg/mL (Mean)
	Day 0 (n=23)	Day 4 (n=20)	Day 7 (n=22)	Day 11 (n=22)	Day 14 (n=21)	Day 70 (n=23)
C2-TU 750 mg	180.33	301.85	322.74	332.92	324.74	230.71

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Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C

Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	percentage of participants (Number)
C-TU 750 mg	53.8

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Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C

Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	percentage of participants (Number)
C-TU 750 mg	62.5

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Serum Total Testosterone Concentrations in Part C2

(NCT00467870)
Timeframe: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44

Intervention	ng/dL (Mean)
	Screening (n=22)	Day 0 (n=23)	Day 0 at Week 4 (n=23)	Day 4 post injection at Week 4 (n=20)	Day 7 post injection at Week 4 (n=22)	Day 11 post injection at Week 4 (n=22)	Day 14 post injection at week 4 (n=21)	Week 14 (n=23)	Week 24 (n=23)	Week 34 (n=22)	Week 44 (n=20)
C2-TU 750 mg	197.629	210.363	254.669	578.419	606.484	580.614	545.236	317.419	316.215	374.698	375.797

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Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	percentage of participants (Number)
C-TU 750 mg	94.9

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Trough Assessments of Serum Total Testosterone Concentrations in Part C2

(NCT00467870)
Timeframe: Screening; day 0; and weeks 4, 14, 24, 34, and 44

Intervention	ng/dL (Mean)
	Screening (n=22)	Day 0 (n=23)	Week 4 (n=23)	Week 14 (n=23)	Week 24 (n=23)	Week 34 (n=22)	Week 44 (n=20)
C2-TU 750 mg	197.629	210.363	254.669	317.419	316.215	374.698	375.797

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Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C

Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL. (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	percentage of participants (Number)
	Cmax ≤1500 ng/dL	Cmax 1800-2500 ng/dL	Cmax >2500 ng/dL
C-TU 750 mg	92.3	0	0

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Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	days (Mean)
C-TU 750 mg	50.2

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Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2

Serum total testosterone Ctrough derived from the 2nd injection IPK interval (NCT00467870)
Timeframe: Day 70 post injection at week 4

Intervention	ng/dL (Mean)
C2-TU 750 mg	317.419

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Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2

Serum total testosterone Cavg derived from the 2nd injection IPK interval (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

Intervention	ng/dL (Mean)
C2-TU 750 mg	449.6455

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Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C

Serum total testosterone Cavg derived from the 3rd injection IPK interval (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	ng/dL (Mean)
C-TU 750 mg	494.9373

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Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C

Serum total testosterone Cavg derived from the 4th injection IPK interval (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	ng/dL (Mean)
C-TU 750 mg	514.2792

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Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C

Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval (NCT00467870)
Timeframe: Day 70 post injection at week 14

Intervention	ng/dL (Mean)
C-TU 750 mg	323.522

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Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C

Serum total testosterone Ctrough derived from the 4th injection IPK interval (NCT00467870)
Timeframe: Day 70 post injection at week 24

Intervention	ng/dL (Mean)
C-TU 750 mg	342.800

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Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C

Intervention	percentage of participants (Number)
	Cmax ≤1500 ng/dL	Cmax 1800-2500 ng/dL	Cmax >2500 ng/dL
C-TU 750 mg	92.3	3.8	0

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Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	percentage of participants (Number)
C-TU 750 mg	51.3

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Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2

Serum total testosterone Cmax derived from the 2nd injection IPK interval (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, and 70 post injection at week 4

Intervention	ng/dL (Mean)
C2-TU 750 mg	689.002

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Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C

Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Intervention	ng/dL (Mean)
C-TU 750 mg	890.583

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Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C

Serum total testosterone Cmax derived from the 4th injection IPK interval (NCT00467870)
Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Intervention	ng/dL (Mean)
C-TU 750 mg	837.648

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Serum Total Testosterone Maximum Concentration in Part A

(NCT00467870)
Timeframe: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120

Intervention	ng/dL (Mean)
A-TU 750 mg	805.867
A-TU 1000 mg	1023.591

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Dietary Protein Intake

"Dietary protein intake will be assessed using a 3-day food log and subjects will be counseled to increase protein intake if needed using the guide Healthy Ways to Eat More Protein." (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	gm/body weight (kg) (Mean)
	protein intake baseline	protein intake 3 months	protein intake 6 months	protein intake 9 months	protein intake 12 months n = 1,1,2,5
Arm 1	0.97	0.87	0.74	1.15	1.18
Arm 2	1.06	0.94	1.27	1.20	0.74
Arm 3	0.99	1.49	1.05	1.26	1.39
Arm 4	1.00	1.12	0.93	0.82	1.05

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Transrectal Ultrasound Sizing of Prostate

Transrectal ultrasound sizing of prostate will be performed using the B&K Diagnostic System 3535, with 7 mega hertz transrectal probe at baseline and after 6 and 12 months of treatment. (NCT00475501)
Timeframe: baseline, 6 month, 12 months

,,,

Intervention	cc (Mean)
	postate volume baseline cc	change prostate volume 6 months cc	change prostate volume 12 months cc
Arm 1	26.4	7.626	11.42
Arm 2	29.7	-1.984	-4.93
Arm 3	37.1	-3.927	-1.72
Arm 4	36.9	-1.474	-2.891

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Trail-Making Test, Part A

Trail-Making Test, Part A: is a standardized test of cognitive function which specifically assesses working memory, visual processing, visual spatial skills, selective and divided attention, and psychomotor coordination. the test is scored as seconds required to successful completion of the task with a lower score representing better performance. The mean score on test is 30.75 second with a standard deviation of 16.27. (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	sec (Mean)
	Trails A baseline	Trails A 3 months	Trails A 6 months	Trails A 9 months	Trails A 12 months
Arm 1	37.59	38.5	32.9	31.0	29.17
Arm 2	46.42	42.1	39.0	38.56	40.0
Arm 3	36.65	33.53	31.2	29.07	32.5
Arm 4	44.0	44.33	36.92	43.17	43.75

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1 Repetition Maximum (1-RM) Strength Testing

1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment. (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	kg (Mean)
	leg press baseline Kg	leg press 3-months change kg	leg press 6-months change kg	leg press 9-months change kg	leg press 12-months change kg
Arm 1	129.1	9.192	10.227	14.416	14.773
Arm 2	109.4	-1.34	-1.136	-5.55	0
Arm 3	137.2	9.679	13.778	10.49	12.5
Arm 4	118.8	-2.44	2.727	2.02	1.515

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Lumbar Spine L2-L4 Bone Mineral Density

Dual x-ray absorptiometry (DXA): We will assess bone mineral density (BMD) and body composition using a fan-bean densitometer (Lunar Prodigy, General Electric Medical Systems). (NCT00475501)
Timeframe: baseline, 12 months

,,,

Intervention	gm/cc (Mean)
	L2-L4 spine BMD baseline gm/cc	change L2-L4 spine BMD 12 month gm/cc
Arm 1	1.03	0.049
Arm 2	1.02	0.002
Arm 3	0.99	0.053
Arm 4	1.07	-0.020

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30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test

"Rey Osterrieth Complex Figure (ROCF) test is a widely used standardized neuropsychological test for assessing visuospatial constructional functions, visuographic memory, and some aspects of planning.~The drawing is scored by a blinded neuropsychologist on a scale of 0 to 30 with 30 representing a perfect drawing." (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	units on a scale (Mean)
	Rey baseline	Rey 3 month	Rey 6 month	Rey 9 month	Rey 12 month
Arm 1	12.42	16.68	15.76	15.25	16.86
Arm 2	13.54	12.85	16.17	15.17	15
Arm 3	12.82	16.27	17.38	18.08	19.27
Arm 4	12.8	12.5	14	15.55	16.45

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Benton Judgment of Line Orientation Test

"Benton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition" (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	units on a scale (Mean)
	Benton baseline	Benton 3 months	Benton 6 months	Benton 9 months	Benton 12 months
Arm 1	24.54	25.00	25.90	25.38	25.67
Arm 2	24.39	25.40	25.11	23.89	25.5
Arm 3	25.88	25.07	26.0	25.79	26.17
Arm 4	24.69	25.67	25.08	24.92	24.08

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Life Satisfaction

Life Satisfaction: is a written test of psychological well-being that will be performed at baseline, after 3, 6, 9 and 12 months of treatment. This is a 20-point scale, with a possible range of scores from 0 to 20. A higher score represents greater life satisfaction. (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	points (Mean)
	Life Satisfaction A baseline	Life Satisfaction A 3 months	Life Satisfaction A 6 months	Life Satisfaction A 9 months	Life Satisfaction A 12 months
Arm 1	13.83	12.67	13.70	14.75	15.17
Arm 2	12.08	12.11	14.44	13.44	12.5
Arm 3	11.35	12.27	11.20	11.57	12.17
Arm 4	12.69	14.13	13.54	13.17	13.83

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Hematocrit

Hematocrit was assessed as a part of routine blood analysis at the indicated time points. (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	% volume (Mean)
	hematocrit baseline %	change hematocrit 3 months %	change hematocrit 6 months %	change hematocrit 9 months %	change hematocrit 12 months %
Arm 1	42.6	3.6	4.044	4.071	5.22
Arm 2	41.2	0.611	0.557	0.63	-1.175
Arm 3	42.0	4.593	4.331	3.38	4.173
Arm 4	40.3	-0.06	0.514	-0.155	-0.192

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Grip Strength kg

Grip strength in the dominant arm will be measured by using a dynamometer. Testing will be performed at baseline, after 3, 6, 9 and 12 months of treatment. (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	kg (Mean)
	grip strength baseline kg	change grip strength 3 month kg	change grip strength 6 month kg	change grip strength 9 month kg	change grip strength 12 month kg
Testosterone Finasteride	18.2	0.485	1.00	1.331	1.174
Testosterone Vehicle	17.0	1.66	2.02	1.558	1.909
Vehicle Finasteride	16.9	-0.045	0.812	1.25	1.477
Vehicle Placebo	17.472	0.212	-0.035	0.152	0.72

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Geriatric Depression Scale

"Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0 = no depressive symptoms The maximum score is 15 = a very high level of depressive symptoms" (NCT00475501)
Timeframe: baseline, 3 months, 6 months, 9 months, 12 months

,,,

Intervention	units on a scale (Mean)
	depression baseline	depression 3 months	depression 6 months	depression 9 months	depression 12 months
Testosterone Finasteride	4.93	3.23	5.0	3.69	3.73
Testosterone Vehicle	2.38	1.80	1.5	0.88	3.33
Vehicle Finasteride	3.08	2.90	2.22	1.89	2.88
Vehicle Placebo	2.13	1.67	1.62	2.92	1.83

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Prostate-specific Antigen (PSA)

PSA level week 10 end of treatment (NCT00490555)
Timeframe: 10 weeks

Intervention	ng/mL (Median)
1) Placebo	0.8
2) Testosterone Gel	0.9
3) T Gel +Dutasteride	0.7
4) T Gel+ DMPA	0.4

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Androstenedione (AED)

(NCT00490555)
Timeframe: 10 weeks

Intervention	ng/mL (Median)
1) Placebo	0.9
2) Testosterone Gel	0.9
3) T Gel +Dutasteride	1.8
4) T Gel+ DMPA	0.7

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Dihydrotestosterone (DHT) Concentration

(NCT00490555)
Timeframe: 10 weeks

Intervention	ng/mL (Median)
1) Placebo	0.5
2) Testosterone Gel	1.8
3) T Gel +Dutasteride	0.5
4) T Gel+ DMPA	0.6

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Testosterone Concentration

(NCT00490555)
Timeframe: 10 weeks

Intervention	ng/mL (Median)
1) Placebo	4.0
2) Testosterone Gel	4.4
3) T Gel +Dutasteride	7.0
4) T Gel+ DMPA	1.8

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Dehydroepiandrosterone (DHEA)

(NCT00490555)
Timeframe: 10 weeks

Intervention	ng/mL (Median)
1) Placebo	4.3
2) Testosterone Gel	3.5
3) T Gel +Dutasteride	3.8
4) T Gel+ DMPA	3.2

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Change in Arterial Stiffness

The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist. (NCT00504712)
Timeframe: Baseline, 12 weeks, and 26 weeks

Intervention	index β (Mean)
	Baseline	12 weeks	26 weeks
Active	15.02	14.08	14.01
Placebo	15.08	16.12	12.58

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Change in IMT

Progression of Carotid intima-media thickness measured in mm (NCT00504712)
Timeframe: Baseline, 12 weeks, and 26 weeks

Intervention	mm (Mean)
	Baseline	12 weeks	26 weeks
Active	0.856	0.843	0.841
Placebo	0.885	0.887	0.872

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Change From Baseline in Sexual Encounter Profile (SEP)

Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Minimum value is 0 with no maximum limit, wherein higher values representing better sexual encounter. (NCT00512707)
Timeframe: Week 0, week 8, week 14

Intervention	events/week (Mean)
	Sexual Encounter Attempts at week 0	Sexual Encounter Attempts at week 8	Sexual Encounter Attempts at week 14	Vaginal Penetration at week 0	Vaginal Penetration at week 8	Vaginal Penetration at week 14	Ejaculation at week 0	Ejaculation at week 8	Ejaculation at week 14	Overall Satisfied with Sexual Encounters at week0	Overall Satisfied with Sexual Encounters at week8	Overall Satisfied with Sexual Encounters at wk 14
Placebo	3.0	3.0	3.0	2.6	2.7	2.6	2.2	2.5	2.3	1.9	2.3	2.5
Testosterone	2.8	2.8	3.3	2.7	2.4	2.7	2.1	2.3	2.6	2.0	2.2	2.8

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Change From Baseline in Sex Hormone Binding Globulin (SHBG)

(NCT00512707)
Timeframe: Week 0, Week 14

Intervention	nmol/L (Mean)
	SHBG at week 0	SHBG at week 14
Placebo	27.5	28
Testosterone	32.2	32

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Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)

The Quality of Life for men with Erection Difficulties (QOL-MED) is a cross-cultural instrument to measure quality of life specific to male erection difficulties. The 18 items for this scale were generated from interviews with men with erection difficulties by TH Wagner in 1996. Higher QOL-MED scores reflect better quality of life. Scores were standardized to range of 0 to 100. (NCT00512707)
Timeframe: Week 0, Week 8, Week 14

Intervention	units on a scale (Mean)
	QOL-MED scale at week 0	QOL-MED scale at week 8	QOL-MED scale at week 14
Placebo	62	70	69
Testosterone	56	65	66

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Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)

The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Positive Affects Ratio (PAR), ranging from 0 to 1, is the proportion of total scores (sum of all 8 domains) that is positive (sum of 4 positive domains). Higher PAR represents better affectivity. (NCT00512707)
Timeframe: Week 0, Week 8, Week 14

Intervention	ratios (Mean)
	Positive Affect Ratio at week 0	Positive Affect Ratio at week 8	Positive Affect Ratio at week 14
Placebo	0.76	0.77	0.76
Testosterone	0.75	0.76	0.78

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Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)

Intervention	units on a scale (Mean)
	Orgasmic function at week 0	Orgasmic function at week 8	Orgasmic function at week 11	Orgasmic function at week 14	Sexual desire at week 0	Sexual desire at week 8	Sexual desire at week 11	Sexual desire at week 14	Intercourse satisfaction at week 0	Intercourse satisfaction at week 8	Intercourse satisfaction at week 11	Intercourse satisfaction at week 14	Overall satisfaction at week 0	Overall satisfaction at week 8	Overall satisfaction at week 11	Overall satisfaction at week 14	Composite IIEF at week 0	Composite IIEF at week 8	Composite IIEF at week 11	Composite IIEF at week 14
Placebo	7.0	7.8	7.4	7.4	6.7	7.0	6.8	6.8	9.4	9.8	9.5	8.8	6.6	7.3	7.0	7.0	50	53	51	50
Testosterone	7.0	7.6	7.9	7.9	6.5	7.0	7.1	7.0	9.5	10.1	10.6	10.0	6.4	6.8	7.4	6.7	47	53	56	53

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Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)

MSHQ, a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). A composite score is the sum of Ejaculation and Satisfaction domains, ranging from 7 to 65 (best), with higher score representing better sexual function and satisfaction. (NCT00512707)
Timeframe: Week 0, Week 8, Week 14

Intervention	units on a scale (Mean)
	Erectile at week 0	Erectile at week 8	Erectile at week 14	Ejaculation at week 0	Ejaculation at week 8	Ejaculation at week 14	Sexual satisfaction at week 0	Sexual satisfaction at week 8	Sexual satisfaction at week 14	Sexual desire at week 0	Sexual desire at week 8	Sexual desire at week 14	Sexual activity at week 0	Sexual activity at week 8	Sexual activity at week 14	Composite MSHQ at week 0	Composite MSHQ at week 8	Composite MSHQ at week 14
Placebo	5.9	6.9	7.2	26.1	27.8	26.9	21.6	22.4	21.5	10.3	10.7	10.1	6.7	6.9	6.5	47.7	50.2	48.5
Testosterone	5.3	6.3	6.9	26.8	28.3	28.4	22.1	22.3	22.5	9.9	10.5	10.5	7.0	7.1	7.0	48.8	50.6	51.1

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Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)

CAncer Rehabilitation Evaluation System-short form (CARES-SF) marital interaction scale consists of 6 items (range from 0 (best) to 4) and mean of these 6 questions was used to determine intimacy and partner interaction. Lower CARES-SF scores correspond with improved marital interaction. (NCT00512707)
Timeframe: Week 0, Week 8, Week 14

Intervention	units on a scale (Mean)
	CARES-SF: Marital relationship at week 0	CARES-SF: Marital relationship at week 8	CARES-SF: Marital relationship at week 14
Placebo	0.74	0.79	0.79
Testosterone	0.79	0.86	0.81

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Change From Baseline in Free Testosterone

Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end. (NCT00512707)
Timeframe: Week 0, Week 14

Intervention	pg/mL (Mean)
	Free Testosterone at week 0	Free Testosterone at week 14
Placebo	101	103
Testosterone	110	239

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Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)

IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function. (NCT00512707)
Timeframe: Week 0, week 8, week 11, week 14

Intervention	units on a scale (Mean)
	Erectile function at week 0	Erectile function at week 8	Erectile function at week 11	Erectile function at week 14
Placebo	20.1	21.3	20.1	19.8
Testosterone	19.6	21.3	22.5	21.7

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Change From Baseline in Derogatis Affects Balance Scale (DABS)

The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Each domain was calculated as the sum of 5-items and could range from 0 to 20, wherein higher scores indicate greater affectivity. (NCT00512707)
Timeframe: Week 0, Week 8, Week 14

Intervention	units on a scale (Mean)
	Joy at week 0	Joy at week 8	Joy at week 14	Contentment at week 0	Contentment at week 8	Contentment at week 14	Vigor at week 0	Vigor at week 8	Vigor at week 14	Affection at week 0	Affection at week 8	Affection at week 14	Depression at week 0	Depression at week 8	Depression at week 14	Anxiety at week 0	Anxiety at week 8	Anxiety at week 14	Guilt at week 0	Guilt at week 8	Guilt at week 14	Hostility at week 0	Hostility at week 8	Hostility at week 14
Placebo	13.1	13.5	12.7	13.2	13.7	12.8	12.0	13.0	12.6	14.6	14.7	14.5	3.9	4.3	4.1	5.5	5.6	5.8	4.1	4.5	3.7	4.3	4.6	4.4
Testosterone	12.7	13.1	13.2	12.8	13.4	13.3	11.8	12.5	12.6	13.9	14.2	14.2	4.1	4.1	4.2	4.9	5.1	4.9	3.4	3.7	3.8	4.7	4.6	4.7

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Change From Baseline in Psychological General Well-Being Index Score (PGWBI)

Well-being and mood were assessed using the Psychological General Well-Being Index (PGWBI), a 22-item questionnaire that evaluated six dimensions of self-reported wellness: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). Higher scores in each dimension reflect increasing well-being. A global score (ranging from 0 (poor QoL) to 110 (good QoL)) was calculated as the sum of each domain score. The global score and those of its 6 dimensions were normalized to a 100% scale to facilitate comparison. (NCT00512707)
Timeframe: Week 0, Week 8, Week 14

Intervention	units on a scale (Mean)
	Positive Well-being at week 0	Positive Well-being at week 8	Positive Well-being at week 14	Depressed Mood at week 0	Depressed Mood at week 8	Depressed Mood at week 14	General Health at week 0	General Health at week 8	General Health at week 14	Anxiety at week 0	Anxiety at week 8	Anxiety at week 14	Self Control at week 0	Self Control at week 8	Self Control at week 14	Vitality at week 0	Vitality at week 8	Vitality at week 14	Global Score at week 0	Global Score at week 8	Global Score at week 14
Placebo	63	63	60	86	86	83	74	75	70	76	76	72	84	86	84	68	69	67	74	75	72
Testosterone	60	65	64	86	85	85	72	73	72	76	76	77	86	86	87	66	68	69	73	75	75

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Change From Baseline in Total Testosterone

Total testosterone levels were measured between 7:30 and 10:10 a.m. using a liquid chromatography-tandem mass spectrometry assay certified by the Centers for Disease Control and Prevention's Hormone Standardization Program. (NCT00512707)
Timeframe: Week 0, Week 14

Intervention	ng/dL (Mean)
	Total Testosterone at week 0	Total Testosterone at week 14
Placebo	347	339
Testosterone	364	649

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Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)

Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Higher percentage of Ejaculations or Satisfaction in successful sexual intercourse represents better sexual function. (NCT00512707)
Timeframe: Week 0, week 8, week 14

Intervention	percentage of sexual intercourses (Mean)
	Successful Sexual Intercourse (Ejaculations) wk0	Successful Sexual Intercourse (Ejaculations) wk8	Successful Sexual Intercourse (Ejaculations)wk14	Successful Sexual Intercourse (Satisfaction) wk0	Successful Sexual Intercourse (Satisfaction) wk8	Successful Sexual Intercourse (Satisfaction)wk14
Placebo	74	84	79	67	75	83
Testosterone	76	78	80	69	76	83

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Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90

Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL (NCT00522431)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90

Intervention	percentage of participants (Number)
	≤1500 ng/dL	1800-2500 ng/dL	>2500 ng/dL
Fortigel	94.6	1.6	0

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Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90

Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL (NCT00522431)
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90

Intervention	percentage of participants (Number)
Fortigel	77.5

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Behavioral & Mood Measure: Profile of Mood States (POMS)

Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline. (NCT00539305)
Timeframe: Baseline, 3 and 6 months

Intervention	units on a scale (Mean)
	Baseline	Month 3 (Change from Baseline)	Month 6 (Change from Baseline)
Placebo Group	55.5	-0.1	-0.5
Treatment Group	57.7	-4.5	1.9

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Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test

Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline. (NCT00539305)
Timeframe: Baseline, 3 and 6 months

Intervention	units on a scale (Mean)
	Baseline	Month 3 (Change from Baseline)	Month 6 (Change from Baseline)
Placebo Group	4.9	0.0	1.5
Treatment Group	6.2	2.3	0.9

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Geriatric Depression Scale (GDS)

Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline. (NCT00539305)
Timeframe: Baseline, Month 3, Month 6

Intervention	units on a scale (Mean)
	Baseline	Month 3 (Change from Baseline)	Month 6 (Change from Baseline)
Placebo Group	4.1	2.3	2.7
Treatment Group	7.2	0.7	-2.8

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Short-Form Health Survey (SF-36)

Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale. (NCT00539305)
Timeframe: Baseline, Month 3, Month 6

Intervention	units on a scale (Mean)
	Baseline	Month 3 (Change from Baseline)	Month 6 (Change from Baseline)
Placebo Group	85.6	-3.8	-5.4
Treatment Group	70.7	15.0	6.4

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Response

Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable. (NCT00586898)
Timeframe: 6 months

Intervention	participants (Number)
	Complete Response (CR)	Partial Response (PR)	Stable Disease (SD)
All Participants	22	4	3

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PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy

(NCT00587431)
Timeframe: Conclusion of the study (at 6 months then at 18 months post-treatment)

,,,

Intervention	participants (Number)
	at 6 months post-treatment	at 18 months post-treatment
Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)	12	2
Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)	14	0
Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)	9	0
Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)	13	3

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The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.

Docetaxel Pharmacokinetic parameters for cycles 1 and 2. (NCT00587431)
Timeframe: at Cycle 1 and 2

Intervention	L/hr (Mean)
	Docetaxel clearance (Cycle 1)	Docetaxel clearance (Cycle 2)
All Participants	23.9	23.6

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Area Under the Curve-Serum T

(NCT00663793)
Timeframe: 14 days

Intervention	nmol*h/L (Mean)
	external matrix 'immediate' release	external matrix 'fast' release	external matrix 'slow' release
Testosterone Only	143	144	162
Testosterone Plus Finasteride	198	384	237

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Area Under the Curve-E2

(NCT00663793)
Timeframe: 14 Days

Intervention	nmol*h/L (Mean)
	external matrix 'immediate' release	external matrix 'fast' release	external matrix 'slow' release
Testosterone Only	1812	1961	1944
Testosterone Plus Finasteride	2241	2002	3129

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Area Under the Curve-serum DHT

(NCT00663793)
Timeframe: 14-days

Intervention	nmol*h/L (Mean)
	external matrix 'immediate' release	external matrix 'fast' release	external matrix 'slow' release
Testosterone Only	36	42	39
Testosterone Plus Finasteride	23	26	26

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Montgomery-Asberg Depression Rating Scale (MADRS) Scale

the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe). (NCT00676676)
Timeframe: Baseline, 2-week, 8-week

Intervention	units on a scale (Mean)
	Baseline visit	2-week visit	8-week visit
Testosterone	25.9	14.7	15.2

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Insulin Sensitivity

As measured by change in insulin levels pre- and post-hormone changes (NCT00680797)
Timeframe: 6 weeks

Intervention	micro International Units/mL (Mean)
+T +E	-0.16
+T -E	2.62
-T +E	-0.50
-T -E	1.83

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Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)

Sampling to determine serum T AUC post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T AUC with food (Day 7) and fasting (Day 8) in Treatment Period 3. (NCT00695110)
Timeframe: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses

Intervention	(ng•hr/dL) (Mean)
	AUC (0-12) (AM dose) with food	AUC (0-12) (AM dose) fasting
Treatment Period 3	6217	2894

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Serum Testosterone Average Concentration (Cavg) (ng/dL)

Sampling to determine serum T Cavg post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T Cavg post AM dose with food (Day 7) and fasting (Day 8) in Treatment Period 3. (NCT00695110)
Timeframe: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses

Intervention	ng/dL (Mean)
	Cavg (0-24)	Cavg (AM dose) with food	Cavg (PM dose) with food
Treatment Period 1	792	765	819
Treatment Period 2	654	657	651
Treatment Period 4	541	533	548

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Serum Testosterone Average Concentration (Cavg) (ng/dL)

Intervention	ng/dL (Mean)
	Cavg (AM dose) with food	Cavg (AM dose) fasting
Treatment Period 3	518	241

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Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)

Intervention	(ng•hr/dL) (Mean)
	AUC (0-24)	AUC (0-12) (AM dose) with food	AUC (12-24) (PM dose) with food
Treatment Period 1	19009	9179	9830
Treatment Period 2	15693	7881	7812
Treatment Period 4	12980	6601	2894

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Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range

Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range. (NCT00698035)
Timeframe: 12 Weeks

Intervention	participants (Number)
Estring	0
Testosterone Cream	4

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Total Testosterone Levels

By serum ultrasensitive total testosterone test (Quest Diagnostics) (NCT00698035)
Timeframe: 12 weeks

Intervention	ng/dl (Mean)
	Testosterone at baseline	Testosterone at 4 weeks	Testosterone at 12 weeks
Testosterone Cream	33	186	171

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Sexual Satisfaction

"Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked Overall, how satisfactory to you is your sexual relationship with your partner? Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory)." (NCT00698035)
Timeframe: Baseline, Week 4, Week 12

Intervention	units on a scale (Mean)
	SS (BL)	SS (W4)	SS (W12)
Estring	2.5	3.5	4.0
Testosterone Cream	3.2	3.7	4.0

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Sexual Quality of Life

Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty. (NCT00698035)
Timeframe: Baseline, Week 4, Week 12

Intervention	units on a scale (Mean)
	SI (BL)	SI (W4)	SI (W12)	SD (BL)	SD (W4)	SD (W12)
Estring	1.2	1.3	0.9	2.9	2.4	2.0
Testosterone Cream	1.4	1.2	1.0	2.9	2.1	1.9

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Matched E2 by Commercial and Research (RIA) Analyses

Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women (NCT00698035)
Timeframe: baseline, 4 weeks

Intervention	pg/ml (Mean)
	Baseline E2	4-week E2
E2 by LC/MS	17.7	7.8
E2 by RIA	17.9	2.9

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Serum Estradiol (E2)

serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics) (NCT00698035)
Timeframe: 12 weeks

Intervention	pg/ml (Mean)
	E2 at baseline	E2 at 4 weeks	E2 at 12 weeks
Estring	27	5	9
Testosterone Cream	9	10	8

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Change in Vaginal Epithelium Scores

During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes. (NCT00698035)
Timeframe: Baseline, 12 weeks

Intervention	units on a scale (Mean)
	Rugae	Pallor	Petechiae	Mucosal thinning	Dryness
Estring	-1.03	-0.88	-1.0	-0.62	-1.03
Testosterone Cream	-0.71	-0.91	-0.74	-0.88	-0.71

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Change From Baseline to Endpoint in Haemoglobin

(NCT00702650)
Timeframe: Baseline, up to Day 120

Intervention	g/dL (Mean)
Testosterone MD-Lotion	0.51

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Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)

(NCT00702650)
Timeframe: Baseline, Day 120

Intervention	ng/mL (Mean)
Testosterone MD-Lotion	0.13

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Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120

Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL). (NCT00702650)
Timeframe: Day 120

Intervention	percentage of participants (Number)
Testosterone MD-Lotion	84.1

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Percentage of Participants With Cmax >2500 ng/dL

Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120. (NCT00702650)
Timeframe: Day 120

Intervention	percentage of participants (Number)
Testosterone MD-Lotion	0.7

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Percentage of Participants With Cmax Between 1800 and 2500 ng/dL

Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120. (NCT00702650)
Timeframe: Day 120

Intervention	percentage of participants (Number)
Testosterone MD-Lotion	3.0

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Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL

Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120. (NCT00702650)
Timeframe: Day 120

Intervention	percentage of participants (Number)
Testosterone MD-Lotion	5.2

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Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL

Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120. (NCT00702650)
Timeframe: Day 120

Intervention	percentage of participants (Number)
Testosterone MD-Lotion	64.4

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Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

(NCT00702650)
Timeframe: Baseline, up to Day 120

Intervention	mIU/mL (Mean)
	Luteinizing Hormone (N=48)	Follicle Stimulating Hormone (N=54)
Testosterone MD-Lotion	-2.04	-2.41

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Change From Baseline to Endpoint in Psychosexual Daily Questionnaire

Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35). (NCT00702650)
Timeframe: Baseline, Day 120

Intervention	units on a scale (Mean)
	Sexual Desire	Overall Sexual Activity Score	Erection Maintained for Satisfactory Duration	Positive Mood	Negative Mood
Testosterone MD-Lotion	1.49	0.94	1.11	0.56	-0.50

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Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). (NCT00702650)
Timeframe: Baseline, Day 120

Intervention	units on a scale (Mean)
	Physical Component Score	Mental Component Score
Testosterone MD-Lotion	1.55	4.54

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Change From Baseline to Endpoint in Draize Score

Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8. (NCT00702650)
Timeframe: Baseline, Day 120

Intervention	units on a scale (Mean)
Testosterone MD-Lotion	0

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Change From Baseline to Endpoint in Estradiol

(NCT00702650)
Timeframe: Baseline, up to Day 120

Intervention	pg/mL (Mean)
Testosterone MD-Lotion	-2.16

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Change From Baseline to Endpoint in Fasting Glucose

(NCT00702650)
Timeframe: Baseline, up to Day 120

Intervention	mg/dL (Mean)
Testosterone MD-Lotion	-0.41

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Change From Baseline to Endpoint in Fasting Insulin

(NCT00702650)
Timeframe: Baseline, up to Day 120

Intervention	uIU/mL (Mean)
Testosterone MD-Lotion	1.93

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Change From Baseline to Endpoint in Haematocrit

Haematocrit: percentage of total blood volume made up of blood cells (NCT00702650)
Timeframe: Baseline, up to Day 120

Intervention	percentage of red blood cells (Mean)
Testosterone MD-Lotion	0.02

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Luteinizing Hormone (LH) Levels

LH levels were measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Intervention	mIU/mL (Mean)
	Baseline	Month 3	Month 6	Follow-Up (Month 7)
Group A Testim	3.40	0.88	0.60	2.68
Group B Androxal no Wash Out	2.92	5.70	6.12	2.47

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Motile Total Sperm Count

Motile total sperm count was measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Intervention	millions sperm (Mean)
	Baseline	Month 3	Month 6	Follow-Up (Month 7)
Group A Testim	0.3	2.42	40.4	38
Group B Androxal no Wash Out	99.0	214.7	146.9	100.3

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Semen Volume

Semen volume was measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Intervention	mL (Mean)
	Baseline	Month 3	Month 6	Follow-Up (Month 7)
Group A Testim	2.34	2.88	1.90	3.34
Group B Androxal no Wash Out	2.23	2.45	2.48	2.40

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Sperm Concentration

Total sperm concentration was measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Intervention	millions sperm/mL (Mean)
	Baseline	Month 3	Month 6	Follow-Up (Month 7)
Group A Testim	0.54	3.00	23.14	21.03
Group B Androxal no Wash Out	72.8	182.6	168.5	164.0

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Follicle Stimulating Hormone (FSH) Levels

FSH levels were measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Intervention	mIU/mL (Mean)
	Baseline	Month 3	Month 6	Follow-Up (Month 7)
Group A Testim	3.38	1.06	0.9	3.6
Group B Androxal no Wash Out	1.58	4.53	5.48	2.38

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Estradiol Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	pmol/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	95.4	31.9
Group 2: Acyline, Testosterone Gel	117.8	109.0
Group 3: Acyline, Testosterone Gel, Anastrozole Pill	96.3	36.5

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Endothelial Progenitor Cells

Number of CD33 + CD134+ cells as a percentage of all lymphocytes (NCT00729859)
Timeframe: Baseline, Day 28

Intervention	percentage of all lymphocytes (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel + Placebo Pill	0.101	0.081

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Fasting Serum Insulin

(NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	picomolar (Mean)
	Baseline	Day 28	Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	54	69	54
Group 2: Acyline, Testosterone Gel, Placebo Pill	65	59	64
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	50	42	50

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Sex Hormone Binding Globulin (SHBG)

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	nmol/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	34.9	37.5
Group 2: Acyline, Testosterone Gel	23.0	22.1
Group 3: Acyline, Testosterone Gel, Anastrozole Pill	27.6	25.1

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Fasting Lipid Levels

(NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	mmol/L (Mean)
	Total cholesterol Day 0	Total cholesterol Day 28	Total cholesterol Day 56	LDL choesterol Day 0	LDL cholesterol Day 28	LDL cholesterol Day 56	HDL cholesterol Day 0	HDL cholesterol Day 28	HDL cholesterol Day 56	Triglycerides Day 0	Triglycerides Day 28	Triglycerides Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	4.97	5.44	4.95	2.95	3.29	2.87	1.19	1.37	1.19	1.79	1.73	1.89
Group 2: Acyline, Testosterone Gel, Placebo Pill	4.48	4.51	4.14	2.77	2.80	2.49	1.32	1.32	1.32	0.82	0.86	0.80
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	4.56	4.56	4.27	2.67	2.75	2.51	1.40	1.32	1.30	1.08	1.08	1.02

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Follicle Stimulating Hormone (FSH)

(NCT00729859)
Timeframe: Baseline, 28 days

Intervention	IU/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	4.2	0.42
Group 2: Acyline, Testosterone Gel	2.9	0.39
Group 3: Acyline, Testosterone Gel, Anastrazole Pill	2.5	0.87

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Homeostasis Model of Insulin Resistance (HOMA-IR)

HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity. (NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	HOMA score (Mean)
	Baseline	Day 28	Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	1.8	2.4	2.2
Group 2: Acyline, Testosterone Gel, Placebo Pill	2.0	1.9	1.9
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	1.6	1.4	1.7

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Luteinizing Hormone Concentration (LH)

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	IU/L (Mean)
	Baseline	Day 28
Group 1: Acyline + Placebo Gel, Placebo Pill	4.3	0.31
Group 2: Acyline, Testosterone Gel	4.7	0.69
Group 3: Acyline, Testosterone Gel, Anastrozole	4.4	1.55

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Quantitative Insulin Sensitivity Check Index (QUICKI)

QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity. (NCT00729859)
Timeframe: Baseline, Day 28, Day 56

Intervention	QUICKI index (Mean)
	Baseline	Day 28	Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill	0.36	0.34	0.35
Group 2: Acyline, Testosterone Gel, Placebo Pill	0.35	0.35	0.35
Group 3: Acyline, Testosterone Gel, Oral Anastrozole	0.36	0.38	0.36

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Testosterone Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

Intervention	nmol/L (Mean)
	Baseline testosterone concentration	Day 28 testosterone concentration
Group 1: Acyline + Placebo Gel, Placebo Pill	15.4	0.8
Group 2: Acyline, Testosterone Gel	16.3	17.8
Group 3: Acyline, Testosterone Gel, Anastrozole	16.5	19.0

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Meibomian Gland Secretion Appearance at Visit 4 (Day 168)

The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst. (NCT00755183)
Timeframe: 168 days

Intervention	units on a scale (Mean)
Testosterone Ophthalmic Solution	0.80
Vehicle	0.96

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Ocular Discomfort Score at Visit 4

Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168) (NCT00755183)
Timeframe: 168 days

Intervention	score on a scale (Mean)
Testosterone Ophthalmic Solution	1.70
Vehicle	1.33

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Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)

Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	4.0
Placebo Gel	1.1

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Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone

Volumetric Bone Mineral Density (BMD) of spine trabecular bone as measured by QCT, mg/cm3, the calculated change in measurement from baseline to Month 12 (NCT00799617)
Timeframe: 1 year (QCT measurement of BMD change between baseline and month 12)

Intervention	mg/cm^3 (Mean)
AndroGel® (Testosterone Gel)	7.5
Placebo Gel	0.8

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Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)

Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	5.5
Placebo Gel	1.2

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Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline

Coronary artery calcium score in Agatston units (range of 0 to >400 Agatston units), with higher values indicating more severe atherosclerosis). (NCT00799617)
Timeframe: 1 year (change from baseline to month 12)

Intervention	Agatston units (Least Squares Mean)
AndroGel® (Testosterone Gel)	64
Placebo Gel	91

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Cardiovascular Trial - Total Plaque Volume Change From Baseline

Total plaque volume,mm3 measured by coronary computed tomographic angiography (NCT00799617)
Timeframe: 1 year (change from baseline to month 12)

Intervention	mm^3 (Mean)
AndroGel® (Testosterone Gel)	75
Placebo Gel	28

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Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia

"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 g/dL from baseline.~Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline." (NCT00799617)
Timeframe: 1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12)

Intervention	Participants (Count of Participants)
	Month 3	Month 6	Month 9	Month 12
AndroGel® (Testosterone Gel)	6	8	15	13
Placebo Gel	4	3	2	4

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Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)

Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	1.7
Placebo Gel	0.4

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Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume

Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12 (NCT00799617)
Timeframe: 1 year (change in plaque volume measurement from baseline to month 12)

Intervention	mm^3 (Mean)
AndroGel® (Testosterone Gel)	54
Placebo Gel	14

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Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)

"Baseline score and change in score of the Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) test of Delayed Paragraph Recall, at baseline, Month 6 and Month 12.~The WMS-R LM II involves a delayed paragraph recall activity scored in two components, each ranging from 0-25. The final score is the sum of each component, therefore falling in the range 0-50. WMS-R LM II scores were treated as continuous with change compared between treatment arms using linear random effects models adjusting for several factors: site, indicator variables of participation in each primary efficacy trial, baseline testosterone concentration (<200), age (≤ 75), use of anti-depressants, use of PDE-inhibitors, baseline WMSR, categorical education, and version of the WMSR." (NCT00799617)
Timeframe: 1 year (change from baseline to month 6 and month 12)

Intervention	percentage of change in test score (Mean)
	Baseline Score	Change at Month 6	Change at Month 12
AndroGel® (Testosterone Gel)	14.0	1.1	1.3
Placebo Gel	14.4	1.1	1.4

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Cognitive Function Trial - Executive Function - Trail Making Test B - A

"Baseline score and change in score in Executive Function as Measured by Trail-Making Test (TMT) B - A, at baseline, Month 6 and Month 12.~Change in performance on the Trail Making Test was analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version.~Participants are required to connect a set of numbers (Part A) or alternating letters and numbers (Part B) in sequential order. The score for each part is the total time (in seconds) to complete both parts. The outcome analyzed will be the total time for Trails B minus the total time for Trails A to provide a measure of working memory, adjusted for attention and processing speed. Higher scores reflect lower executive function." (NCT00799617)
Timeframe: 1 year (baseline to month 6 to month 12)

Intervention	Score on the Trail Making Test scale (Mean)
	Baseline Score	Change at Month 6	Change at Month 12
AndroGel® (Testosterone Gel)	86.4	-2.1	-0.0
Placebo Gel	76.7	1.8	7.1

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Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)

"Baseline score and change in score in the Spatial Ability Using the Card Rotation Test at baseline, Month 6 and Month 12.~Change in performance on the Card Rotations Test will be analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version. The test consists of a series of 10 primary figures, each of which has 8 corresponding secondary figures. Subjects are asked to determine which of the secondary figures is the same as the corresponding primary figure, and the score is taken as the number of figures answered correctly minus the number of figures answered incorrectly.~The maximum score is 80 for subjects who answer all items correctly." (NCT00799617)
Timeframe: 1 year (baseline to month 6 to month 12)

Intervention	Score on the CRT test scale (Mean)
	Baseline Score	Change at Month 6	Change at Month 12
AndroGel® (Testosterone Gel)	28.7	0.6	0.6
Placebo Gel	30.0	0.2	1.2

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Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)

"Baseline score and mean change in score in the Visual Memory Using the Benton Visual Retention Test (BVRT) from baseline, Month 6 and Month 12.~The BVRT measures short term visual memory and visuo-constructional abilities and was administered and scored according to standard procedures. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score was the total number of figures with errors and ranged from 0 to 26. Scores were inverted to 0 to -26 so that higher scores would reflect better performance.~Change in BVRT scores from baseline are treated as continuous and compared between AAMI Androgel and placebo subjects using linear random effects models adjusting for balancing factors as described in the primary analysis." (NCT00799617)
Timeframe: 1 year (baseline to month 6 and month 12)

Intervention	Score on the BVRT test scale (Mean)
	Baseline Score	Change at Month 6	Change at Month 12
AndroGel® (Testosterone Gel)	-8.2	0.2	0.3
Placebo Gel	-8.2	0.3	0.7

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Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters

Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12 (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	meters (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	347.7	10.2	8.2	5.3	14.3
Placebo Gel	344.9	4.6	7.8	3.2	5.5

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Physical Function Trial - PF 10 Overall Score

"Baseline score and the change in score on the physical-function scale (PF-10) of the Medical Outcomes Study 36-Item Short Form Health Survey range from 0 to 100, with higher scores indicating better function.~Scores were measured as the change from baseline to Month 12." (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the PF-10 test scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	65.4	5.6	6.5	5.9	5.8
Placebo Gel	64.8	4.2	4.8	3.3	2.4

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Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)

The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters. (NCT00799617)
Timeframe: 1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)

Intervention	Participants (Count of Participants)
	Month 3	Month 6	Month 9	Month 12
AndroGel® (Testosterone Gel)	20	24	28	35
Placebo Gel	14	23	22	20

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Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)

The number of participants whose score on the physical-function domain (PF-10; range, 0 to 100, with higher scores indicating better function) of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) increased by at least 8 points from baseline to Month 12. (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Participants (Count of Participants)
	Month 3	Month 6	Month 9	Month 12
AndroGel® (Testosterone Gel)	77	72	77	66
Placebo Gel	59	73	60	58

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Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12

"Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12.~Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.~The change is measured form the baseline value to Month 12." (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	units on the PDQ-Q4 scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	1.4	0.6	0.6	0.5	0.2
Placebo Gel	1.4	0.1	-0.1	-0.1	-0.1

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Sexual Function Trial - Erectile Function

"Baseline score and the change in score on the International Index of Erectile Function (IIEF) from baseline to Month 12.~Scores on the IIEF range from 0-30, with higher scores indicating better function." (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the IIEF test scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	8.0	3.4	3.3	3.4	3.1
Placebo Gel	7.7	1.0	0.5	0.5	1.0

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Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N

Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	1.4
Placebo Gel	0.4

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Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.

"Baseline score and change in the total positive affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.~Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect." (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the PANAS test scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	15.3	0.7	0.9	0.9	0.7
Placebo Gel	15.4	0.3	0.0	0.4	0.2

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Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12

"Baseline score and change in the total negative affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.~Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect." (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the PANAS test scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	7.5	-0.2	-0.4	-0.2	-0.6
Placebo Gel	7.4	0.3	0.4	-0.1	-0.1

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Vitality Trial - FACIT Fatigue Overall Score

Baseline score and change in the FACIT- Fatigue score from baseline to Month 12. Scores on the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale range from 0 to 52, with higher scores indicating less fatigue. (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the FACIT- Fatigue test scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	31.6	7.8	7.4	8.6	8.0
Placebo Gel	31.3	7.2	5.9	7.2	6.7

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Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)

"The number of participants whose score on the FACIT-Fatigue scale increased by at least 4 points.~Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue." (NCT00799617)
Timeframe: 1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)

Intervention	Participants (Count of Participants)
	Month 3	Month 6	Month 9	Month 12
AndroGel® (Testosterone Gel)	148	144	148	147
Placebo Gel	138	126	127	120

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Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)

"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 gm/dL from baseline.~Values are means (SDs) for continuous outcomes." (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	proportion of participants (Mean)
AndroGel® (Testosterone Gel)	0.9
Placebo Gel	0.2

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Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score

"Baseline score and change in score in the Patient Health Questionnaire 9 (PHQ-9) from baseline to Month 12.~Scores on the Patient Health Questionnaire 9 (PHQ-9) depression scale range from 0 to 27, with higher scores indicating greater intensity of depressive symptoms." (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the PHQ-9 test scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	6.6	-1.3	-1.7	-1.9	-1.8
Placebo Gel	6.6	-0.8	-0.5	-1.2	-1.1

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Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)

Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	1.2
Placebo Gel	0.5

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Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)

Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	3.3
Placebo Gel	2.1

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Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)

Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	1.5
Placebo Gel	0.9

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Vitality Trial - SF-36 Score

Baseline score and change in the SF-36 Vitality Score from baseline to Month 12 Scores on the vitality scale of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating less fatigue. (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the SF-36 vitality scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	50.6	7.4	7.2	8.4	8.2
Placebo Gel	49.4	5.9	4.5	5.7	6.1

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Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N

Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	1.5
Placebo Gel	0.5

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Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N

Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	2.5
Placebo Gel	0.6

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Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N

Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	7.2
Placebo Gel	1.5

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Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N

Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	10.8
Placebo Gel	2.4

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Sexual Function Trial - Sexual Desire Domain

"Baseline score and the changes in the score of the sexual-desire domain of the Derogatis Interview for Sexual Functioning in Men-II (DISF-M-II), from baseline to Month 12.~Scores on the (DISF-M-II) range from 0 to 33, with higher scores indicating greater sexual desire." (NCT00799617)
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)

Intervention	Score on the DISF-M-II scale (Mean)
	Baseline Score	Change at Month 3	Change at Month 6	Change at Month 9	Change at Month 12
AndroGel® (Testosterone Gel)	11.9	3.5	3.5	4.0	2.6
Placebo Gel	11.6	0.7	0.8	0.9	0.0

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Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N

Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	9.0
Placebo Gel	1.9

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Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)

Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	1.6
Placebo Gel	0.7

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Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)

Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) (NCT00799617)
Timeframe: 1 year (baseline to month 12)

Intervention	percentage of change (Mean)
AndroGel® (Testosterone Gel)	1.6
Placebo Gel	0.1

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Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis

"The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of [5,5,5-2H3]leucine into muscle proteins. [5,5,5-2H3]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model.~The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour." (NCT00805207)
Timeframe: Before and at the end of the intervention

,,,,,,

Intervention	%/h (Mean)
	Before	After
Control	0.064	0.067
Estrogen	0.063	0.063
Glucocorticoid	0.059	0.061
Progesterone - PCOS	0.049	0.083
Progesterone - Postmenopausal Women	0.054	0.085
Testosterone - Postmenopausal Women	0.056	0.079
Testosterone - Premenopausal Women	0.064	0.092

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Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration

VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO). (NCT00805207)
Timeframe: Before and at the end of the interventions

Intervention	mmol/L (Mean)
	Before
Control - Baseline Testing Only	0.32

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Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration

,,,,,,,

Intervention	mmol/L (Mean)
	Before	After
Continuous Positive Airway Pressure	0.50	0.64
Control	0.30	0.28
Estrogen	0.50	0.35
Glucocorticoid	0.35	0.33
Progesterone - PCOS	0.75	1.03
Progesterone - Postmenopausal Women	0.42	0.44
Testosterone - Postmenopausal Women	0.18	0.18
Testosterone - Premenopausal Women	0.31	0.40

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Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate

VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration. (NCT00805207)
Timeframe: Before and at the end of interventions

Intervention	umol/min/L plasma (Mean)
	Before
Control - Baseline Testing Only	3.53

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VLDL-TG Plasma Clearance Rate (Means)

VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. (NCT00805207)
Timeframe: Before and at the end of the interventions

Intervention	mL/min (Mean)
	Before
Control - Baseline Testing Only	33.1

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Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate

,,,,,,,

Intervention	umol/min/L plasma (Mean)
	Before	After
Continuous Positive Airway Pressure	2.87	3.94
Control	2.47	2.57
Estrogen	2.87	2.94
Glucocorticoid	3.80	3.42
Progesterone - PCOS	4.66	7.77
Progesterone - Postmenopausal Women	3.36	3.24
Testosterone - Postmenopausal Women	2.03	2.11
Testosterone - Premenopausal Women	3.13	3.00

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VLDL-TG Plasma Clearance Rate (Medians)

VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. (NCT00805207)
Timeframe: Before and at the end of the interventions

,,,,,,,

Intervention	mL/min (Median)
	Before	After
Continuous Positive Airway Pressure	19.1	20.8
Control	19.6	22.3
Estrogen	14.4	24.2
Glucocorticoid	35.8	27.4
Progesterone - PCOS	20.3	20.3
Progesterone - Postmenopausal Women	20.8	22.8
Testosterone - Postmenopausal Women	32.1	32.7
Testosterone - Premenopausal Women	40.6	43.6

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VLDL-TG Plasma Clearance Rate (Medians)

VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. (NCT00805207)
Timeframe: Before and at the end of the interventions

Intervention	mL/min (Median)
	Before
Control - Baseline Testing Only	33.4

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VLDL-TG Plasma Clearance Rate (Means)

VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. (NCT00805207)
Timeframe: Before and at the end of the interventions

,,,,,,,

Intervention	mL/min (Mean)
	Before	After
Continuous Positive Airway Pressure	19.1	20.8
Control	22.6	23.3
Estrogen	17.4	25.1
Glucocorticoid	33.8	34.3
Progesterone - PCOS	20.3	24.6
Progesterone - Postmenopausal Women	21.2	24.9
Testosterone - Postmenopausal Women	35.1	34.5
Testosterone - Premenopausal Women	42.2	58.1

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Intratesticular Testosterone (ITT-T)

(NCT00839319)
Timeframe: 10 days

Intervention	IU/L (Median)
Acyline Plus Placebo	77
Acyline Plus 15 IU hCG	136
Acyline Plus 60 IU hCG	319
Acyline Plus 125 IU hCG	987
Acyline Plus Testosterone Gel	73

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Serum Follicle Stimulating Hormone (FSH)

(NCT00839319)
Timeframe: 10 days

Intervention	IU/L (Median)
Acyline Plus Placebo	0.41
Acyline Plus 15 IU hCG	0.41
Acyline Plus 60 IU hCG	0.29
Acyline Plus 125 IU hCG	0.28
Acyline Plus Testosterone Gel	0.21

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Serum Luteinizing Hormone (LH)

(NCT00839319)
Timeframe: 10 days

Intervention	IU/L (Median)
Acyline Plus Placebo	0.13
Acyline Plus 15 IU hCG	0.28
Acyline Plus 60 IU hCG	0.49
Acyline Plus 125 IU hCG	0.39
Acyline Plus Testosterone Gel	0.14

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Serum Testosterone (T)

(NCT00839319)
Timeframe: 10 days

Intervention	nmol/liter (Median)
Acyline Plus Placebo	0.43
Acyline Plus 15 IU hCG	1.5
Acyline Plus 60 IU hCG	3.7
Acyline Plus 125 IU hCG	8.4
Acyline Plus Testosterone Gel	16

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Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.

There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function (NCT00848497)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Number)
Placebo Testim + Viagra	1

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Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.

"ADAM scores of one evaluated patient. ADAM is 10 questions (yes or no answers) and if you answer yes to question 1 or 7 or yes to any 3 questions you are said to test positive to the ADAM questionnaire." (NCT00848497)
Timeframe: Baseline and 6 months

Intervention	number of yes answers (Number)
Placebo Testim + Viagra	1

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Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.

SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED (NCT00848497)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Number)
Placebo Testim + Viagra	0

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Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.

EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better (NCT00848497)
Timeframe: Basline and 6 months

Intervention	units on a scale (Number)
Placebo Testim + Viagra	-11

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Change From Baseline MTE08 to MTE09 Follow-up in Estradiol

(NCT00857454)
Timeframe: Day 1, up to Day 190

Intervention	picograms per milliliter (pg/mL) (Mean)
Testosterone MD-lotion	2.76

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Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

(NCT00857454)
Timeframe: Day 1, up to Day 190

Intervention	mIU/mL (Mean)
	LH (N=50)	FSH (N=58)
Testosterone MD-lotion	-1.39	-1.82

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Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)

(NCT00857454)
Timeframe: Day 1, up to Day 190

Intervention	nanograms per milliliter (ng/mL) (Mean)
Testosterone MD-lotion	0.10

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Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin

(NCT00857454)
Timeframe: Day 1, up to Day 190

Intervention	grams per deciliter (g/dL) (Mean)
Testosterone MD-lotion	0.54

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Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit

(NCT00857454)
Timeframe: Day 1, up to Day 190

Intervention	percentage of red blood cells in sample (Mean)
Testosterone MD-lotion	0.03

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Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin

(NCT00857454)
Timeframe: Day 1, up to Day 190

Intervention	uIU/mL (Mean)
Testosterone MD-lotion	1.43

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Change From Baseline MTE08 to MTE09 Endpoint in Draize Score

Draize score is a measurement of skin irritability of the application site based on erythema/escar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8. (NCT00857454)
Timeframe: Day 1, Day 190

Intervention	units on a scale (Mean)
Testosterone MD-lotion	0.0

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Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose

(NCT00857454)
Timeframe: Day 1, up to Day 190

Intervention	milligrams per deciliter (mg/dL) (Mean)
Testosterone MD-lotion	12.25

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Number of Participants With Adverse Events

A listing of adverse events is located in the Reported Adverse Events module. (NCT00857961)
Timeframe: Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)

,,,

Intervention	participants (Number)
	Serious Adverse Events	Non-Serious Adverse Events
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	0	5
3 mL (30 mg) of 1% Testosterone MD-Lotion	0	4
3 mL (60 mg) of 2% Testosterone MD-Lotion	0	6
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	0	5

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Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours. (NCT00857961)
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

,,,

Intervention	ng/dL (Mean)
	Cmax	Cmin	Cavg (n=21, n=20, n=21, n=21)
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	430	171	294
3 mL (30 mg) of 1% Testosterone MD-Lotion	546	164	338
3 mL (60 mg) of 2% Testosterone MD-Lotion	590	221	389
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	626	238	432

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Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours. (NCT00857961)
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

,,,

Intervention	ng/dL (Mean)
	Cmax	Cmin	Cavg (n=21, n=20, n=21, n=21)
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	69.4	34.6	53.0
3 mL (30 mg) of 1% Testosterone MD-Lotion	90.7	33.3	62.3
3 mL (60 mg) of 2% Testosterone MD-Lotion	96.4	47.8	71.4
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	98.6	49.4	76.5

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Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)

Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours. (NCT00857961)
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

,,,

Intervention	ng/dL (Mean)
	Cmax	Cmin	Cavg n=21, n=20, n=21, n=21)
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	11.3	4.5	7.6
3 mL (30 mg) of 1% Testosterone MD-Lotion	14.6	4.4	8.9
3 mL (60 mg) of 2% Testosterone MD-Lotion	15.9	5.9	10.4
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	16.5	6.4	11.4

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Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)

Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7. (NCT00857961)
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

,,,

Intervention	hours (h) (Median)
	Total Testosterone	Dihydrotestosterone	Free Testosterone
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	12.00	11.93	12.00
3 mL (30 mg) of 1% Testosterone MD-Lotion	8.00	8.00	8.00
3 mL (60 mg) of 2% Testosterone MD-Lotion	4.25	4.25	4.25
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	15.98	15.98	15.98

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Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]

Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7. (NCT00857961)
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

,,,

Intervention	h*ng/dL (Mean)
	Total Testosterone	Dihydrotestosterone	Free Testosterone
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	7053	1271	183
3 mL (30 mg) of 1% Testosterone MD-Lotion	8111	1496	214
3 mL (60 mg) of 2% Testosterone MD-Lotion	9332	1712	250
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	10361	1836	275

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Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)

Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%. (NCT00857961)
Timeframe: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment

,,,

Intervention	percent fluctuation in concentration (Mean)
	Total Testosterone	Dihydrotestosterone	Free Testosterone
1.5 mL (30 mg) of 2% Testosterone MD-Lotion	84	68	84
3 mL (30 mg) of 1% Testosterone MD-Lotion	107	85	107
3 mL (60 mg) of 2% Testosterone MD-Lotion	91	70	91
4.5 mL (90 mg) of 2% Testosterone MD-Lotion	92	65	92

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Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks

Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	20.63
Arm II: Standard of Care Therapy + Testosterone	11.66

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1-year Survival

Number of participants who survived one year post study. (NCT00878995)
Timeframe: 1 year post study

Intervention	Participants (Count of Participants)
Arm I: Standard of Care Therapy + Placebo Testosterone	7
Arm II: Standard of Care Therapy + Testosterone	6

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Body Weight as Measured by Scale at 7 Weeks.

Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication. (NCT00878995)
Timeframe: 7 weeks

Intervention	Kilograms (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	63.93
Arm II: Standard of Care Therapy + Testosterone	62.59

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Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline

Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life). (NCT00878995)
Timeframe: Baseline

Intervention	scores on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	18.83
Arm II: Standard of Care Therapy + Testosterone	30.48

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Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline

Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: Baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	67.02
Arm II: Standard of Care Therapy + Testosterone	260.69

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Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline

The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99. (NCT00878995)
Timeframe: baseline

Intervention	units on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	47.73
Arm II: Standard of Care Therapy + Testosterone	52.22

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Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks

Intervention	Units on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	52.73
Arm II: Standard of Care Therapy + Testosterone	46.50

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Body Weight as Measured by Scale at Baseline

Body weight in kilograms as measured by a scale at the baseline visit. (NCT00878995)
Timeframe: Baseline

Intervention	Kilograms (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	65.98
Arm II: Standard of Care Therapy + Testosterone	63.11

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Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks

Intervention	scores on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	20.11
Arm II: Standard of Care Therapy + Testosterone	24.97

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Physical Activity Levels as Measured by the ActiGraph Accelerometer

Physical activity is reported as % time sedentary for the entire 7 week study. (NCT00878995)
Timeframe: through study completion,up to 7 weeks

Intervention	% time sedentary (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	73.55
Arm II: Standard of Care Therapy + Testosterone	74.74

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Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks

"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue." (NCT00878995)
Timeframe: 7 weeks

Intervention	Units on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	18.73
Arm II: Standard of Care Therapy + Testosterone	26.11

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Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline

Intervention	Units on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	12.73
Arm II: Standard of Care Therapy + Testosterone	21.40

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Mood Measured by Profile of Mood States at Baseline

"Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being not at all' and 4 being extremely. There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best)." (NCT00878995)
Timeframe: baseline

Intervention	units on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	30.73
Arm II: Standard of Care Therapy + Testosterone	32.55

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Mood as Measured by Profile of Mood States at 7 Weeks

Intervention	Units on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	28.82
Arm II: Standard of Care Therapy + Testosterone	35.78

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Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline

Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. (NCT00878995)
Timeframe: Baseline

Intervention	Newton-Meters (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	81.77
Arm II: Standard of Care Therapy + Testosterone	122.50

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Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.

Intervention	Newton-Meters (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	76.75
Arm II: Standard of Care Therapy + Testosterone	118.26

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Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.

Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. (NCT00878995)
Timeframe: Baseline

Intervention	Watts (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	137.60
Arm II: Standard of Care Therapy + Testosterone	169.0

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Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks

Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec. (NCT00878995)
Timeframe: 7 weeks

Intervention	Watts (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	126.93
Arm II: Standard of Care Therapy + Testosterone	157.90

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Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline

Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit (NCT00878995)
Timeframe: baseline

Intervention	grams (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	20513.50
Arm II: Standard of Care Therapy + Testosterone	18227.33

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Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks

Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit. (NCT00878995)
Timeframe: 7 weeks

Intervention	grams (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	17616.58
Arm II: Standard of Care Therapy + Testosterone	16776.60

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Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.

Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported. (NCT00878995)
Timeframe: 7 weeks

Intervention	Percent change (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	-3.31
Arm II: Standard of Care Therapy + Testosterone	1.42

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Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks

Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	64.15
Arm II: Standard of Care Therapy + Testosterone	191.17

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Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline

Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values. (NCT00878995)
Timeframe: Baseline

Intervention	kilo-calories per day (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	1329.20
Arm II: Standard of Care Therapy + Testosterone	1310.81

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Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks

Intervention	kilo-calories per day (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	1338.10
Arm II: Standard of Care Therapy + Testosterone	1260.98

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Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	11.87
Arm II: Standard of Care Therapy + Testosterone	13.88

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Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	33.52
Arm II: Standard of Care Therapy + Testosterone	12.22

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Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: Baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	14.57
Arm II: Standard of Care Therapy + Testosterone	16.62

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Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	11.45
Arm II: Standard of Care Therapy + Testosterone	12.34

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Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: Baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	6.57
Arm II: Standard of Care Therapy + Testosterone	21.61

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Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	9.97
Arm II: Standard of Care Therapy + Testosterone	18.16

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Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	11.04
Arm II: Standard of Care Therapy + Testosterone	43.99

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Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: Baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.02
Arm II: Standard of Care Therapy + Testosterone	14.56

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Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.13
Arm II: Standard of Care Therapy + Testosterone	12.62

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Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	4.30
Arm II: Standard of Care Therapy + Testosterone	3.13

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Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	10.48
Arm II: Standard of Care Therapy + Testosterone	2.35

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Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.62
Arm II: Standard of Care Therapy + Testosterone	3.92

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Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	8.89
Arm II: Standard of Care Therapy + Testosterone	23.09

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Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.02
Arm II: Standard of Care Therapy + Testosterone	2.39

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Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: Baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	2.50
Arm II: Standard of Care Therapy + Testosterone	20.50

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Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.82
Arm II: Standard of Care Therapy + Testosterone	17.95

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Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: Baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.94
Arm II: Standard of Care Therapy + Testosterone	44.04

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Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	4.36
Arm II: Standard of Care Therapy + Testosterone	28.36

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Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	13.35
Arm II: Standard of Care Therapy + Testosterone	94.52

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Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	12.84
Arm II: Standard of Care Therapy + Testosterone	82.46

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Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: Baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.11
Arm II: Standard of Care Therapy + Testosterone	1.98

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Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.

Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: 7 weeks

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	2.13
Arm II: Standard of Care Therapy + Testosterone	1.71

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Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.

Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. (NCT00878995)
Timeframe: baseline

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	21.62
Arm II: Standard of Care Therapy + Testosterone	15.71

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The Number of Men Who Have Azoospermia

(NCT00891228)
Timeframe: 24 Weeks

Intervention	participants (Number)
Testosterone Gel 10 g and Nestorone® 0 mg Per Day	5
Testosterone Gel 10 g and Nestorone® 8 mg Per Day	14
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day	11

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The Impact on Sperm Morphology in Men Who Are Not Azoospermic

(NCT00891228)
Timeframe: 24 weeks

Intervention	percentage normal morphology (Mean)
Testosterone Gel 10 g and Nestorone® 0 mg Per Day	12.3
Testosterone Gel 10 g and Nestorone® 8 mg Per Day	10.8
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day	9.1

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The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.

(NCT00891228)
Timeframe: 24 Weeks

Intervention	percentage of sperm (Mean)
	Percent Progressive (week 24)	Percent Non Progressive (week 24)
Testosterone Gel 10 g and Nestorone® 0 mg Per Day	52.8	10.4
Testosterone Gel 10 g and Nestorone® 8 mg Per Day	31.9	7.4
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day	29.6	8.3

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The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.

(NCT00891228)
Timeframe: 24 Weeks

Intervention	participants (Number)
Testosterone Gel 10 g and Nestorone® 0 mg Per Day	5
Testosterone Gel 10 g and Nestorone® 8 mg Per Day	15
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day	13

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The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.

(NCT00891228)
Timeframe: 24 Weeks

Intervention	participants (Number)
Testosterone Gel 10 g and Nestorone® 0 mg Per Day	5
Testosterone Gel 10 g and Nestorone® 8 mg Per Day	15
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day	14

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Serum T Concentration at Steady State

Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment. (NCT00911586)
Timeframe: pre-dose on Days 1, 3, 5, 6, and 7

Intervention	ng/dL (Least Squares Mean)
Testosterone Undecanoate	-4.077

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Serum T Concentration at Steady-State

Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment. (NCT00911586)
Timeframe: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28

Intervention	ng/dL (Least Squares Mean)
Testosterone Undecanoate	4.114

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Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet

PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25. (NCT00924612)
Timeframe: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.

Intervention	ng/dL (Geometric Mean)
Fasting	6.38
Very Low Fat Diet	6.73
Low Fat Diet	6.88
Normal Diet	7.00
High Fat Diet	7.18

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9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines

Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months (NCT00957528)
Timeframe: 5 months

Intervention	pg/mL (Mean)
	IL-B1 Baseline	IL-B1 Five Months	IL-2 Baseline	IL-2 Five Months	IL-5 Baseline	IL-5 Five Months	IL-6 Baseline	IL-6 Five months	IL-7 Baseline	IL-7 Five Months	IL-8 Baseline	IL-8 Five months	IL-10 Baseline	IL-10 Five Months	IL-12 Baseline	IL-12 Five Months	IL-13 baseline	IL-13 Five Months	IFN gamma Baseline	IFN gamma Five Months	GM-CSF Baseline	GM-CSF Five Months	TNF alpha Baseline	TNF alpha Five Months
Continuous Testosterone	1.44143	2.538	2.538	3.862	1.41875	1.94125	10.4025	13.89	5.19875	16.2763	8.45625	11.8025	109.446	135.64	35.3583	58.4217	60.2125	73.674	23.425	36.822	7.94875	14.965	13.215	15.4138
Monthly Cycled Testosterone	0.475	3.19	3.19	1.45333	0.79	0.32286	4.90857	6.487	11.9688	23.1888	6.66375	4.06286	11.2588	8.34143	4.242	2.66	23.33	12.72	4.58	1.758	2.4	1.312	10.0863	8.1529
Placebo	0.14	0.20833	1.32	2.84	0.6	0.705	5.68375	5.05	8.78	7.68	4.5575	4.3225	22.6363	25.4525	7.075	10.902	37.045	43.465	10.115	36.05	1.52429	2.27857	9.0175	8.14

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Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months

The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-[ring-13C6]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = [(EP2 - EP1)/(EM•t)]•60•100, where EP1 and EP2 are the enrichments of bound L-[ring-13C6]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-[ring-13C6]-phenylalanine enrichment in the muscle intracellular pool. (NCT00957528)
Timeframe: 5 Months

Intervention	Percent per hour (%/hr) (Mean)
	Baseline	Five Months
Continuous Testosterone	0.06	0.101
Monthly Cycled Testosterone	0.06	0.094
Placebo	0.05	0.066

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Changes in Serum Markers of Bone Turnover.

"Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include:~Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium" (NCT00957528)
Timeframe: 5 months

Intervention	nM BCE (Bone Collagen Equivalents) (Mean)
	NTX Baseline	NTX Five Months	TRAP5b Baseline	TRAP5b Five Months	Osteocalcin Baseline	Osteocalcin Five Months	BAP Baseline	BAP Five Months	iPTH Baseline	iPTH Five Months	Calcitonin Baseline	Calcitonin Five months
Continuous Testosterone	15	11	2	1	9	7	17	15	53	60	4	3
Monthly Cycled Testosterone	14	11	2	2	8	8	20	19	37	28	4	4
Placebo	12	13	2	2	8	8	22	21	40	45	3	3

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Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months

Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings). (NCT00957528)
Timeframe: 5 months

Intervention	pounds (Mean)
	Arm Curl Baseline	Arm Extension Baseline	Leg Curl Baseline	Leg Extension Baseline	Arm Curl Month 1	Arm Curl Month 2	Arm Curl Month 3	Arm Curl Month 4	Arm Curl Month 5	Arm Extension Month 1	Arm Extension Month 2	Arm Extension Month 3	Arm Extension Month 4	Arm Extension Month 5	Leg Curl Month 1	Leg Curl Month 2	Leg Curl Month 3	Leg Curl Month 4	Leg Curl Month 5	Leg Extension Month 1	Leg Extension Month 2	Leg Extension Month 3	Leg Extensuion Month 4	Leg Extension Month 5
Continuous Testosterone	32	38	40	66	34	39	37	41	38	37	44	44	44	45	41	48	48	50	51	67	78	76	82	83
Monthly Cycled Testosterone	39	41	44	73	41	40	43	43	45	41	42	43	44	45	46	47	43	50	50	73	77	80	79	85
Placebo	39	40	46	70	39	38	39	38	40	40	41	42	42	42	48	51	48	48	48	70	69	74	72	72

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Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)

Lean body mass is expressed in grams as calculated by Hologic DEXA. (NCT00957528)
Timeframe: 5 months

Intervention	grams (Mean)
	Lean Body Mass Baseline	Lean Body Mass Month 1	Lean Body Mass Month 2	Lean Body Mass Month 3	Lean Body Mass Month 4	Lean Body Month 5
Continuous Testosterone	57746	60469.3	62680.1	61167.3	61436.6	60871.4
Monthly Cycled Testosterone	57101	59155.4	56787.8	59186	59838.6	58846.9
Placebo	62344	62994.7	62038.7	62256.5	62755.4	61250.6

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Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)

Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months (NCT00957528)
Timeframe: 5 months

Intervention	gm/cm^2 (Mean)
	Total Baseline	Total Five Months	Lumbar Spine Baseline	Lumbar Spine Five Months	Pelvis baseline	Pelvis Five Months	Forearm Baseline	Forearm Five Months
Continuous Testosterone	1.12	1.14	1.16	1.19	1.27	1.28	0.61	0.62
Monthly Cycled Testosterone	1.07	1.05	1.00	1.00	1.15	1.14	0.59	0.59
Placebo	1.12	1.08	1.06	1.07	1.46	1.28	0.59	0.61

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Hematocrit Measured on Treatment Day 1 (Baseline Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 1

Intervention	percent (Mean)
Testosterone Injection	39.17
Testosterone Gel	38.4
Medrol 6 Day Dose Pack	40.45
Testosterone Injection and Medrol 6 Day Dose Pack	39.86

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Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - after exercise

Intervention	ug/dL (Mean)
Testosterone Injection	7.71
Testosterone Gel	7.20
Medrol 6 Day Dose Pack	4.76
Testosterone Injection and Medrol 6 Day Dose Pack	4.15

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Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol

Intervention	ug/dL (Mean)
Testosterone Injection	7.25
Testosterone Gel	6.00
Medrol 6 Day Dose Pack	6.64
Testosterone Injection and Medrol 6 Day Dose Pack	6.28

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Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol

Intervention	ug/dL (Mean)
Testosterone Injection	7.05
Testosterone Gel	6.28
Medrol 6 Day Dose Pack	4.40
Testosterone Injection and Medrol 6 Day Dose Pack	5.78

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Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol

Intervention	ug/dL (Mean)
Testosterone Injection	7.84
Testosterone Gel	5.97
Medrol 6 Day Dose Pack	6.28
Testosterone Injection and Medrol 6 Day Dose Pack	5.19

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 1

Intervention	ug/dL (Mean)
Testosterone Injection	46.34
Testosterone Gel	34.16
Medrol 6 Day Dose Pack	62.55
Testosterone Injection and Medrol 6 Day Dose Pack	46.07

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)

Intervention	ug/dL (Mean)
Testosterone Injection	37.96
Testosterone Gel	35.54
Medrol 6 Day Dose Pack	34.74
Testosterone Injection and Medrol 6 Day Dose Pack	36.07

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the treatment week average of study days 1-8." (NCT00957801)
Timeframe: Study days 1-7 (treatment week)

Intervention	units on a scale (Mean)
Testosterone Injection	1.84
Testosterone Gel	1.79
Medrol 6 Day Dose Pack	2.19
Testosterone Injection and Medrol 6 Day Dose Pack	1.57

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the pre-treatment week average of study days -7 to -1." (NCT00957801)
Timeframe: Study days -7 to -1 (Pre - treatment)

Intervention	units on a scale (Mean)
Testosterone Injection	2.25
Testosterone Gel	1.47
Medrol 6 Day Dose Pack	2.26
Testosterone Injection and Medrol 6 Day Dose Pack	1.86

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Triglycerides Measured on Treatment Day 1 (Baseline Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Intervention	mg/dL (Mean)
Testosterone Injection	140.42
Testosterone Gel	164.0
Medrol 6 Day Dose Pack	122.5
Testosterone Injection and Medrol 6 Day Dose Pack	119.71

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Hematocrit Measured on Treatment Day 8 (Post Study)

Intervention	percent (Mean)
Testosterone Injection	38.74
Testosterone Gel	37.23
Medrol 6 Day Dose Pack	40.53
Testosterone Injection and Medrol 6 Day Dose Pack	39.24

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High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Intervention	mg/dL (Mean)
Testosterone Injection	40.29
Testosterone Gel	38.86
Medrol 6 Day Dose Pack	46.50
Testosterone Injection and Medrol 6 Day Dose Pack	42.14

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High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	41.29
Testosterone Gel	36.71
Medrol 6 Day Dose Pack	47.67
Testosterone Injection and Medrol 6 Day Dose Pack	43.43

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 1

Intervention	nmol/L (Mean)
Testosterone Injection	21.78
Testosterone Gel	19.86
Medrol 6 Day Dose Pack	25.66
Testosterone Injection and Medrol 6 Day Dose Pack	24.70

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)

Intervention	nmol/L (Mean)
Testosterone Injection	17.62
Testosterone Gel	20.13
Medrol 6 Day Dose Pack	19.22
Testosterone Injection and Medrol 6 Day Dose Pack	14.57

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Intervention	ng/mL (Mean)
Testosterone Injection	80.16
Testosterone Gel	72.11
Medrol 6 Day Dose Pack	69.17
Testosterone Injection and Medrol 6 Day Dose Pack	54.86

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Insulin Measured on Treatment Day 1 (Baseline Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 1

Intervention	uIu/mL (Mean)
Testosterone Injection	8.53
Testosterone Gel	10.28
Medrol 6 Day Dose Pack	4.09
Testosterone Injection and Medrol 6 Day Dose Pack	9.89

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Insulin Measured on Treatment Day 8 (Post Study)

Intervention	uIu/mL (Mean)
Testosterone Injection	7.47
Testosterone Gel	10.58
Medrol 6 Day Dose Pack	3.92
Testosterone Injection and Medrol 6 Day Dose Pack	3.89

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Total Cholesterol Measured on Treatment Day 1 (Baseline Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Intervention	mg/dL (Mean)
Testosterone Injection	171.29
Testosterone Gel	165.57
Medrol 6 Day Dose Pack	168.00
Testosterone Injection and Medrol 6 Day Dose Pack	156.71

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Total Cholesterol Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	172
Testosterone Gel	162.86
Medrol 6 Day Dose Pack	166.17
Testosterone Injection and Medrol 6 Day Dose Pack	141.86

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C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Intervention	mg/dL (Mean)
Testosterone Injection	0.47
Testosterone Gel	0.31
Medrol 6 Day Dose Pack	0.32
Testosterone Injection and Medrol 6 Day Dose Pack	0.3

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Triglycerides Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	112.57
Testosterone Gel	160.0
Medrol 6 Day Dose Pack	155.17
Testosterone Injection and Medrol 6 Day Dose Pack	116.28

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Intervention	mg/dL (Mean)
Testosterone Injection	28
Testosterone Gel	33.14
Medrol 6 Day Dose Pack	24.67
Testosterone Injection and Medrol 6 Day Dose Pack	23.86

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	26.71
Testosterone Gel	29.29
Medrol 6 Day Dose Pack	31.0
Testosterone Injection and Medrol 6 Day Dose Pack	24.71

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C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)

Intervention	mg/dL (Mean)
Testosterone Injection	0.47
Testosterone Gel	0.33
Medrol 6 Day Dose Pack	0.32
Testosterone Injection and Medrol 6 Day Dose Pack	0.4

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Intervention	mg/dL (Mean)
Testosterone Injection	103.0
Testosterone Gel	93.57
Medrol 6 Day Dose Pack	96.83
Testosterone Injection and Medrol 6 Day Dose Pack	90.71

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Serum Total Testosterone Measured on Treatment Day 4

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 4

Intervention	ng/dL (Mean)
Testosterone Injection	779.57
Testosterone Gel	441.71
Medrol 6 Day Dose Pack	271.6
Testosterone Injection and Medrol 6 Day Dose Pack	734.57

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Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Intervention	ng/mL (Mean)
Testosterone Injection	1.92
Testosterone Gel	2.33
Medrol 6 Day Dose Pack	1.85
Testosterone Injection and Medrol 6 Day Dose Pack	1.83

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Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)

Intervention	ng/mL (Mean)
Testosterone Injection	1.98
Testosterone Gel	2.32
Medrol 6 Day Dose Pack	1.78
Testosterone Injection and Medrol 6 Day Dose Pack	2.07

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Serum Estradiol Measured on Treatment Day 1 (Baseline Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 1

Intervention	pg/mL (Mean)
Testosterone Injection	22.86
Testosterone Gel	33.69
Medrol 6 Day Dose Pack	36.33
Testosterone Injection and Medrol 6 Day Dose Pack	34.71

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Serum Estradiol Measured on Treatment Day 8 (Post Study)

Intervention	pg/mL (Mean)
Testosterone Injection	48.29
Testosterone Gel	33.43
Medrol 6 Day Dose Pack	30.83
Testosterone Injection and Medrol 6 Day Dose Pack	47.14

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Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)

Intervention	ng/dL (Mean)
Testosterone Injection	307.57
Testosterone Gel	363.43
Medrol 6 Day Dose Pack	408.17
Testosterone Injection and Medrol 6 Day Dose Pack	318.68

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Serum Total Testosterone Measured on Treatment Day 2

Intervention	ng/dL (Mean)
Testosterone Injection	980.86
Testosterone Gel	526.71
Medrol 6 Day Dose Pack	191.87
Testosterone Injection and Medrol 6 Day Dose Pack	675.86

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Serum Total Testosterone Measured on Treatment Day 3

"TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 3

Intervention	ng/dL (Mean)
Testosterone Injection	828.71
Testosterone Gel	527.43
Medrol 6 Day Dose Pack	206.0
Testosterone Injection and Medrol 6 Day Dose Pack	673.29

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)

Intervention	ng/mL (Mean)
Testosterone Injection	71.77
Testosterone Gel	69.2
Medrol 6 Day Dose Pack	61.42
Testosterone Injection and Medrol 6 Day Dose Pack	90.74

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Serum Total Testosterone Measured on Treatment Day 5

"TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 5

Intervention	ng/dL (Mean)
Testosterone Injection	722.0
Testosterone Gel	460.14
Medrol 6 Day Dose Pack	246.33
Testosterone Injection and Medrol 6 Day Dose Pack	669.71

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Serum Total Testosterone Measured on Treatment Day 6

Intervention	ng/dL (Mean)
Testosterone Injection	629.0
Testosterone Gel	536.43
Medrol 6 Day Dose Pack	284.5
Testosterone Injection and Medrol 6 Day Dose Pack	645.14

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Serum Total Testosterone Measured on Treatment Day 7

Intervention	ng/dL (Mean)
Testosterone Injection	578.29
Testosterone Gel	485.86
Medrol 6 Day Dose Pack	320.0
Testosterone Injection and Medrol 6 Day Dose Pack	579.57

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Serum Total Testosterone Measured on Treatment Day 8 (Post Study)

Intervention	ng/dL (Mean)
Testosterone Injection	454.29
Testosterone Gel	435.14
Medrol 6 Day Dose Pack	340.17
Testosterone Injection and Medrol 6 Day Dose Pack	481.14

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	104.0
Testosterone Gel	94.57
Medrol 6 Day Dose Pack	87.5
Testosterone Injection and Medrol 6 Day Dose Pack	75.14

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Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)

The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement. (NCT00965341)
Timeframe: Day 29 (+/- 3 days)

Intervention	units on a scale (Mean)
	FACIT-F Total Score (29 days-baseline)	FACIT-F Fatigue Subscale (29 days-baseline)
Placebo	13	14
Testosterone	12	12

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The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).

The ESAS assessed 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0-10 (0 = no symptom, 10 = worst possible severity). Depression was assessed using the 14-item HADS questionnaire. Each item on the questionnaire was scored from 0-3. Total Scores for the HADS Questionnaire range from 0 to 42 with higher scores denoting feeling of depression. (NCT00965341)
Timeframe: Day 29 (+/- 3 days)

Intervention	units on a scale (Mean)
	Anxiety, ESAS	Depression, HADS	Well being, ESAS	Sleep, ESAS	Appetite, ESAS	Dyspnea, ESAS	Drowsiness, ESAS	Nausea, ESAS	Fatigue, ESAS	Pain, ESAS
Placebo	5	6	3	4	4	3	4	2	6	3
Testosterone	7	7	5	5	5	2	5	2	6	3

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Percentage of Subjects With Cavg Within the Reference Range

The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone. (NCT00975650)
Timeframe: Each period is 7 days

,,,

Intervention	Participants (Count of Participants)
	Testosterone	Dihydrotestosterone
Treatment A	19	24
Treatment B	27	31
Treatment C	27	34
Treatment D	42	22

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Serum Testosterone Ln-Cmax

The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®. (NCT00975650)
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Intervention	ng/dL (Mean)
Treatment A	6.25
Treatment B	6.41
Treatment C	6.54
Treatment D	6.36

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Serum Testosterone Ln-AUCt

(NCT00975650)
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Intervention	ng.h/dL (Mean)
Treatment A	8.80
Treatment B	8.90
Treatment C	8.95
Treatment D	9.09

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Serum Testosterone Cavg

(NCT00975650)
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Intervention	ng/dL (Mean)
Treatment A	287.10
Treatment B	316.64
Treatment C	336.11
Treatment D	384.62

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Serum Dihydrotestosterone Ln-Cmax

(NCT00975650)
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Intervention	ng/dL (Mean)
Treatment A	3.54
Treatment B	3.67
Treatment C	3.80
Treatment D	3.44

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Serum Dihydrotestosterone Ln-AUCt

(NCT00975650)
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Intervention	ng.h/dL (Mean)
Treatment A	6.34
Treatment B	6.47
Treatment C	6.52
Treatment D	6.33

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Serum Dihydrotestosterone Cavg

(NCT00975650)
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

Intervention	ng/dL (Mean)
Treatment A	25.24
Treatment B	28.97
Treatment C	30.79
Treatment D	24.69

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Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01084759)
Timeframe: 2 years

Intervention	participants (Number)
Treatment Group	7

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Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.

(NCT01084759)
Timeframe: 3 months

Intervention	Percentage of Participants (Number)
Treatment Group	42.9

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Time to PSA Progression

Time to a PSA increase above the PSA level obtained after 3 months on testosterone treatment over two successive measurements 2 weeks apart. (NCT01084759)
Timeframe: 2 years

Intervention	days (Median)
Treatment Group	221

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Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours

A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing. (NCT01104246)
Timeframe: Day 28/29

Intervention	ng/dL (Mean)
Testosterone Transdermal Systems	463

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Change From Baseline in Weight

Weight in kilograms (NCT01121211)
Timeframe: Baseline, 24 Weeks

Intervention	kilograms (Mean)
Testosterone	0.1
Placebo	1.5

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Change From Baseline in Depression Symptom Severity

Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23) (NCT01121211)
Timeframe: Baseline, 24 weeks

Intervention	HAM-D score on a scale (Mean)
Testosterone	-3
Placebo	-3

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Insulin Sensitivity

measured by HE clamps (baseline and 6 mths) (NCT01127659)
Timeframe: baseline to 6 months

Intervention	mg/kg fat free mass/min (Mean)
	baseline
Eugonadal Diabetes	10.29
Eugonadal Obese	12.30

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Insulin Sensitivity

measured by HE clamps (baseline and 6 mths) (NCT01127659)
Timeframe: baseline to 6 months

,,,

Intervention	mg/kg fat free mass/min (Mean)
	baseline	6 months
Diabetes With HH: Placebo	5.12	5.06
Diabetes With HH: Testosterone	6.66	8.73
Obese With HH: Placebo	12.93	14.57
Obese With HH: Testosterone	11.37	12.96

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Body Composition

Body composition using Total body fat mass (kg) (NCT01127659)
Timeframe: baseline to 6 months

,,,

Intervention	kg (Mean)
	Baseline	24 WEEKS
Diabetes With HH: Placebo	44.5	45.4
Diabetes With HH: Testosterone	44.5	42.1
Obese Placebo	48.8	48.4
Obese Testosterone	50.2	46.4

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Body Composition

Body composition using Total body fat mass (kg) (NCT01127659)
Timeframe: baseline to 6 months

Intervention	kg (Mean)
	Baseline
Eugonadal Diabetes	34.0
Eugonadal Obese	40.2

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Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score

The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=[(MFI value at Month 6-MFI value at baseline)/MFI baseline value] X 100. (NCT01143818)
Timeframe: Baseline to Month 6

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	-21.5

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Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score

The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = [(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value]x 100. (NCT01143818)
Timeframe: Baseline to Month 6

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	115.7

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Percent Change From Baseline to Month 6 in Body Mass Index (BMI)

The BMI was measured in kg/m^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/[(height (m) x height (m)] and was measured to 1 decimal point precision. (NCT01143818)
Timeframe: Baseline to Month 6

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	-2.38

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Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score

The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100. (NCT01143818)
Timeframe: Baseline to Month 6

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	-29.0

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Maximum Estradiol Concentration

(NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
300 mg Oral Testosterone	14	9

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Maximum Testosterone Concentration

initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment (NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
Acyline and 300 mg Oral Testosterone	924	741

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Free Testosterone Mean Concentration

Free T normal range 4.7-18 ng/dL (NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1-2	Day 9-10
300 mg Oral Testosterone	8.7	8.3

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Mean Dihydrotestosterone (DHT) Concentration

(NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
Acyline and 300 mg Oral Testosterone	96	69

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Mean Testosterone Concentration

initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment (NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
Acyine and 300 mg Oral Testosterone	378	315

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Mean Estradiol Concentration

(NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
300 mg Oral Testosterone	11	7

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Mean SHGB Concentration

(NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
300 mg Oral Testosterone	27	19

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Free T Maximum Concentration

Free T normal range 4.7-18 ng/dL (NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1-2	Day 9-10
300 mg Oral Testosterone	24	21

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Maximum Sex Hormone-Binding Globulin (SHGB)Concentration

(NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
300 mg Oral Testosterone	31	22

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Maximum Dihydrotestosterone (DHT) Concentration

(NCT01167829)
Timeframe: baseline & day 9

Intervention	ng/dL (Geometric Mean)
	Day 1	Day 9
300 mg Oral Testosterone	233	142

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Restricted Functional Independence Measure (FIM)

The FIM is the most widely accepted functional assessment measure in use in the rehabilitation community in the US. It is an 18-item ordinal clinician rating scale that is useful for assessment of functional skills progress during inpatient rehabilitation. It measures levels of independent/dependent performance of 13 motor functions and 5 cognitive functions. By adding the points for each item, the possible total score ranges from 18 to 126, with higher numbers indicating better performance. A restricted FIM total score that eliminated the toileting, bladder management and bowel management items was computed and used in the final analysis with scores ranging from 14-105). The restricted FIM total score was used as the primary outcome measure. (NCT01201863)
Timeframe: Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.

Intervention	units on a scale (Median)
	Baseline	Six Week
Intervention - Treatment	34	52
Intervention Placebo	16	31
No Intervention	21	36

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Insulin Resistance - HOMA-IR

Blood samples were taken for fasting glucose and insulin levels. From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5. (NCT01208038)
Timeframe: 12 weeks from baseline

Intervention	units on a scale (Mean)
Testosterone	0.106

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Endothelial Function

Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischemia, compared to the control arm. Official reference values do not exist however a lower RHI (<2.0) is usually considered indicative of endothelial dysfunction. (NCT01208038)
Timeframe: 12 weeks from baseline

Intervention	units on a scale (Mean)
Testosterone	0.06

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Arterial Compliance - Augmentation Index

Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (AtCor Medical Ltd., Sydney, Australia; software version 8.0). The central (ascending aortic) pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function. The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can then be calculated by analysis of the central waveform. Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the central pulse pressure. (NCT01208038)
Timeframe: 12 weeks from baseline

Intervention	percentage of Arterial stiffness (Mean)
Testosterone	1.067

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Libido - B-PFSF Score

Libido was assessed at each visit using the Brief profile of female sexual function (BPFSF), a validated self-administered questionnaire for identifying Hypoactive Sexual Desire Disorder (HSDD). The BPFSF is based on 7 questions. Each question is scored on a 6-point scale from 'always' to 'never'. A total score is total score ranging from 0 to 35. Previous studies have identified a score of less than 20 as suggestive of HSDD. (NCT01208038)
Timeframe: 12 weeks from baseline

Intervention	units on a scale (Mean)
Testosterone	5.05

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Intratesticular Androstenedione (ADD) Level

(NCT01215292)
Timeframe: 10 days

Intervention	ng/mL (Median)
Acyline + Testosterone Gel (Tgel)+ Placebo	.87
Acyline + Tgel + Ketoconazole 400mg	0.5
Acyline + Tgel + Ketoconazole 800mg	0.12
Acyline & TGel & Dutasteride 2.5mg	1.7
Acyline & TGel & Anastrazole 1mg	3.6

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Intratesticular Dihydrotestosterone (DHT) Level

(NCT01215292)
Timeframe: 10 days

Intervention	ng/mL (Median)
Acyline + Testosterone Gel (Tgel)+ Placebo	3.17
Acyline & TGel & Ketoconazole 400 mg	2.08
Acyline & TGel & Ketoconazole 800 mg	1.46
Acyline & TGel & Dutasteride	0.12
Acyline & TGel & Anastrazole	3.63

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Intratesticular Testosterone (IT-T) Level

(NCT01215292)
Timeframe: 10 days

Intervention	ng/mL (Median)
Acyline + Testosterone Gel + Placebo	14
Acyline + Tgel + Ketoconazole 400mg	3.7
Acyline + Tgel + Ketoconazole 800mg	1.7
Acyline & TGel & Dutasteride 2.5mg	18.4
Acyline & TGel & Anastrazole 1mg	24.0

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Time to Target Eugonadal Range

The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data. (NCT01228071)
Timeframe: 24 hours

Intervention	hours (Median)
40 mg Daily Dose of Testosterone Gel 2%	2.85

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Time to Steady State (SS)

Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS. (NCT01228071)
Timeframe: 14 days

Intervention	days (Median)
40 mg Daily Dose of Testosterone Gel 2%	1.13

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Gel Drying Time

"Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3× 5 postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF." (NCT01228071)
Timeframe: 1 day; drying time measured following gel application on Day 14

Intervention	minutes (Median)
40 mg Daily Dose of Testosterone Gel 2%	2.4

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Cavg of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Intervention	ng/dL (Mean)
10.0 mg of TBS-1, 4.0% T.I.D.	413
13.5 mg of TBS-1, 4.5% B.I.D	408
11.25 mg of TBS-1, 4.5% T.I.D	396

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AUC0-t of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Intervention	ng.h/dL (Mean)
10.0 mg Testosterone t.i.d.	9920.07
13.5 mg Testosterone b.i.d.	9781.39
11.25 mg Testosterone t.i.d.	9505.03

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Cmax of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Intervention	ng/dL (Mean)
10.0 mg Testosterone t.i.d.	830
13.5 mg Testosterone b.i.d.	1050
11.25 mg Testosterone t.i.d.	883

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Change in FSH After 3 Months of Treatment

(NCT01270841)
Timeframe: 3 months

Intervention	mIU/mL (Mean)
Placebo	-0.2
Testim (Topical Testosterone)	-4.4
Androxal 12.5 mg	5.1
Androxal 25 mg	7.4

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Change in Luteinizing Hormone Levels

Changes in values from baseline in LH at month 3 (NCT01270841)
Timeframe: 3 months

Intervention	mIU/mL (Mean)
Placebo	-0.1
Testim (Topical Testosterone)	-2.4
Androxal 12.5 mg	4.8
Androxal 25 mg	6.9

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Change in Total Morning Testosterone

Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim (NCT01270841)
Timeframe: 3 months

Intervention	ng/dL (Mean)
Placebo	-16.9
Testim (Topical Testosterone)	253.7
Androxal 12.5 mg	258.5
Androxal 25 mg	197.3

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Reproductive Safety

Change from baseline in sperm concentration (NCT01270841)
Timeframe: 3 months

Intervention	millions/mL (Mean)
Placebo	-19.1
Testim (Topical Testosterone)	-29.5
Androxal 12.5 mg	8.2
Androxal 25 mg	-2.8

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Change of Maximal Voluntary Strength

Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities. (NCT01275365)
Timeframe: 6 months from baseline

,,,

Intervention	newton (Mean)
	Maximal voluntary strength in leg press	Maximal voluntary strength in chest press
Placebo/High Protein	156.0	16.6
Placebo/Low Protein	134.6	41.5
Testosterone/High Protein	191.4	59.3
Testosterone/Low Protein	201.8	64.5

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Change of Derogatis Affective Balance Scale (DABS)

The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity. (NCT01275365)
Timeframe: 6 months from baseline

,,,

Intervention	units on a scale (Mean)
	Affects Expressiveness Index (AEI)	Positive Total score (PTOT)	Negative Total score (NTOT)
Placebo/High Protein	1.45	2.10	-0.65
Placebo/Low Protein	0.65	1.38	-1.50
Testosterone/High Protein	-3.17	1.89	-5.53
Testosterone/Low Protein	-0.50	0.69	-0.88

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Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)

36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance. (NCT01275365)
Timeframe: 6 months from baseline

Intervention	units on a scale (Mean)
Placebo/Low Protein	-1.4
Placebo/High Protein	-5.5
Testosterone/Low Protein	2.1
Testosterone/High Protein	-2.9

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Change of 6-minute Walking Distance

Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance (NCT01275365)
Timeframe: 6 months from baseline

Intervention	meters (Mean)
Placebo/Low Protein	44.2
Placebo/High Protein	49.9
Testosterone/Low Protein	38.2
Testosterone/High Protein	25.5

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Change of 50-meter Loaded Walking Test

Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. The test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags. Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time. (NCT01275365)
Timeframe: 6 months from baseline

Intervention	meters per second (Mean)
Placebo/Low Protein	0.15
Placebo/High Protein	0.11
Testosterone/Low Protein	0.06
Testosterone/High Protein	0.08

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Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)

Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA) (NCT01275365)
Timeframe: 6 months from baseline

Intervention	kg (Mean)
Placebo/Low Protein	0.14
Placebo/High Protein	0.74
Testosterone/Low Protein	4.43
Testosterone/High Protein	4.13

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Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life. (NCT01275365)
Timeframe: 6 months from baseline

Intervention	units on a scale (Mean)
Placebo/Low Protein	0.14
Placebo/High Protein	-0.14
Testosterone/Low Protein	-0.53
Testosterone/High Protein	1.05

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Change of Psychological Well Being Index (PGWBI)

The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance. (NCT01275365)
Timeframe: 6 months from baseline

Intervention	units on a scale (Mean)
Placebo/Low Protein	-0.56
Placebo/High Protein	1.17
Testosterone/Low Protein	0.32
Testosterone/High Protein	2.68

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Change of Stair Climbing Tests

Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. (NCT01275365)
Timeframe: 6 months from baseline

,,,

Intervention	watts (Mean)
	Unloaded	Loaded
Placebo/High Protein	55.4	83.7
Placebo/Low Protein	50.8	56.8
Testosterone/High Protein	4.2	26.9
Testosterone/Low Protein	53.2	56.6

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Change of Leg Press Power

Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig. (NCT01275365)
Timeframe: 6 months from baseline

Intervention	watts (Mean)
Placebo/Low Protein	26.9
Placebo/High Protein	96.9
Testosterone/Low Protein	61.5
Testosterone/High Protein	81.7

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Percent of Subjects With Testosterone Levels in the Normal Range.

Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (>= 300 ng/dL to <= 1030 ng/dL), at least 85% of subjects with Cmax <= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax >= 2500 ng/dL. (NCT01323140)
Timeframe: Day 29/30

Intervention	percentage of participants (Number)
Treatment	68.4

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Prostate Specific Antigen

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/dL (Median)
Arm 1	0.82
Arm 2	0.48
Arm 3	0.61
Arm 4	0.58
Arm 5	0.52
Arm 6	0.76

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Prostate Volume

(NCT01327495)
Timeframe: 12 weeks

Intervention	cm^3 (Median)
Arm 1	19
Arm 2	18
Arm 3	19
Arm 4	15
Arm 5	16
Arm 6	20

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Serum Testosterone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/mL (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	4.6
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	1.9
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	3.4
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	3.5
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	6.1
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	7.7

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Progesterone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.09
Arm 2	0.08
Arm 3	0.06
Arm 4	0.08
Arm 5	0.09
Arm 6	0.07

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Pregnenolone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	28.7
Arm 2	29.5
Arm 3	32.7
Arm 4	32.4
Arm 5	27.9
Arm 6	23.9

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International Prostate Symptom Score (IPSS)

IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic (NCT01327495)
Timeframe: 12 weeks

Intervention	units on a scale (Median)
Arm 1	1
Arm 2	2
Arm 3	2.5
Arm 4	0
Arm 5	2.5
Arm 6	4

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Androsterone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.17
Arm 2	0.15
Arm 3	0.12
Arm 4	0.17
Arm 5	0.17
Arm 6	0.21

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DHEA

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	29.3
Arm 2	26.2
Arm 3	22.1
Arm 4	26.8
Arm 5	24.4
Arm 6	18.6

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Dihydrotestosterone (DHT)

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/mL (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	0.3
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	0.6
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	0.9
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	1.0
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	1.5
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	1.8

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Androstenedione

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.16
Arm 2	0.11
Arm 3	0.12
Arm 4	0.13
Arm 5	0.18
Arm 6	0.14

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17-OHPreg

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	1.19
Arm 2	1.25
Arm 3	1.23
Arm 4	1.05
Arm 5	1.02
Arm 6	1.36

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Prostate Tissue DHT Concentrations After Treatment

To measure intraprostatic dihydrotestosterone [DHT] levels (NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	4.05
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	4.26
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	2.99
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	3.88
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	4.12
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	5.11

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17-OHP

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.05
Arm 2	0.05
Arm 3	0.05
Arm 4	0.05
Arm 5	0.05
Arm 6	0.05

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Prostate Tissue Testosterone Concentrations After Treatment

To measure intraprostatic testosterone levels (NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	0.3
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	0.13
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	0.125
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	0.18
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	0.195
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	0.3

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Bioavailability (AUC0-t) of Total Testosterone Through Pharmacokinetic (PK) Profiles

Area under the concentration time curve from time zero to the last measurable concentration time point (AUC0-t) for single dose and AUCtau shown for multiple dose. (NCT01364623)
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing

Intervention	ng*h/dL (Geometric Mean)
Low Dose TBS-2 Single Dose	223.981
Medium Dose TBS-2 Single Dose	328.002
High Dose TBS-2 Single Dose	834.391
Medium Dose TBS-2 Multiple-Dose	553.325

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Area Under the Plasma Concentration Versus Time Curve (AUC) for Dihydrotestosterone Following TBS-2

AUCt shown for single dose and AUCtau for multiple dose. (NCT01364623)
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing

Intervention	ng*h/dL (Geometric Mean)
Low Dose TBS-2 - Single Dose	23.515
Medium Dose TBS-2 - Single Dose	38.457
High Dose TBS-2 - Single Dose	85.180
Medium Dose TBS-2 - Multiple Dose	122.194

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Bioavailability (Cmax) of Total Testosterone Through Pharmacokinetic Profiles

Cmax - maximum concentration of total testosterone observed after dosing of TBS-2 (NCT01364623)
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing

Intervention	ng/dL (Geometric Mean)
Low Dose TBS-2 - Single Dose	34.058
Medium Dose TBS-2 - Single Dose	62.880
High Dose TBS-2 - Single Dose	113.912
Medium Dose TBS-2 - Multiple Dose	137.555

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Area Under the Plasma Concentration Versus Time Curve (AUC) for Estradiol Following TBS-2

AUCt shown for single dose and AUCtau for multiple dose. (NCT01364623)
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing

Intervention	pg*h/mL (Geometric Mean)
Low Dose TBS-2 - Single Dose	105.763
Medium Dose TBS-2 - Single Dose	75.97
High Dose TBS-2 - Single Dose	43.97
Medium Dose TBS-2 - Multiple Dose	400.264

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Medium Dose TBS-2 Multiple Dose Average Steady-state Concentration (Cavg) of Total Testosterone

(NCT01364623)
Timeframe: -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48h after Day 3 dosing

Intervention	ng/dL (Mean)
Medium Dose TBS-2 - Multiple Dose	0.944

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Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome. (NCT01370369)
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

Intervention	hour (Median)
Testosterone 1.25	6.0
Testosterone 2.50	4.0
Testosterone 3.75	6.0

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Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	ng/dL (Mean)
Testosterone 1.25	64.4
Testosterone 2.50	93.3
Testosterone 3.75	120

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Frequency of Adverse Events (AEs)

The data were presented using descriptive statistics for this outcome. (NCT01370369)
Timeframe: From Baseline to Day 43

Intervention	number of event (Number)
Testosterone 1.25	1
Testosterone 2.50	2
Testosterone 3.75	2

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Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	hour (Median)
Testosterone 1.25	6.0
Testosterone 2.50	7.0
Testosterone 3.75	6.0

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Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	ng/dL (Mean)
Testosterone 1.25	586
Testosterone 2.50	907
Testosterone 3.75	1258

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Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	pg/mL (Mean)
Testosterone 1.25	134
Testosterone 2.50	229
Testosterone 3.75	382

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Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	hour (Median)
Testosterone 1.25	6.0
Testosterone 2.50	4.0
Testosterone 3.75	6.0

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Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome. (NCT01370369)
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13

Intervention	ng*hour/dL (Mean)
Single Testosterone Dose (Inner Thigh)	9472
Single Testosterone Dose (Abdomen)	8918
Single Testosterone Dose (Shoulder/Upper Arm)	13368

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Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	ng*hour/dL (Mean)
Testosterone 1.25	1063
Testosterone 2.50	1458
Testosterone 3.75	1974

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Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	pg*hour/mL (Mean)
Testosterone 1.25	1765
Testosterone 2.50	2655
Testosterone 3.75	4663

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Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

Intervention	ng*hour/dL (Mean)
Testosterone 1.25	9229
Testosterone 2.50	12148
Testosterone 3.75	17625

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Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome. (NCT01370369)
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13

Intervention	ng/dL (Mean)
Single Testosterone Dose (Inner Thigh)	519
Single Testosterone Dose (Abdomen)	451
Single Testosterone Dose (Shoulder/Upper Arm)	926

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Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome. (NCT01370369)
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13

Intervention	hour (Median)
Single Testosterone Dose (Inner Thigh)	24.0
Single Testosterone Dose (Abdomen)	9.0
Single Testosterone Dose (Shoulder/Upper Arm)	11.0

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Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.

Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome. (NCT01370369)
Timeframe: From Baseline to Day 43

Intervention	percentage of subjects (Number)
	Cave	Cmin
Testosterone 1.25	73.7	20.0
Testosterone 2.50	77.7	40.0
Testosterone 3.75	75.0	55.0

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Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene

Percent change in bone mineral density from baseline to 18 months. (NCT01378299)
Timeframe: baseline to 18 months

Intervention	PERCENT CHANGE (Mean)
	LUMBAR SPINE	FEMORAL NECK	TOTAL HIP
CC Genotype for the rs1062033	3.74	0.22	0.64
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	2.85	0.64	0.70
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene	4.72	-1.04	0.33

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Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene

Percent change in bone turnover from baseline to 18 months. (NCT01378299)
Timeframe: Baseline to 18 months

Intervention	perecent change (Mean)
	C-teloepetide	Osteocalcin
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	-9.75	-7.27
GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	3.35	-31.22
GG Genotype for RS 700518 of the CYP19A1 Gene	41.47	12.40

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Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene

Percent change in bone turnover markers (NCT01378299)
Timeframe: Baseline to 18 months

Intervention	Percent change (Mean)
	C-telopeptide	Osteocalcin
GC Genotype for the rs1062033 Polymorphism of the	5.89	-20.59
GG Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene	-14.49	-26.96
GG Genotype for the rs1062033 Polymorphism of the CYP19A1 Gene	48.96	33.59

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Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene

Percent change in bone mineral density from baseline to 18 months (NCT01378299)
Timeframe: form baseline to 18 months

Intervention	percent change (Mean)
	Lumbar spine	Total hip	Femoral neck
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	3.82	0.08	-1.25
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene	4.13	0.93	1.51
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene	3.69	0.38	-1.09

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Percent Change in Bone Mineral Density According to Body Mass Index (BMI)

Percent changes in bone mineral density from baseline (NCT01378299)
Timeframe: baseline to 18 months

Intervention	Percent change (Mean)
	lumbar spine	Total hip	femoral neck
BMI Group 1	3.00	0.14	0.71
BMI Group 2	4.90	1.74	-0.33
BMI Group 3	3.90	-0.27	0.16

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Percent Change in Aromatase Gene Activity From the Buffy Coat According to the 700518 Polymorphism of the CYP19A1 Gene

Percent change in gene expression from baseline to 18 months (NCT01378299)
Timeframe: Baseline to 6 months

Intervention	percent change (Mean)
GG Genotype for the rs700518 Polymorphism in the cYP19A1 Gene	25.0
GA Genoypr for the rs700518 Polymorphism of the CYP19A1 Gene	65.25
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	113.33

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Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus

Percent change in bone turnover markers from baseline to 18 months. (NCT01378299)
Timeframe: Baseline to 18 months

Intervention	Percentage Changes (Mean)
	C-telopeptide	Osteocalcin
Subjects With Diabetes Mellitus	73.55	20.54
Subjects Without Diabetes Mellitus	2.05	-6.62

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Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene

Percent change in PSA from baseline to 18 months (NCT01378299)
Timeframe: From baseline to 18 months

Intervention	percent change (Mean)
GG Genotype for the rs700518 Polymor[Hism of the CYP19A1 Gene	105.78
GA Genotype of the rs700518 Polymorphism in CYP19A1 Gen	58.52
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	44.44

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Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene

Percent change in PSA from baseline at 18 months (NCT01378299)
Timeframe: from baseline to 18 months

Intervention	precent change (Mean)
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene	85.15
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	62.86
CC Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene	52.93

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Percent Change in Hematocrit According to the Genotype of the 700518 Polymorphism of the CYP19A1gene

Percent change in hematocrit from baseline to 18 months (NCT01378299)
Timeframe: baseline to 18 months

Intervention	Percent change (Mean)
GG Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	11.32
GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	9.71
AA Genotype for the rs700518 Polymorphism of the	9.41

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Percent Change in Hematocrit According to re1062033 Polymorphism of the CYP19A1 Gene

Percent change in hematocrit from baseline to 18 months (NCT01378299)
Timeframe: Baseline to 18 months

Intervention	percent change (Mean)
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene	11.56
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	9.67
CC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	9.46

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Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus

Percent change in bone mineral density from baseline to 18 months (NCT01378299)
Timeframe: Baseline to 18 months

Intervention	Percent change (Mean)
	LUMBAR SPINE	TOTAL HIP	FEMORAL NECK
Subjects With Diabetes Mellitus	4.05	1.81	1.63
Subjects Without Diabetes Mellitus	3.28	0.53	-0.55

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Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.

The Cmax for plasma concentration. (NCT01386606)
Timeframe: Week 6

Intervention	ng/mL (Mean)
Androxal 6.25 mg	1.8154
Androxal 12.5 mg	3.3899
Androxal 25 mg	16.2993

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Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.

The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24). (NCT01386606)
Timeframe: Week 6

Intervention	ng*h/mL (Mean)
Androxal 6.25 mg	21.200
Androxal 12.5 mg	34.012
Androxal 25 mg	150.51

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24 Hour Average and Maximum Testosterone Concentration

"The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.~Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24." (NCT01386606)
Timeframe: Baseline and Week 6

,,,

Intervention	ng/dL (Mean)
	TTavg at Baseline	TTavg at Week 6	TTmax at Baseline	TTmax at Week 6
AndroGel	322.4	543.9	562.3	930.1
Androxal 12.5 mg	373.6	460.8	513.7	607.5
Androxal 25 mg	298.3	586.7	425.9	764.3
Androxal 6.25 mg	262.3	392.4	358.5	524.5

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Change in Follicle Stimulating Hormone (FSH)

Changes in morning FSH after continuous dosing (NCT01386606)
Timeframe: Baseline, Week 2, Week 4, Week 6

,,,

Intervention	mIU/mL (Mean)
	Morning FSH at Baseline	Morning FSH at Week 2	Morning FSH Change from Baseline at Week 2	Morning FSH at Week 4	Morning FSH Change from Baseline at Week 4	Morning FSH at Week 6	Morning FSH Change from Baseline at Week 6
AndroGel	6.38	3.80	-2.58	3.72	-2.66	3.35	-3.03
Androxal 12.5 mg	5.63	7.77	2.14	7.12	1.48	8.19	2.56
Androxal 25 mg	6.31	11.41	5.09	12.34	6.03	13.45	7.14
Androxal 6.25 mg	4.61	6.18	1.60	6.45	1.66	5.69	1.42

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Morning Testosterone Correlated With Serial Testosterone.

"9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.~If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation." (NCT01386606)
Timeframe: Week 6

Intervention	Number of Subjects (Number)
Androxal Pooled Dose Levels	35

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Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.

The Tmax for plasma concentration. (NCT01386606)
Timeframe: Week 6

Intervention	h (Mean)
Androxal 6.25 mg	2.33
Androxal 12.5 mg	2.42
Androxal 25 mg	2.41

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Change in Leuteinizing Hormone (LH)

Changes in morning LH after continuous dosing (NCT01386606)
Timeframe: Baseline, Week 2, Week 4, Week 6

,,,

Intervention	mIU/mL (Mean)
	Morning LH at Baseline	Morning LH at Week 2	Morning LH Change from Baseline at Week 2	Morning LH at Week 4	Morning LH Change from Baseline at Week 4	Morning LH at Week 6	Morning LH Change from Baseline at Week 6
AndroGel	3.57	2.00	-1.57	1.88	-1.69	2.2	-1.41
Androxal 12.5 mg	4.82	8.60	3.78	7.20	2.38	8.2	3.39
Androxal 25 mg	4.98	9.64	4.66	11.78	6.79	14.5	9.51
Androxal 6.25 mg	3.63	5.49	1.99	6.92	3.43	6.1	2.60

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Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL

The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL (NCT01403116)
Timeframe: Following 90 days of treatment

Intervention	percentage of partipants (Geometric Mean)
Oral Testosterone Undecanoate (TU)	83.6
Topical Testosterone Gel	79.2

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% of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90

Percentage of Oral TU treated patients who reached study day 90 and had a maximum serum T concentrations (Cmax) values greater than 1500 ng/dL(objective to meet <15%). (NCT01403116)
Timeframe: 90 days

Intervention	Participants (Count of Participants)
Oral Testosterone Undecanoate (TU)	61

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Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks

"The MSHQ-EjD-SF was a 4 item, self-reported questionnaire used for the assessment of EjD during the past month. The MSHQ-EjD-SF Bother/Satisfaction Score was based on Q4: If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this? Scores ranged from 0 (no problem with ejaculation), 1 (not at all bothered) to 5 (extremely bothered). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Bother/Satisfaction Score as fixed effects, and unstructured covariance structure for modeling correlation." (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	units on a scale (Least Squares Mean)
Testosterone Solution 2%	-1.65
Placebo	-1.62

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Change From Baseline in Ejaculate Volume at 16 Weeks

The change from baseline in ejaculate volume was determined by actual measurement of semen volume in milliliters (mL). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation. (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	mL (Least Squares Mean)
Testosterone Solution 2%	-0.12
Placebo	0.32

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Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks

The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived volume of ejaculate rated from 0 (no ejaculate) to 10 (high volume of ejaculate). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation. (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	units on a scale (Least Squares Mean)
Testosterone Solution 2%	1.85
Placebo	1.43

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Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks

IIEF: 15 item, self-reported questionnaire assessing overall erectile function and satisfaction during past month. Orgasmic Function Domain Score: sum of IIEF scores for Q9 and Q10. In Q9, participants (pts) identified how often they ejaculated when having sexual stimulation or intercourse. In Q10, pts identified how often they had a feeling of an orgasm with or without ejaculation when having sexual stimulation or intercourse. For each Q, scores ranged from 0 (no sexual stimulation or intercourse), 1 (almost never or never) to 5 (almost always or always). Total Orgasmic Function Domain Scores ranged from 0 to 10. LS mean of change from baseline calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Orgasmic Function Domain Score as fixed effects, and unstructured covariance structure for modeling correlation. (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	units on a scale (Least Squares Mean)
Testosterone Solution 2%	1.21
Placebo	1.29

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Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks

MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed-effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level [≥200 nanograms per deciliter (ng/dL) versus (vs.) <200 ng/dL], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation. (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	units on a scale (Least Squares Mean)
Testosterone Solution 2%	3.61
Placebo	2.95

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Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks

The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the change from baseline number of sexual attempts at 16 weeks. LS mean of change from baseline was calculated using an analysis of covariance (ANCOVA) including treatment group, region, baseline total testosterone level, baseline ED severity (normal, mild, moderate, severe) as fixed effects, and centered baseline as a covariate. (NCT01419236)
Timeframe: Baseline, up to 16 weeks

Intervention	sexual attempts (Least Squares Mean)
Testosterone Solution 2%	0.89
Placebo	-0.14

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Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks

The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived force of ejaculation rated from 0 (could not ejaculate) to 10 (strong ejaculation). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline perceived force of ejaculation as fixed effects, and unstructured covariance structure for modeling correlation. (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	units on a scale (Least Squares Mean)
Testosterone Solution 2%	2.28
Placebo	1.47

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Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks

The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Reported is orgasmic pleasure rated from 0 (no pleasure) to 10 (excellent). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline orgasmic pleasure as fixed effects, and unstructured covariance structure for modeling correlation. (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	units on a scale (Least Squares Mean)
Testosterone Solution 2%	1.37
Placebo	1.05

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Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks

The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is delayed ejaculation rated from 0 (did not ejaculate) to 10 (optimal/best ejaculate time). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline delayed ejaculation as fixed effects, and unstructured covariance structure for modeling correlation. (NCT01419236)
Timeframe: Baseline, 16 weeks

Intervention	units on a scale (Least Squares Mean)
Testosterone Solution 2%	1.68
Placebo	1.38

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Serum Testosterone Cavg

The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL) (NCT01446042)
Timeframe: 90 days

Intervention	Participants (Count of Participants)
TBS-1 - b.i.d.	76
TBS-1 - b.i.d./t.i.d.	43
TBS-1 - t.i.d.	61

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Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90

"To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90:~A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed~A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed~No analyzed participants with a Cmax (maximum testosterone concentration) >2500 ng/dL" (NCT01446042)
Timeframe: 90 days

Intervention	Participants (Count of Participants)
	Cmax <=1500 ng/dL	1800 ng/dL <= Cmax <=2500 ng/dL	Cmax >2500 ng/dL
TBS-1 - b.i.d.	107	6	1
TBS-1 - b.i.d./t.i.d.	77	2	0
TBS-1 - t.i.d.	58	1	0

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Percent Change in Spine Bone Density From Baseline to 12 Months

Percent Change in Spine Bone Density from Baseline (month 0) to Month 12 (NCT01460654)
Timeframe: Baseline and 12 months

Intervention	percent change of bone mineral density (Mean)
Testosterone and Placebo Alendronate	2.52
Alendronate and Placebo Testosterone	0.61
Testosterone and Alendronate	3.16

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Pharmacokinetics of Total Testosterone and DHT Measuring Cmin

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Intervention	ng/dL (Mean)
	Testosterone	DHT
Testosterone 2.50 mL (Hand)	234	35.4

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Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

Intervention	ng/dL (Mean)
	Testosterone	DHT
Testosterone 1.25 mL (Applicator)	396	37.6
Testosterone 2.50 mL (Applicator)	641	57.7
Testosterone 3.75 mL (Applicator)	1024	78.9

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Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

Intervention	ng/dL (Mean)
	Testosterone	DHT
Testosterone 1.25 mL (Applicator)	173	21.1
Testosterone 2.50 mL (Applicator)	213	29.9
Testosterone 3.75 mL (Applicator)	250	37.3

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Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Intervention	ng*hr/dL (Mean)
	Testosterone	DHT
Testosterone 2.50 mL (Hand)	7809	1143

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Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

Intervention	hr (Median)
	Testosterone	DHT
Testosterone 1.25 mL (Applicator)	3.77	3.75
Testosterone 2.50 mL (Applicator)	3.77	3.78
Testosterone 3.75 mL (Applicator)	3.77	3.86

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Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

Intervention	hr (Median)
	Testosterone	DHT
Testosterone 1.25 mL (Applicator)	7.78	9.83
Testosterone 2.50 mL (Applicator)	10.81	11.0
Testosterone 3.75 mL (Applicator)	4.76	9.79

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Pharmacokinetics of Total Testosterone and DHT Measuring Tmax

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Intervention	hr (Median)
	Testosterone	DHT
Testosterone 2.50 mL (Hand)	1.86	1.86

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Pharmacokinetics of Total Testosterone and DHT Measuring Cmax

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Intervention	ng/dL (Mean)
	Testosterone	DHT
Testosterone 2.50 mL (Hand)	517	69.1

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Pharmacokinetics of Total Testosterone and DHT Measuring Cavg

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

Intervention	ng/dL (Mean)
	Testosterone	DHT
Testosterone 1.25 mL (Applicator)	240	28.7
Testosterone 2.50 mL (Applicator)	320	40.6
Testosterone 3.75 mL (Applicator)	429	51.0

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Pharmacokinetics of Total Testosterone and DHT Measuring Tmin

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Intervention	hr (Median)
	Testosterone	DHT
Testosterone 2.50 mL (Hand)	8.84	11.8

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Pharmacokinetics of Total Testosterone and DHT Measuring Cavg

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Intervention	ng/dL (Mean)
	Testosterone	DHT
Testosterone 2.50 mL (Hand)	325	47.6

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Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.

Descriptive statistics was used to present the outcome results. (NCT01464879)
Timeframe: Days 15-21, Days 22-28 & Days 29-35

Intervention	percentage of subjects (Number)
Testosterone 1.25 mL (Applicator)	16.7
Testosterone 2.50 mL (Applicator)	50.0
Testosterone 3.75 mL (Applicator)	77.8

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Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.

(NCT01464879)
Timeframe: Days 1-7

Intervention	percentage of subjects (Number)
Testosterone 2.50 mL (Hand)	50

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Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)

(NCT01464879)
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

Intervention	ng*hr/dL (Mean)
	Testosterone	DHT
Testosterone 1.25 mL (Applicator)	5768	688
Testosterone 2.50 mL (Applicator)	7686	974
Testosterone 3.75 mL (Applicator)	10295	1223

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Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score

Change in BPI Average Change from Baseline Pain Score to Month Six Average Pain Score. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: Baseline and 6 months

Intervention	score on a scale (Mean)
Arm II (Placebo)	-2.2
Arm I (Testosterone)	-1.9

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Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness)

Change in average joint stiffness from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: baseline and month 3

Intervention	score on a scale (Mean)
Arm II (Placebo)	-2.0
Arm I (Testosterone)	-2.2

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"The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL How Bothered Are You by Hot Flashes"

"The change of menopause specific quality of life from baseline to month 3 as measured by MENQOL how bothered are you by Hot Flashes. This is one question from the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks How bothered are you by hot flashes or flushes. This is collected on a scale ranging from 0=Not at all bothered t 6=Extremely bothered, with higher values being worse." (NCT01573442)
Timeframe: baseline and month 3

Intervention	score on a scale (Mean)
Arm II (Placebo)	-1.4
Arm I (Testosterone)	-1.4

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Change in BPI Average Pain From Baseline to Month 1-6

Change in BPI Average Pain from baseline to month 1-6. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: Baseline and months 1-6

Intervention	score on a scale (Mean)
	From baseline to month 1	From baseline to month 2	From baseline to month 3	From baseline to month 4	From baseline to month 5	From baseline to month 6
Arm I (Testosterone)	-1.7	-1.9	-2.0	-2.4	-2.0	-1.9
Arm II (Placebo)	-1.2	-1.9	-1.9	-2.1	-2.1	-2.2

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Change in Hot Flash Frequency From Baseline to Week 8

Change in hot flash frequency from baseline to week 8. Hot flash frequency is a count of the number of hot flashes per day and is a number from 0 to infinity. Higher values are worse. (NCT01573442)
Timeframe: baseline and week 8

Intervention	hot flashes/day (Mean)
Arm II (Placebo)	-10.9
Arm I (Testosterone)	-11.4

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Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment

"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below." (NCT01573442)
Timeframe: Up to 6 months

Intervention	Participants (Count of Participants)
	grade 3	grade 4
Arm I (Testosterone)	8	1
Arm II (Placebo)	4	1

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The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA.

The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. Change in general activity from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: baseline and month 3

Intervention	score on a scale (Mean)
Arm II (Placebo)	-2.1
Arm I (Testosterone)	-2.1

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The Change of Libido From Baseline to Month 3 as Measured by the MENQOL

"Change in how bothered are you by decreased sex drive from baseline to month 3. This is assessed using one question off of the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks How bothered are you by a decrease in your sexual drive. This is collected on a scale ranging from 0=Not at all bothered to 6=Extremely bothered, with higher values being worse." (NCT01573442)
Timeframe: baseline and month 3

Intervention	score on a scale (Mean)
Arm II (Placebo)	-0.5
Arm I (Testosterone)	-1.3

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Number of Patients Who Reported Alopecia Using CTCAE 4.0

The number of patients who reported alopecia using CTCAE 4.0 is reported below for each arm. (NCT01573442)
Timeframe: Up to 6 months

Intervention	Participants (Count of Participants)
Arm II (Placebo)	0
Arm I (Testosterone)	0

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Number of Patients Who Reported Acne Using CTCAE 4.0

The number of patients who reported acne using CTCAE 4.0 is reported below for each arm. (NCT01573442)
Timeframe: Up to 6 months

Intervention	Participants (Count of Participants)
Arm II (Placebo)	0
Arm I (Testosterone)	0

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Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3

The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: From baseline to 3 months

Intervention	score on a scale (Mean)
Arm II (Placebo)	-1.9
Arm I (Testosterone)	-2.0

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Change in BPI Worst Pain From Baseline to Month 3

Change in BPI Worst Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: baseline and month 3

Intervention	score on a scale (Mean)
Arm II (Placebo)	-2.5
Arm I (Testosterone)	-2.4

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Change in BPI Pain Right Now From Baseline to Month 3

Change in BPI Pain right now from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: baseline and month 3

Intervention	score on a scale (Mean)
Arm II (Placebo)	-1.6
Arm I (Testosterone)	-2.1

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Change in BPI Least Pain From Baseline to Month 3

Change in BPI Least Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. (NCT01573442)
Timeframe: baseline and month 3

Intervention	score on a scale (Mean)
Arm II (Placebo)	-1.0
Arm I (Testosterone)	-1.3

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Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2

This test evaluates many aspects of motor functioning including fine and gross motor skills, visual motor integration, motor planning, and motor coordination. Possible scores range from 20-80, with higher scores indicating a better outcome. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	score on a scale (Mean)
	Baseline	1 Year
Placebo Gel	35.52	37.17
Testosterone Gel 1%	39.92	41.34

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Change From Baseline on the Conners Parent Rating Scales: Anxiety

This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100 (Mean T-score 50), with higher scores indicating a worse outcome. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	score on a scale (Mean)
	Baseline	1 Year
Placebo Gel	62.2	62.8
Testosterone Gel 1%	59.7	54.0

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Change From Baseline on the Wechsler Intelligence Scale for Children - Fourth Edition

This standardized assessment of cognitive functioning allows for evaluation of verbal and nonverbal cognitive skills, working memory, and processing speed. Possible full scale IQ scores range from 40-180 (mean 100), with higher scores indicating a better outcome. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	score on a scale (Mean)
	Baseline	1 Year
Placebo Gel	83.9	84.6
Testosterone Gel 1%	86.8	88.7

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Change From Baseline on the Vineland Adaptive Behavior Scales - 2nd Edition

The Vineland-2 is an interview evaluating adaptive skills in the areas of communication, daily living skills, social skills, and motor skills. Possible scores range from 20 to 160 (mean 100), with higher scores indicating a better outcome. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	score on a scale (Mean)
	Baseline	Change at 1 year
Placebo Gel	75.8	78.4
Testosterone Gel 1%	78.7	82.2

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Change From Baseline on the Comprehensive Test of Phonological Processing

This standardized test evaluates reading and language skills. Possible scores range from 20-200 (Mean Standard Score 100), with higher scores indicating a better outcome. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	score on a scale (Mean)
	Baseline	Change at 1 Year
Placebo Gel	78.1	77.4
Testosterone Gel 1%	77.0	77.1

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Change From Baseline on the Delis-Kaplan Executive Function System

A collection of subtests from the Delis-Kaplan Executive Function System will be used to evaluate different domains of executive functions including planning, problem solving, fluency, inhibition, and working memory. Possible scaled scores range from 0-20 (mean of 10), with higher scores indicating better performance. The value of the change in scaled score from baseline is reported. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	Scaled scores (Mean)
	Verbal Fluency	Color-Word Interference	Sorting	20 Questions
Placebo Gel	1.29	0.65	0.76	1.59
Testosterone Gel 1%	-0.72	1.28	0.75	0.60

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Change From Baseline on the Conners Parent Rating Scales: Social Skills

This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100, with higher scores indicating a worse outcome. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	score on a scale (Mean)
	Baseline	1 Year
Placebo Gel	66.4	63.2
Testosterone Gel 1%	64.3	62.7

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Change From Baseline on the Conners Parent Rating Scales: Emotional Lability

This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100, with higher scores indicating a worse outcome. (NCT01585831)
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Intervention	score on a scale (Mean)
	Baseline	1 Year
Placebo Gel	61.3	54.4
Testosterone Gel 1%	59.4	57.3

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Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity

Intervention	score on a scale (Mean)
	Baseline	1 Year
Placebo Gel	57.2	54.4
Testosterone Gel 1%	60.7	53.4

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Change From Baseline on the Conners Parent Rating Scales: DSM Attention

Intervention	score on a scale (Mean)
	Baseline	1 Year
Placebo Gel	62.8	59.3
Testosterone Gel 1%	64.2	58.1

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Strength

Changes in muscle strength from the start of rehabilitation to 6, 12, and 24 weeks following surgery between the two groups in the injured limb. (NCT01595581)
Timeframe: 6, 12, and 24 weeks post surgery

Intervention	Nm (Mean)
	6 weeks post op	12 weeks post op	24 weeks post op
Placebo	-33.4	-6.6	19.0
Testosterone	-53.5	-18.3	19.2

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KOOS Scores

"Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) from 2 weeks prior to surgery to 6, 12, and 24 weeks post surgery.~KOOS is scored from 0 to 100 with 0 representing extreme knee problems and 100 representing normal knee function." (NCT01595581)
Timeframe: 6 weeks, 12 weeks, 24 weeks post surgery

Intervention	score on a scale (Mean)
	6 weeks post op	12 weeks post op	24 weeks post op
Placebo	65.5	73.2	86.6
Testosterone	63.2	76.7	84

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Changes in Lean Mass

Relative changes in lean mass from 2 weeks prior to surgery to 6 weeks, 12 weeks, and 24 weeks following surgery between the two groups. (NCT01595581)
Timeframe: 6, 12, and 24 weeks post operative

Intervention	kg (Mean)
	6 weeks post op	12 weeks post op	24 weeks post op
Placebo	-0.1	0.01	1.05
Testosterone	2.8	2.16	2.13

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Metabolic Profile

Basal Metabolic Rate (NCT01652040)
Timeframe: 16 weeks

Intervention	kcal/day (Mean)
	Baseline	Post-Intervention (After 16 weeks)
RT+Tp	1525	1665
Testosterone Replacement Patches (Tp)	1491	1502

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Body Composition

Changes in body composition fat mass (NCT01652040)
Timeframe: 16 weeks

Intervention	percentage of fat mass (Mean)
	Baseline	Post-Intervention (After 16 weeks)
RT+Tp	31.84	30.75
Testosteroe Replacement Patches (Tp)	33.4	32.12

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Pharmacokinetics of DHT Measuring Tmin

A validated LC/MS/MS method was used to determine the levels of DHT. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	hour (Median)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	0	8.00	16.0	12.0	12.0

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Pharmacokinetics of DHT Measuring Tmax

A validated LC/MS/MS method was used to determine the levels of DHT. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	hour (Median)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	6	4.08	2.11	3.98	3.97

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The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL

The data were presented using descriptive statistics. No statistical analysis was performed. (NCT01665599)
Timeframe: Day 90

Intervention	percentage of participants (Number)
	23 mg	46 mg	69 mg	Overall
Testosterone Gel (FE 999303)	2.9	4.7	77.9	85.5

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Pharmacokinetics of DHT Measuring Cmin

A validated LC/MS/MS method was used to determine the levels of DHT. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	18.0	45.4	35.7	42.8	42.4

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Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire

"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:~Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function." (NCT01665599)
Timeframe: Day 91

Intervention	units on a scale (Mean)
Testosterone Gel (FE 999303)	13.8

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The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL

The data were presented using descriptive statistics. No statistical analysis was performed. (NCT01665599)
Timeframe: Day 1

Intervention	percentage of participants (Number)
Testosterone Gel (FE 999303)	51.7

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Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire

"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).~The data were presented using descriptive statistics." (NCT01665599)
Timeframe: Day 91

Intervention	units on a scale (Mean)
	Severity domain score	Distress domain score	Degree of interference domain score	Timing domain score	GFI score
Testosterone Gel (FE 999303)	-5.3	-2.0	-18.9	-2.8	-11.4

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Change From Baseline in the SF-12 Health Questionnaire

"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:~PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)~MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)~The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and standard deviation of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~The data were presented using descriptive statistics." (NCT01665599)
Timeframe: Day 91

Intervention	units on a scale (Mean)
	Physical Component Summary (PCS)	Mental Component Summary (MCS)
Testosterone Gel (FE 999303)	3.7	7.9

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Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ

A validated LC/MS/MS method was used to determine the levels of DHT. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng*hr/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	982	1,537	1,329	1,604	1,582

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Pharmacokinetics of DHT Measuring Cave

A validated LC/MS/MS method was used to determine the levels of DHT. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	40.8	63.7	55.1	66.3	65.4

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Pharmacokinetics of DHT Measuring Cmax

A validated LC/MS/MS method was used to determine the levels of DHT. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	58.7	92.1	82.5	108	106

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Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)

A validated LC/MS/MS method was used to determine the levels of total testosterone. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	hour (Median)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	0	8.00	12.1	12.0	12.0

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Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)

A validated LC/MS/MS method was used to determine the levels of total testosterone. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	hour (Median)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	4	4	2.01	2.03	2.03

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Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)

A validated LC/MS/MS method was used to determine the levels of total testosterone. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	201	317	219	222	225

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Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)

A validated LC/MS/MS method was used to determine the levels of total testosterone. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	490	944	916	1,432	1,382

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Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)

A validated LC/MS/MS method was used to determine the levels of total testosterone. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	316	515	407	495	489

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Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)

A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone. (NCT01665599)
Timeframe: Day 1; Day 90

Intervention	ng*hr/dL (Mean)
	Day 1; 46 mg (n=180)	Day 90; 23 mg (n=5)	Day 90; 46 mg (n=12)	Day 90; 69 mg (n=155)	Day 90; all doses (n=172)
Testosterone Gel (FE 999303)	7,616	12,433	9,835	11,967	11,825

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Insulin Sensitivity Quantified by Matsuda Index

Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*2+PG90*2+PG120)/8*(FPI+PI30*2+PI60*2+PI90*2+PI)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60,90, and 120 minutes after oral glucose load; PI30,60,90, and 120=plasma insulin levels sampled at 30,60,90, and 120 minutes after the oral glucose load (NCT01686828)
Timeframe: 4 weeks

Intervention	units on a scale (Median)
Acyline & Placebo Gel & Placebo Pill	5.0
Acyline & Testosterone Gel 1.25g/d & Placebo Pill	9.4
Acyline & Testosterone Gel 5g/d & Placebo Pill	7.2
Acyline & Testosterone Gel & Letrozole	7.3

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Changes in Adipose Tissue Gene Expression

We examined whether differences in lipoprotein lipase expression would be evident across study treatment groups. RNA was isolated from whole adipose tissue gene expression, and complementary DNA (cDNA) was synthesized from 1.5 ug of RNA per sample. Gene expression was measured by polymerase chain reaction (PCR) using predesigned TaqMan® Gene Expression Assays. Standard curves were included on each plate, so Ct values were converted to copy numbers of the target gene. Expression values were normalized to the geometric mean of the housekeeping genes phosphoglycerate kinase and 18s. (NCT01686828)
Timeframe: 4 weeks

Intervention	gene copy number per ng RNA (Mean)
Acyline + Placebo Gel + Placebo Pills	7493
Acyline + Testosterone Gel (1.25g/d) + Placebo Pills	8224
Acyline + Testosterone Gel (5g/d) + Placebo Pills	7885
Acyline + Testosterone Gel (5g/d) + Letrozole	8320

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Changes in Body Composition

Fat mass and lean mass were measured by dual energy X-ray absorptiometry (DEXA) at baseline and at the end of the 4 week treatment period (NCT01686828)
Timeframe: 4 weeks

,,,

Intervention	kg (Mean)
	Change in fat mass	Change in lean mass
Acyline & Placebo Gel & Placebo Pill	1.1	-1.2
Acyline & Testosterone Gel & Letrozole	0.5	-0.3
Acyline & Testosterone Gel 1.25g/d & Placebo Pill	0.7	-1.4
Acyline & Testosterone Gel 5g/d & Placebo Pill	-0.4	0.0

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FSFI Pain Domain

The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome. (NCT01697345)
Timeframe: Baseline, 4 weeks

Intervention	units on a scale (Mean)
FSFI Pain Domain Score (Pretest)	0.933
FSFI Pain Domain Score (Posttest)	3.500

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FSFI Orgasm Domain

The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome. (NCT01697345)
Timeframe: Baseline, 4 weeks

Intervention	units on a scale (Mean)
FSFI Orgasm Domain Score (Pretest)	1.733
FSFI Orgasm Domain Score (Posttest)	2.933

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FSFI Arousal Domain

The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome. (NCT01697345)
Timeframe: Baseline, 4 weeks

Intervention	units on a scale (Mean)
FSFI Arousal Domain Score (Pretest)	1.200
FSFI Arousal Domain Score (Posttest)	2.825

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FSFI Desire Domain

The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome. (NCT01697345)
Timeframe: Baseline, 4 weeks

Intervention	units on a scale (Mean)
FSFI Desire Domain Score (Pretest)	1.350
FSFI Desire Domain Score (Posttest)	2.650

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FSFI Lubrication Domain

The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome. (NCT01697345)
Timeframe: Baseline, 4 weeks

Intervention	units on a scale (Mean)
FSFI Lubrication Domain Score (Pretest)	1.175
FSFI Lubrication Domain Score (Posttest)	2.675

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FSFI Satisfaction Domain

The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome. (NCT01697345)
Timeframe: Baseline, 4 weeks

Intervention	units on a scale (Mean)
FSFI Satisfaction Domain Score (Pretest)	2.300
FSFI Satisfaction Domain Score (Posttest)	4.200

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Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study

(NCT01697345)
Timeframe: After 4 weeks

Intervention	participants (Number)
Continued Vaginal Testosterone Therapy	11
Did Not Continue Vaginal Testosterone Therapy	1

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Total Female Sexual Function Index (FSFI) Score

The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction. (NCT01697345)
Timeframe: Baseline, 4 weeks

Intervention	units on a scale (Mean)
FSFI Total Score (Pretest)	8.691
FSFI Total Score (Postteset)	18.783

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Absolute Change From Baseline in Hct

Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume. (NCT01699178)
Timeframe: Approximately 365 days

Intervention	percent (Mean)
Oral TU	0.38
Transdermal T-gel	0.37

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Absolute Change From Baseline in Prostate Volume

Intervention	cc (Mean)
Oral TU	1.09
Transdermal T-gel	0.40

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Absolute Change From Baseline in T Cholesterol

Intervention	mg/dL (Mean)
Oral TU	0.2
Transdermal T-gel	8.2

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Absolute Change From Baseline in LDL

Intervention	mg/dL (Mean)
Oral TU	-1.5
Transdermal T-gel	6.0

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Absolute Change From Baseline in Hgb

Intervention	g/dL (Mean)
Oral TU	0.36
Transdermal T-gel	0.36

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Absolute Change From Baseline in HDL

Intervention	mg/dL (Mean)
Oral TU	2.4
Transdermal T-gel	4.0

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Domain Scores for the Short Form-12 (SF-12) Questionnaire

"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:~PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)~MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)~The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~The data were presented using descriptive statistics." (NCT01703741)
Timeframe: At Month 6

Intervention	units on a scale (Mean)
	General health domain	Physical functioning domain	Role-physical domain	Bodily pain domain	Physical component summary	Role-emotional domain	Mental health domain	Vitality domain	Social functioning domain	Mental component summary
Testosterone Gel (FE 999303)	54.3	51.7	50.2	51.1	51.9	48.8	52.7	53.1	51.2	51.2

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Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire

"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).~The data were presented using descriptive statistics." (NCT01703741)
Timeframe: At Month 6

Intervention	units on a scale (Mean)
	Severity domain	Distress domain	Degree of interference in daily activities	Timing domain	Global fatigue index score
Testosterone Gel (FE 999303)	6.6	2.8	28.3	10.1	15.3

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Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire

"Data collected from the five domains of sexual functions were summarized by descriptive statistics.~The domains are:~Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain." (NCT01703741)
Timeframe: At Month 6

Intervention	units on a scale (Mean)
	Erectile function domain	Orgasmic function domain	Sexual desire domain	Intercourse satisfaction domain	Overall satisfaction domain
Testosterone Gel (FE 999303)	19.8	7.3	7.0	8.7	6.7

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Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone

"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics." (NCT01703741)
Timeframe: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)

Intervention	ng/dL (Mean)
	Total testosterone at 23 mg	Total testosterone at 46 mg	Total testosterone at 69 mg	Total testosterone all doses	Dihydrotestosterone at 23 mg	Dihydrotestosterone at 46 mg	Dihydrotestosterone at 69 mg	Dihydrotestosterone all doses
Testosterone Gel (FE 999303)	322	438	449	433	56.6	69.3	72.4	69.7

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Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone

Intervention	ng*hr/dL (Mean)
	Total testosterone at 23 mg	Total testosterone at 46 mg	Total testosterone at 69 mg	Total testosterone all doses	Dihydrotestosterone at 23 mg	Dihydrotestosterone at 46 mg	Dihydrotestosterone at 69 mg	Dihydrotestosterone all doses
Testosterone Gel (FE 999303)	7732	10583	10842	10451	1361	1675	1751	1685

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Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.

"Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics." (NCT01703741)
Timeframe: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)

Intervention	percentage of subjects (Number)
Testosterone Gel (FE 999303)	82.1

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Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire

"In ADAM questionnaire, subjects had to respond in yes or no to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer (yes) to questions 1 or 7, or to any 3 other questions.~The data were presented using descriptive statistics." (NCT01703741)
Timeframe: At Month 6

Intervention	percentage of subjects (Number)
Testosterone Gel (FE 999303)	44.1

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Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone

Intervention	hour (Median)
	Total testosterone at 23 mg	Total testosterone at 46 mg	Total testosterone at 69 mg	Total testosterone all doses	Dihydrotestosterone at 23 mg	Dihydrotestosterone at 46 mg	Dihydrotestosterone at 69 mg	Dihydrotestosterone all doses
Testosterone Gel (FE 999303)	3.09	2.11	3.97	3.88	3.96	4.00	4.00	4.00

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Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL

The data were presented using descriptive statistics. (NCT01703741)
Timeframe: At Month 6

Intervention	percentage of subjects (Number)
	Total testosterone level between 1500-1799 ng/dL	Total testosterone level between 1800-2499 ng/dL	Total testosterone level above 2500 ng/dL
Testosterone Gel (FE 999303)	6.7	2.9	1.9

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Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL

The data were presented using descriptive statistics. (NCT01703741)
Timeframe: At Month 3

Intervention	percentage of subjects (Number)
	Total testosterone level between 1500-1799 ng/dL	Total testosterone level between 1800-2499 ng/dL	Total testosterone level above 2500 ng/dL
Testosterone Gel (FE 999303)	6.6	5.7	2.8

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Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL

Intervention	percentage of subjects (Number)
	Total testosterone level between 1500-1799 ng/dL	Total testosterone level between 1800-2499 ng/dL	Total testosterone level above 2500 ng/dL
Testosterone Gel (FE 999303)	5.7	2.8	2.8

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Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone

Intervention	ng/dL (Mean)
	Total testosterone at 23 mg	Total testosterone at 46 mg	Total testosterone at 69 mg	Total testosterone all doses	Dihydrotestosterone at 23 mg	Dihydrotestosterone at 46 mg	Dihydrotestosterone at 69 mg	Dihydrotestosterone all doses
Testosterone Gel (FE 999303)	162	201	219	207	34.8	43.5	44.8	43.4

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Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone

Intervention	ng/dL (Mean)
	Total testosterone at 23 mg	Total testosterone at 46 mg	Total testosterone at 69 mg	Total testosterone all doses	Dihydrotestosterone at 23 mg	Dihydrotestosterone at 46 mg	Dihydrotestosterone at 69 mg	Dihydrotestosterone all doses
Testosterone Gel (FE 999303)	747	1085	999	1008	88.7	111	114	111

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Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment

Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4. (NCT01717768)
Timeframe: 15 days

,,,,,,,,

Intervention	percentage of subjects (Number)
	Percentage of subjects with Cmax ≤ 1500 ng/dL afte	Percentage of subjects with Cmax ≥ 1800 and ≤ 2500	Percentage of subjects with Cmax > 2500 ng/dL afte
Part 1: 120 mg BID	100	0	0
Part 1: 240 mg BID	100	0	0
Part 2: 120 mg BID	94.1	0	0
Part 4 Cohort 1: 60 mg BID	100	0	0
Part 4 Cohort 1: 60 mg TID	100	0	0
Part 4 Cohort 2: 90 mg BID	100	0	0
Part 4 Cohort 2: 90 mg TID	100	0	0
Part 4 Cohort 3: 180 mg QD	100	0	0
Part 4 Cohort 4: 120 mg BID	93.75	6.25	0

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Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002

Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4. (NCT01717768)
Timeframe: 15 days

Intervention	percentage of participants (Number)
Part 1: 120 mg BID	59
Part 1: 240 mg BID	31
Part 2: 120 mg BID	35
Part 4 Cohort 1: 60 mg BID	41
Part 4 Cohort 1: 60 mg TID	53
Part 4 Cohort 2: 90 mg BID	19
Part 4 Cohort 2: 90 mg TID	20
Part 4 Cohort 3: 180 mg QD	31
Part 4 Cohort 4: 120 mg BID	27

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AUC 0-24 Hrs After 120 mg Dose of TSX-002

AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. (NCT01717768)
Timeframe: 24 hrs

Intervention	hr×ng/dL (Median)
Part 3:120 mg QD Treatment A	1941
Part 3:120 mg QD Treatment B	2117
Part 3:120 mg QD Treatment C	1516

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Cavg 0-24 Hrs (ng/dL) After 120 mg Dose

PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects. (NCT01717768)
Timeframe: 24 hrs

Intervention	ng/dL (Least Squares Mean)
Part 3:120 mg QD Treatment A	296
Part 3:120 mg QD Treatment B	297
Part 3:120 mg QD Treatment C	273

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Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone

The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. (NCT01725451)
Timeframe: Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug

Intervention	nanograms* hours per deciliter (ng*h/dL) (Geometric Mean)
Testosterone Unshaved	2120
Testosterone Unshaved + Deodorant Spray	2400
Testosterone Unshaved + Deodorant Antiperspirant Spray	2970
Testosterone Unshaved + Deodorant Antiperspirant Stick	2880
Testosterone Shaved	3110
Testosterone Shaved + Deodorant Antiperspirant Spray	2070

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Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone

The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. (NCT01725451)
Timeframe: Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug

Intervention	nanograms per deciliter (ng/dL) (Geometric Mean)
Testosterone Unshaved	214
Testosterone Unshaved + Deodorant Spray	209
Testosterone Unshaved + Deodorant Antiperspirant Spray	234
Testosterone Unshaved + Deodorant Antiperspirant Stick	202
Testosterone Shaved	231
Testosterone Shaved + Deodorant Antiperspirant Spray	151

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Patients With PSA <4 ng/mL at the End of the Study

To determine the clinical effects of BAT in men with recurrent prostate cancer as first line therapy. This will be accomplished by assessing the number of patients achieving a PSA <4 ng/ml at the end of the trial. (NCT01750398)
Timeframe: 18 months

Intervention	participants (Number)
ADT Plus IM Testosterone	17

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Change in C-telopeptides

Change in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months) (NCT01750398)
Timeframe: 6 months and 9 months

Intervention	pg/ml (Mean)
ADT Plus IM Testosterone	-159.77

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Radiographic or Clinical Progression

To evaluate the number of men treated per the bipolar androgen therapy phase of the trial who developed radiographic or clinical progression. Radiographic progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was defined as new symptoms that can be attributed to progressive prostate cancer (e.g. new/worsening pain, urinary obstruction, cord compression, bone fractures). (NCT01750398)
Timeframe: 18 months

Intervention	participants (Number)
	Patients with radiographic/clinical progression	Patients without radiographic/clinical progression
ADT Plus IM Testosterone	6	23

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Quality of Life Survey

"To measure quality of life through the RAND-SF36 (short-form 36 questionnaire) Quality of Life Survey, the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P), the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS) and a visual pain scale. Note that for all scales, higher scores indicate better quality of life/function, with the exception being the visual pain scale, where a higher score indicates more pain.~RAND-SF36: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Range is from 0 to 100.~FACT-P: A tool used for assessing the health-related quality of life in men with prostate cancer. Range is from 0 to 156.~IIEF: Is a measure of erectile function. Range is from 5 to 25. IPSS: A tool used to measure symptoms related to prostatic disease. Range is from 0 to 35.~Visual pain scale: A tool used to track pain level. Range is from 0 to 10." (NCT01750398)
Timeframe: 3 months

Intervention	units on a scale (Median)
	Change in SF-36 after round 1 of BAT	Change in FACT-P after round 1 of BAT	Change in IIEF after round 1 of BAT	Change in IPSS after round 1 of BAT
ADT Plus IM Testosterone	3.2	3.5	10	0

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Complete PSA Response

To evaluate the number of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) at the end of the study (NCT01750398)
Timeframe: 18 months

Intervention	participants (Number)
	Patients with PSA <0.2 ng/ml	Patients with PSA ≥0.2 ng/ml
ADT Plus IM Testosterone	3	26

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Change in Weight

Change in weight is measured from baseline to 6 months (i.e. following ADT lead in) and from 6 months to 9 months (i.e. from post-ADT to the end of cycle 1 of BAT). (NCT01750398)
Timeframe: Baseline, 6 months and 9 months.

Intervention	kg (Mean)
	Following ADT lead in	Following round 1 of BAT
ADT Plus IM Testosterone	2.08	1.21

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Change in Waist Circumference

(NCT01750398)
Timeframe: Bseline, 6 months and 9 months.

Intervention	cm (Mean)
	Following ADT lead in	Following round 1 of BAT
ADT Plus IM Testosterone	3.9	-1.09

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Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population

The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114. (NCT01765179)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114

Intervention	Participants (Count of Participants)
	Cmax less that 1500 ng/dL	Cmax between 1500 and 1800 ng/dL	Cmax >1800 to 2500 ng/dL	Cmax >2500 ng/dL
Oral Testosterone Undecanoate	95	10	7	4

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Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL

Intervention	Participants (Count of Participants)
Oral Testosterone Undecanoate	87

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Depressive Symptom Severity

Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale. (NCT01783574)
Timeframe: Week 8

Intervention	units on a scale (Mean)
Testosterone	15.3
Placebo	14.1

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Sexual Dysfunction

Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160. (NCT01783574)
Timeframe: Week 8

Intervention	units on a scale (Mean)
Testosterone	45.1
Placebo	47.5

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Fatigue

Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale. (NCT01783574)
Timeframe: Week 8

Intervention	units on a scale (Mean)
Testosterone	4.0
Placebo	3.7

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Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12

Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL). (NCT01816295)
Timeframe: Week 12

Intervention	participants (Number)
Placebo Solution	43
Testosterone Solution	217

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Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)

(NCT01816295)
Timeframe: Double Blind Baseline, Week 12, Open Label Baseline, Week 36

Intervention	participants (Number)
	Double-Blind Baseline (n=350, 347)	Week 12 (n=289, 299)	Open Label Baseline (n=269, 278)	Week 36 (n=219, 223)
Placebo Solution	1	3	0	4
Testosterone Solution	0	4	0	4

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Change From Baseline in Total International Prostate Symptom Score (IPSS)

The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates. (NCT01816295)
Timeframe: Baseline, Week 12, Week 36

Intervention	units on a scale (Least Squares Mean)
	Change from Baseline to Week 12	Change from Baseline to Week 36 (n=247, 255)
Placebo Solution	-0.7	-0.7
Testosterone Solution	-0.9	-0.7

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Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores

"The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with 5 corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates." (NCT01816295)
Timeframe: Baseline, Week 12

Intervention	units on a scale (Least Squares Mean)
Placebo Solution	6.3
Testosterone Solution	11.4

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Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores

"The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with 10 corresponding to Full of Energy or Not Tired at All (The Tiredness scale was reverse-mapped, as it was collected with 10 corresponding to Extreme Tiredness). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates." (NCT01816295)
Timeframe: Baseline, Week 12

Intervention	units on a scale (Least Squares Mean)
Placebo Solution	7.5
Testosterone Solution	10.5

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Change in Pain Ratings

Pain ratings will be assessed by self-report (4 items from Brief Pain Inventory). Change in pain ratings was assessed by examining the differences between pain ratings at baseline and week 8. Higher values are considered to be a worse outcome. The scale range is 0-10. (NCT01873989)
Timeframe: 8 weeks

Intervention	units on a scale (Mean)
Testosterone Replacement	1.8
Waitlist Control	1.8

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Number of Participants Demonstrating Abstinence

Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8. (NCT01873989)
Timeframe: 8 weeks

Intervention	Participants (Count of Participants)
Testosterone Replacement	5
Waitlist Control	4

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Change in Sexual Dysfunction From Baseline to Week 8

Decreased sexual dysfunction will be assessed using the Erectile Function (EF) subscale of the International Index of Erectile Function (IIEF). The EF subscale has 6 items scored on a zero to five Likert-type scale. Change in sexual dysfunction was calculated by subtracting the mean EF subscale score at week 8 from the mean EF subscale score at baseline. The range of the EF subscale is 0-30 (with higher scores representing greater functioning). The Cut-offs for the EF subscales are as follows: no erectile dysfunction (score 26-30), mild erectile dysfunction (22-25), mild to moderate erectile dysfunction(17-21), moderate erectile dysfunction (11-16), and severe erectile dysfunction (0-10). (NCT01873989)
Timeframe: 8 weeks

Intervention	units on a scale (Mean)
Testosterone Replacement	6.95
Waitlist Control	-1

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The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks

The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST (NCT01887418)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

Intervention	ng/dL (Mean)
QuickShot™ - 100 mg Treatment A	1345.6
QuickShot™ - 50 mg Treatment B	622.4
Delatestryl 200 mg IM Treatment C	261.9

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The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks

The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST (NCT01887418)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

Intervention	ng/dL (Mean)
QuickShot™ - 100 mg Treatment A	895.5
QuickShot™ - 50 mg Treatment B	422.4
Delatestryl 200 mg IM Treatment C	1658.7

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The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks

The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST (NCT01887418)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

Intervention	ng*hr/dL (Mean)
QuickShot™ - 100 mg Treatment A	150445.2
QuickShot™ - 50 mg Treatment B	70955.7
Delatestryl 200 mg IM Treatment C	278657.9

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Number of Patients in the PK Parameter Category

The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE (NCT01887418)
Timeframe: 6 weeks

Intervention	participants (Number)
QuickShot™ - 100 mg Treatment A	10
QuickShot™ - 50 mg Treatment B	12
Delatestryl 200 mg IM Treatment C	3

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Change From Baseline in Serum Testosterone Levels

Serum testosterone levels were measured by LC/MS-MS. (NCT01893281)
Timeframe: Baseline, Study Completion (Up to 9 Weeks)

Intervention	ng/dL (Mean)
Topical Testosterone Solution	354.8

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Percentage of Participants Achieving Normal Serum Testosterone Levels

Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) * 100. (NCT01893281)
Timeframe: Baseline through Study Completion (Up to 9 Weeks)

Intervention	percentage of participants (Number)
Topical Testosterone Solution	94.7

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Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level

"PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was very much better, a score of 4 indicated that the participant had experienced no change in energy level and a score of 7 indicated that the participant's energy level was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) * 100." (NCT01893281)
Timeframe: Study Days 15, 22, 36, 43, 57, 64 and endpoint

Intervention	percentage of participants (Number)
	Very much better - Day 15 (n=75)	Much better - Day 15 (n=75)	A little better - Day 15 (n=75)	No change - Day 15 (n=75)	A little worse - Day 15 (n=75)	Much worse - Day 15 (n=75)	Very much worse - Day 15 (n=75)	Very much better - Day 22 (n=76)	Much better - Day 22 (n=76)	A little better - Day 22 (n=76)	No change - Day 22 (n=76)	A little worse - Day 22 (n=76)	Much worse - Day 22 (n=76)	Very much worse - Day 22 (n=76)	Very much better - Day 36 (n=22)	Much better - Day 36 (n=22)	A little better - Day 36 (n=22)	No change - Day 36 (n=22)	A little worse - Day 36 (n=22)	Much worse - Day 36 (n=22)	Very much worse - Day 36 (n=22)	Very much better - Day 43 (n=22)	Much better - Day 43 (n=22)	A little better - Day 43 (n=22)	No change - Day 43 (n=22)	A little worse - Day 43 (n=22)	Much worse - Day 43 (n=22)	Very much worse - Day 43 (n=22)	Very much better - Day 57 (n=6)	Much better - Day 57 (n=6)	A little better - Day 57 (n=6)	No change - Day 57 (n=6)	A little worse - Day 57 (n=6)	Much worse - Day 57 (n=6)	Very much worse - Day 57 (n=6)	Very much better - Day 64 (n=6)	Much better - Day 64 (n=6)	A little better - Day 64 (n=6)	No change - Day 64 (n=6)	A little worse - Day 64 (n=6)	Much worse - Day 64 (n=6)	Very much worse - Day 64 (n=6)	Very much better - Endpoint (n=77)	Much better - Endpoint (n=77)	A little better - Endpoint (n=77)	No change - Endpoint (n=77)	A little worse - Endpoint (n=77)	Much worse - Endpoint (n=77)	Very much worse - Endpoint (n=77)
Topical Testosterone Solution	4.00	16.00	44.00	36.00	0.00	0.00	0.00	7.89	27.63	40.79	22.37	1.32	0.00	0.00	4.55	18.18	50.00	22.73	4.55	0.00	0.00	4.55	27.27	40.91	22.73	4.55	0.00	0.00	0.00	33.33	50.00	16.67	0.00	0.00	0.00	16.67	16.67	33.33	33.33	0.00	0.00	0.00	10.39	29.87	35.06	22.08	2.60	0.00	0.00

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Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive

"PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was very much better, a score of 4 indicated that the participant had experienced no change in sexual drive and a score of 7 indicated that the participant's sexual drive was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) * 100." (NCT01893281)
Timeframe: Study Days 15, 22, 36, 43, 57, 64 and endpoint

Intervention	percentage of participants (Number)
	Very much better - Day 15 (n=76)	Much better - Day 15 (n=76)	A little better - Day 15 (n=76)	No change - Day 15 (n=76)	A little worse - Day 15 (n=76)	Much worse - Day 15 (n=76)	Very much worse - Day 15 (n=76)	Very much better - Day 22 (n=76)	Much better - Day 22 (n=76)	A little better - Day 22 (n=76)	No change - Day 22 (n=76)	A little worse - Day 22 (n=76)	Much worse - Day 22 (n=76)	Very much worse - Day 22 (n=76)	Very much better - Day 36 (n=22)	Much better - Day 36 (n=22)	A little better - Day 36 (n=22)	No change - Day 36 (n=22)	A little worse - Day 36 (n=22)	Much worse - Day 36 (n=22)	Very much worse - Day 36 (n=22)	Very much better - Day 43 (n=22)	Much better - Day 43 (n=22)	A little better - Day 43 (n=22)	No change - Day 43 (n=22)	A little worse - Day 43 (n=22)	Much worse - Day 43 (n=22)	Very much worse - Day 43 (n=22)	Very much better - Day 57 (n=6)	Much better - Day 57 (n=6)	A little better - Day 57 (n=6)	No change - Day 57 (n=6)	A little worse - Day 57 (n=6)	Much worse - Day 57 (n=6)	Very much worse - Day 57 (n=6)	Very much better - Day 64 (n=6)	Much better - Day 64 (n=6)	A little better - Day 64 (n=6)	No change - Day 64 (n=6)	A little worse - Day 64 (n=6)	Much worse - Day 64 (n=6)	Very much worse - Day 64 (n=6)	Very much better - Endpoint (n=77)	Much better - Endpoint (n=77)	A little better - Endpoint (n=77)	No change - Endpoint (n=77)	A little worse - Endpoint (n=77)	Much worse - Endpoint (n=77)	Very much worse - Endpoint (n=77)
Topical Testosterone Solution	3.95	11.84	44.74	38.16	1.32	0.00	0.00	5.26	25.00	39.47	30.26	0.00	0.00	0.00	0.00	22.73	45.45	31.82	0.00	0.00	0.00	4.55	22.73	36.36	31.82	4.55	0.00	0.00	0.00	50.00	0.00	50.00	0.00	0.00	0.00	16.67	33.33	0.00	50.00	0.00	0.00	0.00	7.79	27.27	35.06	28.57	1.30	0.00	0.00

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Pregnancy Rate

(NCT01909141)
Timeframe: 3 months

Intervention	participants (Number)
Arm 1:Letrozole-pioglitazone -Metformin Group	28
Arm 2: Clomiphene Citrate-pioglitazone-metformin	24

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Number of Follicles>18mm.

(NCT01909141)
Timeframe: 3 months

Intervention	follicles (Mean)
Arm 1:Letrozole-pioglitazone -Metformin Group	1.44
Arm 2: Clomiphene Citrate-pioglitazone-metformin	1.5

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Endometrial Thickness

(NCT01909141)
Timeframe: 3 months

Intervention	mm (Mean)
Arm 1:Letrozole-pioglitazone -Metformin Group	10.56
Arm 2: Clomiphene Citrate-pioglitazone-metformin	9.68

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Ovulation Rate

(NCT01909141)
Timeframe: 3 months

Intervention	percentage of all cycles (Number)
Arm 1:Letrozole-pioglitazone -Metformin Group	93
Arm 2: Clomiphene Citrate-pioglitazone-metformin	108

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Safety of Pioglitazone as Regards Serum Creatinine

serum creatinine was measured at the end of the study period (after 3 months) in both groups. (NCT01909141)
Timeframe: 3 months

Intervention	mg/dL (Mean)
Arm 1:Letrozole-pioglitazone -Metformin Group	0.62
Arm 2: Clomiphene Citrate-pioglitazone-metformin	0.57

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Amount of Testosterone Following Laundering

This is a summary of the amounts of testosterone measured on a 10 cm × 10 cm of material excised from the underarm area of washed t-shirt halves following laundering in a standard washing machine. (NCT02004132)
Timeframe: 12 hours after application of study drug

Intervention	µg (Mean)
Axiron 120 mg	260

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Amount of Testosterone on T-shirts

This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves. (NCT02004132)
Timeframe: 12 hours after application of study drug

Intervention	micrograms (µg) (Mean)
Axiron 120 mg	7603

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Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts

"This is a summary of the amounts of testosterone measured on unworn textile items washed with t-shirt halves exposed to testosterone in a standard washing machine. Total amounts of testosterone on each laundered item other than the t-shirt halves was calculated based on the weight of the fabric sample analyzed and the total weight of the item, assuming a uniform distribution of testosterone across each item as:~(weight of laundered item / weight of laundered sample) x amount of testosterone on laundered sample." (NCT02004132)
Timeframe: 12 hours after application of study drug

Intervention	µg (Mean)
	Bleached Cotton Terry Cloth	Wool Jersey Knit Fabric	56/44 Cotton/Linen	Texturized Dacron 56T Double	87/13 Nylon/Lycra Knit
Axiron 120 mg	308	122	441	68.7	10402

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Disease Response as Defined by RECIST 1.1 (Soft Tissue Lesions) and PCWG2 Criteria (Bone Lesions)

Number of participants with complete or partial response post-BAT as defined by RECIST 1.1 (for soft tissue lesions) and PCWG2 criteria (for bone disease), or return to castration-only post-BAT. (NCT02090114)
Timeframe: up to 18 months

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	6
Cohort B: Post-abiraterone	2
Cohort C: Castration Only	4
Cohort D: Mutation	0

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Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy (BAT)

Number of participants with ≥50% PSA reduction from pre-BAT baseline level (NCT02090114)
Timeframe: up to 18 months

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	9
Cohort B: Post-abiraterone	5
Cohort C: Castration Only	4
Cohort D: Mutation	2

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PSA Progression on BAT (Bipolar Androgen Therapy )

Time to PSA progression on BAT. Time to PSA progression on BAT is defined as the time from the date of initial dose of Testosterone to the date of the PSA measurement when it shows an ≥25% increase above the nadir value and confirmed by a repeat PSA 4 weeks later (PCWG2 criteria) during the treatment with BAT. (NCT02090114)
Timeframe: up to 18 months

Intervention	months (Median)
Cohort A:Post-enzalutamide	3.3
Cohort B: Post-abiraterone	3.2
Cohort C: Castration Only	0.93
Cohort D: Mutation	3

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PSA Progression on Enzalutamide or Abiraterone Acetate or Castrate Levels Post-BAT

Time to PSA progression on enzalutamide or abiraterone acetate or return to castrate levels of testosterone post-BAT, defined as the time from the date of re-initiation of enzalutamide or abiraterone acetate or castration-only therapy to the date of the PSA measurement when it shows an increase by ≥25% above the nadir value that occurred following re-initiation of enzalutamide or abiraterone acetate or castration-only therapy and confirmed by a repeat PSA 4 weeks later (PCWG2). (NCT02090114)
Timeframe: up to 18 months

Intervention	months (Median)
Cohort A:Post-enzalutamide	5.5
Cohort B: Post-abiraterone	3.7
Cohort C: Castration Only	NA

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PSA Response to Enzalutamide or Abiraterone Acetate Post Bipolar Androgen Therapy

Number of participants with ≥50% PSA reduction after enzalutamide or abiraterone acetate post-BAT from baseline (NCT02090114)
Timeframe: up to 24 months

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	15
Cohort B: Post-abiraterone	3
Cohort D: Mutation	2

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Safety and Tolerability as Assessed by Number of Participants With Adverse Events

Number of participants who experience adverse events, as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. (NCT02090114)
Timeframe: 18 months

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	30
Cohort B: Post-abiraterone	29
Cohort C: Castration Only	29
Cohort D: Mutation	7

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Quality of Life (QoL) as Assessed by FACIT-F Score

Functional Assessment of Chronic Illness Therapy, Fatigue Subscale (FACIT-F) assesses Fatigue with a total score range of 0-52, with a higher score reflecting better QoL. (NCT02090114)
Timeframe: up to 18 months

Intervention	score on a scale (Mean)
	Baseline	Cycle 1 Day 85
Cohort A:Post-enzalutamide	13.28	10.64
Cohort B: Post-abiraterone	16.86	13.85
Cohort C: Castration Only	13	11.55

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Quality of Life (QoL) as Assessed by IIEF

International Index of Erectile Function (IIEF-5) is a diagnostic tool for erectile dysfunction, with a total score range of 5-25, with the lowest score indicating a higher degree of dysfunction. (NCT02090114)
Timeframe: up to 18 months

Intervention	score on a scale (Mean)
	Baseline	BAT C1D85
Cohort A:Post-enzalutamide	8	24.13
Cohort B: Post-abiraterone	7.33	24.94
Cohort C: Castration Only	12.56	22.44

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Quality of Life (QoL) as Assessed by PANAS

Positive and Negative Affect Schedule (PANAS) is a self-report measure that is made up of two mood scales, one measuring positive affect and the other measuring negative affect, with a total score range from 10-50 with a higher score on the positive scale indicating greater levels of positive affect and a lower score on the negative scale indicating less of a negative affect. (NCT02090114)
Timeframe: up to 18 months

Intervention	score on a scale (Mean)
	Baseline	BAT C1D85
Cohort A:Post-enzalutamide	46.15	45.1
Cohort B: Post-abiraterone	48	45.22
Cohort C: Castration Only	41.24	44.48

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Quality of Life (QoL) as Assessed by RANDSF-36

RAND 36-Item Short Form (RANDSF-36) assesses physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health with a total score range of 0-100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100, with a higher score reflecting a better QoL. (NCT02090114)
Timeframe: up to 18 months

Intervention	score on a scale (Mean)
	Baseline	Cycle 1 Day 85
Cohort A:Post-enzalutamide	72.23	71.76
Cohort B: Post-abiraterone	64.36	73.97
Cohort C: Castration Only	69.72	73.40

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Change From Baseline in International Index of Erectile Function (IIEF) Score

"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:~Erectile function (6 items, questions 1-5 and 15) (Score range:1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function." (NCT02149264)
Timeframe: At Days 35 and 90

Intervention	units on a scale (Mean)
	Day 35	Day 90
Testosterone Gel (FE 999303)	8.4	14.4

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The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL

The data were presented using descriptive statistics. No statistical analysis was performed. (NCT02149264)
Timeframe: At 14, 35 and 56

Intervention	percentage of subjects (Number)
	Day 14	Day 35	Day 56
Testosterone Gel (FE 999303)	29.1	58.2	71.2

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Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone

A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. (NCT02149264)
Timeframe: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90

Intervention	hr (Median)
	Total testosterone on Day 14 at 23 mg dose	Total testosterone on Day 35 at 23 mg dose	Total testosterone on Day 35 at 46 mg dose	Total testosterone on Day 56 at 23 mg dose	Total testosterone on Day 56 at 46 mg dose	Total testosterone on Day 56 at 69 mg dose	Total testosterone on Day 90 at 23 mg dose	Total testosterone on Day 90 at 46 mg dose	Total testosterone on Day 90 at 69 mg dose	Dihydrotestosterone on Day 14 at 23 mg dose	Dihydrotestosterone on Day 35 at 23 mg dose	Dihydrotestosterone on Day 35 at 46 mg dose	Dihydrotestosterone on Day 56 at 23 mg dose	Dihydrotestosterone on Day 56 at 46 mg dose	Dihydrotestosterone on Day 56 at 69 mg dose	Dihydrotestosterone on Day 90 at 23 mg dose	Dihydrotestosterone on Day 90 at 46 mg dose	Dihydrotestosterone on Day 90 at 69 mg dose
Testosterone Gel (FE 999303)	2.04	2.15	2.00	2.00	2.08	2.00	4.02	2.02	2.08	3.97	3.04	2.94	2.00	2.08	3.87	4.12	3.75	3.95

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Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone

Intervention	ng/dL (Mean)
	Total testosterone on Day 14 at 23 mg dose	Total testosterone on Day 35 at 23 mg dose	Total testosterone on Day 35 at 46 mg dose	Total testosterone on Day 56 at 23 mg dose	Total testosterone on Day 56 at 46 mg dose	Total testosterone on Day 56 at 69 mg dose	Total testosterone on Day 90 at 23 mg dose	Total testosterone on Day 90 at 46 mg dose	Total testosterone on Day 90 at 69 mg dose	Dihydrotestosterone on Day 14 at 23 mg dose	Dihydrotestosterone on Day 35 at 23 mg dose	Dihydrotestosterone on Day 35 at 46 mg dose	Dihydrotestosterone on Day 56 at 23 mg dose	Dihydrotestosterone on Day 56 at 46 mg dose	Dihydrotestosterone on Day 56 at 69 mg dose	Dihydrotestosterone on Day 90 at 23 mg dose	Dihydrotestosterone on Day 90 at 46 mg dose	Dihydrotestosterone on Day 90 at 69 mg dose
Testosterone Gel (FE 999303)	194	203	216	175	262	261	191	277	229	30.7	41.0	43.9	33.2	58.0	52.9	45.1	62.5	53.1

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Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone

Intervention	ng/dL (Mean)
	Total testosterone on Day 14 at 23 mg dose	Total testosterone on Day 35 at 23 mg dose	Total testosterone on Day 35 at 46 mg dose	Total testosterone on Day 56 at 23 mg dose	Total testosterone on Day 56 at 46 mg dose	Total testosterone on Day 56 at 69 mg dose	Total testosterone on Day 90 at 23 mg dose	Total testosterone on Day 90 at 46 mg dose	Total testosterone on Day 90 at 69 mg dose	Dihydrotestosterone on Day 14 at 23 mg dose	Dihydrotestosterone on Day 35 at 23 mg dose	Dihydrotestosterone on Day 35 at 46 mg dose	Dihydrotestosterone on Day 56 at 23 mg dose	Dihydrotestosterone on Day 56 at 46 mg dose	Dihydrotestosterone on Day 56 at 69 mg dose	Dihydrotestosterone on Day 90 at 23 mg dose	Dihydrotestosterone on Day 90 at 46 mg dose	Dihydrotestosterone on Day 90 at 69 mg dose
Testosterone Gel (FE 999303)	435	642	732	637	890	987	721	1228	1099	56.5	79.2	91.5	68.6	113	106	91.4	138	118

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Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone

A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone. (NCT02149264)
Timeframe: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90

Intervention	ng/dL (Mean)
	Total testosterone on Day 14 at 23 mg dose	Total testosterone on Day 35 at 23 mg dose	Total testosterone on Day 35 at 46 mg dose	Total testosterone on Day 56 at 23 mg dose	Total testosterone on Day 56 at 46 mg dose	Total testosterone on Day 56 at 69 mg dose	Total testosterone on Day 90 at 23 mg dose	Total testosterone on Day 90 at 46 mg dose	Total testosterone on Day 90 at 69 mg dose	Dihydrotestosterone on Day 14 at 23 mg dose	Dihydrotestosterone on Day 35 at 23 mg dose	Dihydrotestosterone on Day 35 at 46 mg dose	Dihydrotestosterone on Day 56 at 23 mg dose	Dihydrotestosterone on Day 56 at 46 mg dose	Dihydrotestosterone on Day 56 at 69 mg dose	Dihydrotestosterone on Day 90 at 23 mg dose	Dihydrotestosterone on Day 90 at 46 mg dose	Dihydrotestosterone on Day 90 at 69 mg dose
Testosterone Gel (FE 999303)	268	359	361	278	429	464	368	506	438	40.9	56.3	63.1	44.2	78.7	75.2	65.9	91.2	77.7

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Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone

Intervention	ng*hr/dL (Mean)
	Total testosterone on Day 14 at 23 mg dose	Total testosterone on Day 35 at 23 mg dose	Total testosterone on Day 35 at 46 mg dose	Total testosterone on Day 56 at 23 mg dose	Total testosterone on Day 56 at 46 mg dose	Total testosterone on Day 56 at 69 mg dose	Total testosterone on Day 90 at 23 mg dose	Total testosterone on Day 90 at 46 mg dose	Total testosterone on Day 90 at 69 mg dose	Dihydrotestosterone on Day 14 at 23 mg dose	Dihydrotestosterone on Day 35 at 23 mg dose	Dihydrotestosterone on Day 35 at 46 mg dose	Dihydrotestosterone on Day 56 at 23 mg dose	Dihydrotestosterone on Day 56 at 46 mg dose	Dihydrotestosterone on Day 56 at 69 mg dose	Dihydrotestosterone on Day 90 at 23 mg dose	Dihydrotestosterone on Day 90 at 46 mg dose	Dihydrotestosterone on Day 90 at 69 mg dose
Testosterone Gel (FE 999303)	6431	8552	8665	6624	10320	11152	8831	12245	10590	980	1343	1515	1057	1893	1811	1579	2210	1876

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Change From Baseline in Short Form-12 Health Survey (SF-12) Score

"Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains:~PCS:~Physical Functioning (2 items, questions 2-3)~Role-Physical (2 items, questions 4-5)~Bodily Pain (1 item, question 8)~General Health (1 item, question 1)~MCS:~Vitality (1 item, question 10)~Social Functioning (1 item, question 12)~Role-Emotional (2 items, questions 6-7)~Mental Health (2 items, questions 9 and 11)~PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health." (NCT02149264)
Timeframe: At Days 35 and 90

Intervention	units on a scale (Mean)
	PCS Day 35	PCS Day 90	MCS Day 35	MCS Day 90
Testosterone Gel (FE 999303)	1.2	1.8	6.3	6.5

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Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score

"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain (categorical in nature) are scored from 1-4. The scores are converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue)." (NCT02149264)
Timeframe: At Days 35 and 90

Intervention	units on a scale (Mean)
	Severity domain score at Day 35	Distress domain score at Day 35	Degree of interference domain score at Day 35	Timing domain score at Day 35	GFI score at Day 35	Severity domain score at Day 90	Distress domain score at Day 90	Degree of interference domain score at Day 90	Timing domain score at Day 90	GFI score at Day 90
Testosterone Gel (FE 999303)	-3.6	-1.7	-13.6	-2.6	-8.3	-5.2	-2.2	-16.7	-3.0	-12.0

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The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL

The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%. (NCT02149264)
Timeframe: At Day 90

Intervention	percentage of subjects (Number)
Testosterone Gel (FE 999303)	76.1

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Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)

The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism. (NCT02159469)
Timeframe: 12 weeks

Intervention	Participants (Count of Participants)
Testosterone Enanthate Auto-injector	139

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Safety and Tolerability

"Incidence of adverse events throughout the study~Incidence and severity of injection site reactions throughout the study" (NCT02159469)
Timeframe: 52 weeks

Intervention	Participants (Count of Participants)
	Patients with any TEAE	Patients with any TEAE related to IP	Patients with any SAE	Patients with TEAE leading to discontinuation	Patients discontinued due to IP related TEAE	Patients with any adverse event leading to death
Testosterone Enanthate Auto-injector	125	66	3	30	1	1

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Percentage of Responders

Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL. (NCT02222558)
Timeframe: Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24

Intervention	percentage of subjects (Number)
Period 1: Single Dose	67
Period 2: Two Times Daily Dosing 90 mg	57
Period 3: Two Times Daily Dosing 120 mg	50
Period 3: Three Times Daily Dosing 90 mg	100
Period 3: Two Times Daily Dosing 180 mg	25
Period 3: Three Times Daily Dosing 120 mg	57.1

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Time to Maximum Concentration (Tmax)(hr)

tmax = Time to reach maximum concentration (NCT02233751)
Timeframe: The sample time of Cmax during a 168 hour sampling interval

Intervention	hours (Mean)
	TT	TE
Testosterone Enanthate 200 mg	19.00	74.00
Testosterone Enanthate 50 mg	40.51	82.01

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Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate

Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate (NCT02233751)
Timeframe: Maximum serum concentrations occurring during an 8 days study window

Intervention	ng/dL (Mean)
	Serum testosterone	Serum testosterone enanthate
Testosterone Enanthate 200 mg	1487.0	267.33
Testosterone Enanthate 50 mg	773.7	49.25

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Half-life (t 1/2)(hr)

t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value (NCT02233751)
Timeframe: 168 hours

Intervention	hours (Mean)
	TT	TE
Testosterone Enanthate 200 mg	131.75	133.00
Testosterone Enanthate 50 mg	261.73	NA

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Clearance CL/F (L/hr)

Clearance - volume of plasma from which TT/TE is completely removed per unit time (NCT02233751)
Timeframe: 168 hours

Intervention	L/hr (Mean)
	TT	TE
Testosterone Enanthate 200 mg	60.46	352.84
Testosterone Enanthate 50 mg	18.07	NA

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Vd/F (L)

Vd/F (L) = Apparent volume of distribution (NCT02233751)
Timeframe: 168 hours

Intervention	Liters (Mean)
	TT	TE
Testosterone Enanthate 200 mg	10959.5	62366.4
Testosterone Enanthate 50 mg	6655.8	NA

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Area Under the Concentration-time Curve From Time Zero to Infinity

AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity (NCT02233751)
Timeframe: time zero to infinity

Intervention	(ng⋅hr/dL) (Mean)
	TT	TE
Testosterone Enanthate 200 mg	362627.4	62497.5
Testosterone Enanthate 50 mg	279062.2	NA

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Area Under the Concentration-time Curve From Time Zero to Time t

AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week); (NCT02233751)
Timeframe: 168 hrs

Intervention	(ng⋅hr/dL) (Mean)
	TT	TE
Testosterone Enanthate 200 mg	176112.8	33535.5
Testosterone Enanthate 50 mg	103731.5	6122.2

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Percent Change in Visceral Fat

Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA) (NCT02248701)
Timeframe: Baseline, 6 months, 12 months

Intervention	percent change (Mean)
	6 months	12 months
Placebo Treatment	-3.2	0.2
Testosterone Enanthate, Finasteride	-8.2	-13.6

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Percent Changes in Muscle Cross-Sectional Area

Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI (NCT02248701)
Timeframe: Baseline, 6 months, 12 months

Intervention	percent change (Mean)
	6 months	12 months
Placebo Treatment	-0.9	-1.9
Testosterone Enanthate, Finasteride	7.9	11.4

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Percent Change in Total Body Fat

Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA) (NCT02248701)
Timeframe: Baseline, 6 months, 12 months

Intervention	percent change (Mean)
	6 months	12 months
Placebo Treatment	-4.7	-1.9
Testosterone Enanthate, Finasteride	-6.8	-8.7

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Percent Change in Neuromuscular Function

Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry (NCT02248701)
Timeframe: Baseline, 6 months, 12 months

Intervention	percent change (Mean)
	6 months	12 months
Placebo Treatment	-8.6	0.5
Testosterone Enanthate, Finasteride	19.9	15.5

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Percent Change in Hip Bone Mineral Density

Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA) (NCT02248701)
Timeframe: Baseline, 6 months, 12 months

Intervention	percent change (Mean)
	Change at 6 months	Change at 12 months
Placebo Treatment	-0.5	1.1
Testosterone Enanthate, Finasteride	1.7	1.2

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Absolute Change in Walking Speed

Absolute change in 10 m walking speed (NCT02248701)
Timeframe: Baseline, 6 months, 12 months

Intervention	meters/second (m/s) change (Mean)
	6 months	12 months
Placebo Treatment	0.05	0.01
Testosterone Enanthate, Finasteride	0	0.10

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Quality of Life as Assessed by FACIT Fatigue Scale

The Functional Assessment of Chronic Illness Therapy - Fatigue has a score range of 0-52 with higher scores indicating better quality of life. (NCT02286921)
Timeframe: up to 1 year

Intervention	score on a scale (Mean)
	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	38.13	38.39	39.23	41.67
Arm B: Enzalutamide	32.60	33.51	34.51	34.58

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Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression

"Time to clinical progression will be defined as months from randomization to any of the following (whichever occurs earlier):~Cancer pain requiring initiation of chronic administration of opiate analgesia (oral opiate use for ≥3 weeks; parenteral opiate use for ≥7 days. Patients with cancer pain requiring opiate analgesia for relief should also be assessed by the investigator for the need for initiating systemic chemotherapy or palliative radiation.~Development of a skeletal-related event (SRE): pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone.~Development of clinically significant symptoms due to loco-regional tumor progression (e.g. urinary obstruction) requiring surgical intervention or radiation therapy." (NCT02286921)
Timeframe: up to 2 years

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	5.62
Arm B: Enzalutamide	5.72

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Progression Free Survival on Crossover Treatment

Time from initiation of therapy to progression on crossover treatment (NCT02286921)
Timeframe: up to 2 years

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	28.2
Arm B: Enzalutamide	19.6

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Prostate-Specific Antigen Response Rate

Number of participants achieving a Prostate-Specific Antigen decline ≥ 50% according to Prostate Cancer Working Group (PCWG2) criteria. (NCT02286921)
Timeframe: Up to 2 years

Intervention	Participants (Count of Participants)
Arm A: Testosterone Cypionate or Testosterone Enanthate	14
Arm B: Enzalutamide	18

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Radiographic Progression

Number of months until 20% increase in the sum of target lesions on CT scans. (NCT02286921)
Timeframe: up to 2 years

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	5.75
Arm B: Enzalutamide	8.28

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Time to Prostate-Specific Antigen Progression

Reported as number of months till Prostate-Specific Antigen increase of greater or equal to 50% according to Prostate Cancer Working Group (PCWG2) criteria. (NCT02286921)
Timeframe: Up to 2 years

Intervention	month (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	2.79
Arm B: Enzalutamide	3.81

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Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)

The Positive Affect Score is calculated by adding the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. (NCT02286921)
Timeframe: up to 1 year

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	33.99	33.72	33.23	33.96	36.24
Arm B: Enzalutamide	32.35	32.33	31.48	31.84	29.88

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Objective Response Rate as Determined by RECIST

Number of participants with partial (PR) or complete response (CR) as defined by response evaluation criteria in solid tumors (RECIST), where CR is a disappearance of all target lesions and PR is ≥30% reduction in the sum of the longest diameter of target lesions. (NCT02286921)
Timeframe: Up to 2 years

Intervention	Participants (Count of Participants)
Arm A: Testosterone Cypionate or Testosterone Enanthate	8
Arm B: Enzalutamide	1

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Overall Survival

Time until death for any reasons (NCT02286921)
Timeframe: up to 3 years

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	32.9
Arm B: Enzalutamide	29

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Quality of Life as Assessed by Short Form 36

All questions are scored on a scale from 0 to 100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100 with 100 representing the highest level of functioning possible. (NCT02286921)
Timeframe: up to 1 year

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	63.16	61.68	62.34	63.49	67.35
Arm B: Enzalutamide	61.89	56.94	55.34	58.67	59.65

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Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire

The IIEF assesses erectile function (EF), orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS), orgasmic satisfaction (OS). Each of domains are scored on a scale of 0 to 5 with a lower score indicating a bad quality sex life. The IIEF questionnaire has a total score that ranges from 5 to 25 with lower score indicating less erectile dysfunction. A positive change in the score reflects better outcome. (NCT02286921)
Timeframe: up to 1 year

Intervention	score on a scale (Mean)
	EF - baseline to month 1	EF - baseline to month 3	EF - baseline to month 6	EF - baseline to month 12	OF - baseline to month 1	OF - baseline to month 3	OF - baseline to month 6	OF - baseline to month 12	SD - baseline to month 1	SD - baseline to month 3	SD - baseline to month 6	SD - baseline to month 12	IS - baseline to month 1	IS - baseline to month 3	IS - baseline to month 6	IS - baseline to month 12	OS - baseline to month 1	OS - baseline to month 3	OS - baseline to month 6	OS - baseline to month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	1.17	2.65	2.36	2.5	0.91	1.93	2.19	2.93	0.97	1.85	2.52	2.38	0.36	1.55	0.74	2.40	0.65	1.13	0.60	2.00
Arm B: Enzalutamide	0.09	0.05	0.65	0.05	0.25	-0.02	0.04	0.17	-0.27	0.10	0.18	0.30	-0.01	0.05	0.08	0.00	0.17	0.25	-0.09	0.20

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Pain Interference as Assessed by the Brief Pain Inventory

Interference is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10, higher score indicates more pain interference. (NCT02286921)
Timeframe: 1 year

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	1.22	1.55	2.00	1.96	1.04
Arm B: Enzalutamide	1.27	2.26	1.94	1.84	1.70

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Pain Severity as Assessed by the Brief Pain Inventory

Severity is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10, high score indicates more severe pain. (NCT02286921)
Timeframe: 1 year

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	1.29	1.19	1.67	1.57	0.76
Arm B: Enzalutamide	1.20	1.94	1.62	1.81	1.13

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Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)

The Negative Affect Score is calculated by adding the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. (NCT02286921)
Timeframe: up to 1 year

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	13.89	14.28	14.44	14.26	14.24
Arm B: Enzalutamide	13.96	14.90	15.43	14.80	13.48

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Change in Static Balance

assessed by one leg limb stance (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	seconds (Mean)
Placebo + Lifestyle Therapy	4.5
Testosterone + Lifestyle Therapy	5.0

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Change in Symbol Digital Modalities Test

"Assesses key neurocognitive functions that underlie many substitution tasks, including attention, visual scanning, and motor speed.~Minimum score is 0, there is no maximum value. Higher scores indicate better outcome." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo + Lifestyle Therapy	1.1
Testosterone + Lifestyle Therapy	2.8

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Change in the Physical Performance Test

The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 50 ft, putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36. Higher scores indicate better physical function. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo + Lifestyle Therapy	4.6
Testosterone + Lifestyle Therapy	4.9

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Change in Thigh Muscle Volume

Assessed by using magnetic resonance imaging (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	cm^3 (Mean)
Placebo Plus Lifestyle Therapy	-68
Testosterone Plus Lifestyle Therapy	-25

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Change in Total Hip Bone Mineral Density

Assessed by using dual-energy x-ray absorptiometry (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	gm/cm^2 (Mean)
Placebo Plus Lifestyle Therapy	-0.013
Testosterone Plus Lifestyle Therapy	0.007

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Change in Total Testosterone Levels

as measured in the peripheral blood by liquid chromatography/mass spectrometry (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	ng/dL (Mean)
Placebo Plus Lifestyle Therapy	60
Testosterone Plus Lifestyle Therapy	306

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Change in Trabecular Bone Score (Trabecular Bone Quality)

"assessed by trabecular bone score (TBS), a newly developed index for assessing trabecular bone quality and fracture risk.~TBS is a bone texture parameter that quantifies cancellous bone microachitecture, which is key in determining bone strength and resistance to fracture, by computing raw data from dual energy x-ray absorptiometry of the lumbar spine.~There are no minimum or maximum values. Higher scores mean better outcome." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Least Squares Mean)
Testosterone + Lifestyle Therapy	0.11
Placebo + Lifestyle Therapy	0.12

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Change in Trail A

"Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a greater focus on attention).~Minimum score is 0, there is no maximum value. Higher scores indicate better outcome." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	-7.7
Testosterone Plus Lifestyle Therapy	-13.9

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Change in Trail B

"Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a focus on executive function)~Minimum score is 0, there is no maximum value. Higher scores indicate better outcome." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	-10.2
Testosterone Plus Lifestyle Therapy	-19.5

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Change in Triglyceride Levels

Blood samples obtained in the fasting state as part of measurements of lipid profile (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	mg/dl (Mean)
Placebo + Lifestyle Therapy	-39
Testosterone + Lifestyle Therapy	-31

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Change in Waist Circumference

Waist circumference as measured horizontally at the midpoint between the highest point of the iliac crest and the lowest portion of the 12th rib in the standing position. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	cm (Mean)
Placebo Plus Lifestyle Therapy	-9.4
Testosterone Plus Lifestyle Therapy	-8.4

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Change in Word List Fluency

Measure of verbal production, semantic memory, and language. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	0.2
Testosterone Plus Lifestyle Therapy	0.9

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Stroop Interference

"Assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.~Minimum score is 0, there is no maximum value. Higher scores indicate better outcome." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	score on a scale (Mean)
Placebo Plus Lifestyle Therapy	4.6
Testosterone Plus Lifestyle Therapy	3.1

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Thigh Fat Volume

Volume of fat in the thigh by measured by magnetic resonance imaging (NCT02367105)
Timeframe: 6 months

Intervention	cm^3 (Mean)
Placebo Plus Lifestyle Therapy	-292
Testosterone Plus Lifestyle Therapy	-262

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Number of Participants With Significant Changes in Functional Connectivity in the Default Mode Network

Functional connectivity was measured with seeds of the DMN (medial prefrontal cortex [MPFC] and posterior cingulate cortex [PCC]). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p<.001 at the voxel level and p<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	Participants (Count of Participants)
	DMN (MPFC seed)	DMN (PCC seed)
Placebo + Lifestyle Therapy	0	0
Testosterone + Lifestyle Therapy	0	0

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Change in Trabecular Bone Score

"The trabecular bone score is a measure of bone texture correlated with bone microarchitecture and a marker for the risk of osteoporosis.~Minimum score is 0, there is no maximum value. Higher scores indicate better bone microarchitecture." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	0.12
Testosterone Plus Lifestyle Therapy	.11

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Change in Body Weight

Measured after an overnight fast using calibrated scales (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	kilograms (Mean)
Placebo Plus Lifestyle Therapy	-10.6
Testosterone Plus Lifestyle Therapy	-9.8

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Change in C-terminal Telopeptide

biochemical marker of bone turnover (bone resorption) as measured by immunoassay technique (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	µg/L (Mean)
Placebo + Lifestyle Therapy	0.530
Testosterone + Lifestyle Therapy	0.002

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Change in Composite Cognitive Z-score

"Test of overall cognitive performance formed by averaging the standardized scores for several domains of cognitive function (attention, memory, executive, language, global). Higher scores indicate better cognitive status.~The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of the baseline scores (units on a scale). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population" (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	z-score (Mean)
Placebo Plus Lifestyle Therapy	.273
Testosterone Plus Lifestyle Therapy	.557

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Change in Dynamic Balance

Assessed by using the obstacle course (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	seconds (Mean)
Testosterone Plus Lifestyle Therapy	-2.9
Placebo Plus Lifestyle Therapy	-3.2

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Change in Endurance Capacity

Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	ml/kg/min (Mean)
Placebo Plus Lifestyle Therapy	2.8
Testosterone Plus Lifestyle Therapy	4.0

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Change in Estradiol

As measured by LC-MS/MS (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	pg/dL (Mean)
Testosterone + Lifestyle Therapy	-3.0
Placebo + Lifestyle Therapy	22.1

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Change in Fat Mass

Assessed by using dual-energy x-ray absorptiometry (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	kg (Mean)
Placebo Plus Lifestyle Therapy	-8.2
Testosterone Plus Lifestyle Therapy	-8.0

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Change in Functional Status

"Assessed by the Functional Status Questionnaire. Score range: 0 to 36 with higher scores indicating better functional status~Provides information of the participants ability to perform activities of daily living." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	2.9
Testosterone Plus Lifestyle Therapy	3.1

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Change in Gait Speed

Determined by measuring the time needed to walk 25 ft. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	m/min (Mean)
Placebo Plus Lifestyle Therapy	8.6
Testosterone Plus Lifestyle Therapy	8.2

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Change in Glucose

Measured in the blood after overnight fast (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	mg/dl (Mean)
Placebo Plus Lifestyle Therapy	-22.5
Testosterone Plus Lifestyle Therapy	-17.1

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Change in HDL-cholesterol

Blood samples obtained in the fasting state as part of measurements of lipid profile (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	mg/dl (Mean)
Placebo + Lifestyle Therapy	5.4
Testosterone + Lifestyle Therapy	0.2

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Change in Hematocrit

the ratio of the volume of red blood cells to the total volume of blood. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	percentage of red blood cells (Mean)
Placebo Plus Lifestyle Therapy	-0.5
Testosterone Plus Lifestyle Therapy	2.4

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Change in High-sensitivity C-reactive Protein (Inflammatory Marker)

measured in the peripheral blood using immunoassay technique methodology (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	mg/dl (Mean)
Placebo + Lifestyle Therapy	.19
Testosterone + Lifestyle Therapy	.18

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Change in Insulin Growth Factor-1

Measured by immunoassay methodology (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	ng/mL (Mean)
Placebo + Lifestyle Therapy	11.8
Testosterone + Lifestyle Therapy	16.9

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Change in Interleukin-6

Measured from fasting serum using immunoassay technique as marker of inflammation (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	pg/mL (Mean)
Placebo + Lifestyle Therapy	-1.1
Testosterone + Lifestyle Therapy	-1.0

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Change in International Prostate Symptom Score

Using the International Prostate Symptom Scoring (IPS); Minimum score is 0, Maximum score is 35. Higher scores mean worse outcome. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo + Lifestyle Therapy	-0.2
Testosterone + Lifestyle Therapy	-0.1

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Change in Lean Body Mass

Assessed by using dual-energy x-ray absorptiometry (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	kg (Mean)
Placebo Plus Lifestyle Therapy	-2.4
Testosterone Plus Lifestyle Therapy	-1.2

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Change in Levels of 25-hydroxyvitamin D

assessed by using immunoassay methodology (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	ng/mL (Mean)
Placebo + Lifestyle Therapy	6.2
Testosterone + Lifestyle Therapy	8.3

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Change in Lumbar Spine Bone Mineral Density

As measured by Dual energy x-ray absorptiometry (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	gm/cm^2 (Mean)
Placebo Plus Lifestyle Therapy	0.004
Testosterone Plus Lifestyle Therapy	0.007

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Change in Modified Mini-mental Exam

Test of global cognition with components for orientation, registration, attention, language, praxis, and immediate and delayed memory. Score ranges from 0 to 100 with higher scores indicate better cognition. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	1.2
Testosterone Plus Lifestyle Therapy	2.1

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Change in Mood

Using Yesavage Depression Scale Lower scores indicate better mood (range 0 to 30). (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	score on a scale (Mean)
Placebo + Lifestyle Therapy	-1.43
Testosterone + Lifestyle Therapy	-1.39

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Change in Muscle Strength

assessed by total1-repetition maximum (the maximal weight lifted at one time; the totals are the sum of the maximal weights lifted in the biceps curl, bench press, 387 seated row, knee extension, knee flexion, and leg press exercises). (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	kg (Mean)
Placebo Plus Lifestyle Therapy	72
Testosterone Plus Lifestyle Therapy	68

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Change in N-terminal Propeptide of Type I Procollagen

Biochemical marker of bone turnover (bone formation) as measured by radioimmunoassay technique (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	µg/L (Mean)
Placebo + Lifestyle Therapy	-4.7
Testosterone + Lifestyle Therapy	1.5

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Change in Parathyroid Hormone Level

Measured by immunoassay methodology as marker of bone metabolism (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	pg/mL (Mean)
Placebo + Lifestyle Therapy	12.9
Testosterone + Lifestyle Therapy	9.0

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Change in Peripheral Quantitative Computed Tomography Measures (Volumetric Bone Density)

assessed by quantitative computed tomography at 4% distal tibia using the following thresholds: 180 mg/cm3 and 45% of the area (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	mg/cm^3 (Mean)
Placebo + Lifestyle Therapy	-3.1
Testosterone + Lifestyle Therapy	-0.3

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Change in Prostate Specific Antigen

blood test to screen for prostate cancer (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	ng/mL (Mean)
Placebo Plus Lifestyle Therapy	0.2
Testosterone Plus Lifestyle Therapy	0.5

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Change in Ray Auditory Verbal Learning Test

"The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information.~Minimum score is 0, there is no maximum value. Higher scores indicate better outcome." (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	3.1
Testosterone Plus Lifestyle Therapy	7.0

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Change in Short Form Health Survey (SF-36) Quality of Life Physical Component

Using Short Form-36 of Life Questionnaire Physical Component subscale. Minimum score is 0, Maximum score is 100. Higher scores indicate better outcome. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	units on a scale (Mean)
Placebo Plus Lifestyle Therapy	5.5
Testosterone Plus Lifestyle Therapy	7.1

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Change in Skeletal Muscle Growth Factor (MYOD1)

Assessed by using RNA-seq quantification of gene expression in skeletal muscles obtained during muscle biopsies. (NCT02367105)
Timeframe: Baseline and 6 months

Intervention	log2fold (Mean)
Placebo Plus Lifestyle Therapy	0.23
Testosterone Plus Lifestyle Therapy	0.53

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Serum Follicle Stimulating Hormone (FSH)

Serum will be collected at the first study visit prior to randomization. Ultrasensitive FSH will be measured. (NCT02408445)
Timeframe: baseline only

Intervention	mIU/mL (Mean)
Testosterone Treatment	1.8
No Treatment	1.7

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Serum Total Testosterone

Serum will be collected at the first study visit prior to randomization. Total testosterone by mass spectroscopy will be measured. (NCT02408445)
Timeframe: baseline only

Intervention	ng/dl (Mean)
Testosterone Treatment	181
No Treatment	166

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Serum Luteinizing Hormone (LH)

Serum will be collected at the first study visit prior to randomization. Ultrasensitive LH will be measured. (NCT02408445)
Timeframe: baseline only

Intervention	mIU/mL (Mean)
Testosterone Treatment	2.5
No Treatment	2.5

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Serum Inhibin B (INHB)

Serum will be collected at the first study visit prior to randomization. Inhibin B levels will be measured. (NCT02408445)
Timeframe: baseline only

Intervention	pg/ml (Mean)
Testosterone Treatment	244
No Treatment	355

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Serum Anti-Mullerian Hormone (AMH)

Serum will be collected at the first study visit prior to randomization. AMH levels will be measured. (NCT02408445)
Timeframe: baseline only

Intervention	pmol/l (Mean)
Testosterone Treatment	1377
No Treatment	2208

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Change in Total Motor Standard Score on the Peabody Developmental Motor Scales 2

Motor development will be assessed by an occupational therapist using the standardized Peabody Developmental Motor Scales 2. Standard scores are normalized to age with a mean of 100 and standard deviation of 15. Change in standard score was calculated as the differences between the subject's standard score at 3 months minus the standard score at baseline. A positive change in standard scores would indicate greater growth on the measure relative to peers, while a negative number would indicate slower growth on the measure relative to peers. (NCT02408445)
Timeframe: 3 months

Intervention	change in standard score (Mean)
Testosterone Treatment	2.8
No Treatment	2.0

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Change in Raw Score on the Alberta Infant Motor Scale

Muscle tone and motor development will be assessed by an occupational therapist using the standardized Alberta Infant Motor Scale (AIMS). The AIMS scale measures infant motor maturation from birth until the age of independent walking. An occupational therapists assesses 58 motor behavior items in 4 position categories: prone (21 items), supine (9 items), sitting (12 items) & standing(16 standing). Each item receives one point (range of raw scores 0-58), with higher scores indicating more skills acquired. For change in scores, the raw score at 3 months was subtracted from the baseline raw score. (NCT02408445)
Timeframe: 3 months

Intervention	raw score (Mean)
Testosterone Treatment	10.5
No Treatment	8.9

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Change in Penile Length

Stretched penile length will be measured by a physician before randomization and at the end of the study period. (NCT02408445)
Timeframe: Baseline and 3 months

Intervention	cm (Mean)
Testosterone Treatment	0.9
No Treatment	-0.3

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Change in Fat Free Mass

Fat free mass (lean mass) will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period. (NCT02408445)
Timeframe: Baseline and 3 months

Intervention	kg (Mean)
Testosterone Treatment	1.4
No Treatment	0.6

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Change in Body Fat Percent Z-score

Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period. Age and sex-normed z-scores will be calculated. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Change in the z-score over time, if following a normal growth curve, is 0. Positive change in z-scores indicates a gain in body fat above growth typically expected. Negative change in z-scores indicates a gain in body fat that is less than typically expected. (NCT02408445)
Timeframe: Baseline and 3 months

Intervention	score on a scale (Mean)
Testosterone Treatment	-0.12
No Treatment	0.92

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Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism

"Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population.~Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)" (NCT02504541)
Timeframe: 26 weeks

Intervention	Participants (Count of Participants)
	Patients with any TEAE	Patients with any TEAE related to QST	Patients with SAE	Patients with TEAE leading to Discontinuation	Patients with QST related TEAE and discontinuation
Testosterone Enanthate Auto-injector	87	34	4	8	4

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Area Under the QTF Versus Time Curve for 0-1 Hour Following Ibutilide 0.003 mg/kg

"Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. Three 12-lead ECGs were obtained ~ 1 minute apart immediately at the end of the ibutilide infusion and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours post-infusion. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers. QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. Area under the QTF curve was calculated using the trapezoidal rule and reflects overall QTF interval exposure over time." (NCT02513940)
Timeframe: 1 hour following ibutilide administration

Intervention	ms·hr (Mean)
Testosterone	471
Progesterone	480
Placebo	483

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Maximum QTF Following Ibutilide 0.003 mg/kg

QT interval is an ECG measure of ventricular repolarization. Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. Three 12-lead ECGs were obtained ~ 1 minute apart immediately at the end of the ibutilide infusion and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours post-infusion. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers. QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. QT intervals vary with heart rate, and therefore must be corrected for heart rate. QT intervals were corrected using the Fridericia (QTF) method. Maximum QTF is the longest QTF measured following ibutilide at any time point. (NCT02513940)
Timeframe: Within 8 hours following ibutilide administration

Intervention	ms (Mean)
Testosterone	416
Progesterone	425
Placebo	426

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Number of Participants With Adverse Effects Associated With Testosterone, Progesterone and Placebo

Adverse effects were assessed by study investigators using telephone calls during the 7-day treatment period in each phase, as well as by asking participants about adverse effects on ibutilide administration days (NCT02513940)
Timeframe: During 7 day administration periods

Intervention	Participants (Count of Participants)
	Fatigue	Rash on gel application site
Placebo	0	1
Progesterone	1	0
Testosterone	0	0

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Baseline (Pre-ibutilide) Individualized Rate-corrected QT Interval (QTF)

QT interval is an electrocardiogram (ECG) measure of ventricular repolarization. Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers (EP Calipers 1.6). QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. Only clearly discernable QT intervals were measured. QT intervals vary with heart rate, and therefore must be corrected for heart rate. QT intervals were corrected using the Fridericia (QTF) method. The baseline QTF assesses the influence of testosterone and progesterone on naturally-occurring (before ibutilide administration) QTF (NCT02513940)
Timeframe: Following 7 days of testosterone, progesterone or placebo

Intervention	ms (Mean)
Testosterone	393
Progesterone	399
Placebo	399

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Maximum Percent Change From Pretreatment Value in QTF Following Ibutilide 0.003 mg/kg

QT interval is an ECG measure of ventricular repolarization. Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. Three 12-lead ECGs were obtained ~ 1 minute apart immediately at the end of the ibutilide infusion and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours post-infusion. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers. QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. QT intervals were corrected using the Fridericia (QTF) method. (NCT02513940)
Timeframe: Within 8 hours of ibutilide administration

Intervention	Percent change (Mean)
Testosterone	5.6
Progesterone	5.9
Placebo	6.1

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Testosterone Level in Blood as Measured for Safety

Testosterone level in blood to ensure safety levels of testosterone prior to (Day 0) and after the first two weeks of drug administration (Day 19). Steroid levels below the normal range were considered safe to continue study participation. (NCT02611154)
Timeframe: Day 0 and Day 19

Intervention	ng/mL (Mean)
Serum Testosterone - Day 0	408.4
Serum Testosterone - Day 19	373.4

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Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline

"Participants were asked to provide 3 urine samples at Day 1, Day 3, Day 5 to measure their baseline urinary steroid marker levels. To accommodate participant schedules, all baseline samples were collected within a two week timeframe. This outcome is measuring if any participants baseline urine samples resulted in a suspicious steroid profile. For this study, suspicious is defined as any urine sample resulting in testosterone steroid detection above 200ng/mL." (NCT02611154)
Timeframe: Day 1, Day 3, Day 5

Intervention	Participants (Count of Participants)
Testosterone	0
Epitestosterone	0
Androsterone	0
Etiocholanolone	0
5αAdiol	0
5βAdiol	0

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Steroid Levels in Urine Steroid Profile

"Participants were instructed to follow this dosing pattern:~Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28~The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29.~Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose" (NCT02611154)
Timeframe: 4 weeks of dosing for each participant

,,,,,,,

Intervention	ng/mL (Mean)
	Testosterone	Epitestosterone	Androsterone	Etiocholanolone	5αAdiol	5βAdiol
Urine Steroid Profile - Day 13	138.0291641	16.23444899	3147.357191	2984.088377	70.09892435	370.2752839
Urine Steroid Profile - Day 21	163.117081	10.08654906	3377.718911	3168.249168	79.92660959	386.6496467
Urine Steroid Profile - Day 28	107.7160658	9.736167767	4014.439418	4614.568182	83.39693284	369.209311
Urine Steroid Profile - Day 29	14.15587072	12.22899541	1098.544542	1154.779419	37.53345262	145.5896139
Urine Steroid Profile - Day 30	21.42280994	16.38534782	1689.228939	1810.282342	51.7003489	158.5303528
Urine Steroid Profile - Day 35	32.9077285	27.76476978	2292.971167	2612.685992	60.19484767	166.0185686
Urine Steroid Profile - Day 42	28.14492389	32.56796986	1561.824479	1281.752255	56.94343765	85.54384971
Urine Steroid Profile - Day 6	69.5773456	14.54132527	2780.422993	3420.811467	81.50246345	323.5235566

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% of Mean Difference in T Concentration Compared to Plain Collection Tube

"The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube.~The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab." (NCT02670343)
Timeframe: Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.

Intervention	Difference as % of Mean of T results (Mean)
	NAF+EDTA	NAF+Oxalate	NAF
Oral Testosterone Undecanoate	8.6	16.6	23.2

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Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks

During the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome. (NCT02679274)
Timeframe: 10 Weeks

Intervention	seconds (Number)
Placebo	10
Testosterone	10

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Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline

During the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome. (NCT02679274)
Timeframe: baseline

Intervention	seconds (Number)
Placebo	0
Testosterone	0

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Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks.

Intervention	seconds (Number)
Placebo	10
Testosterone	10

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Change in Knee Extension Strength (Seated)

Collected using a manual muscle tester (MMT). (NCT02679274)
Timeframe: 0 to 10 Weeks

Intervention	kg (Number)
Placebo	1.7
Testosterone	5.9

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Change in Hip Abduction Strength (Supine)

Collected using a manual muscle tester (MMT). (NCT02679274)
Timeframe: 0 to 10 Weeks

Intervention	kg (Number)
Placebo	0.9
Testosterone	2.6

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Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline

Intervention	seconds (Number)
Placebo	0
Testosterone	10

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Change in Handgrip Strength

Measured using a handgrip dynamometer (NCT02679274)
Timeframe: 0 to 10 Weeks

Intervention	kg (Number)
Placebo	-5.0
Testosterone	5.0

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Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline

During the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their faster time. (NCT02679274)
Timeframe: baseline

Intervention	seconds (Number)
Placebo	1.08
Testosterone	2.02

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Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks

Intervention	seconds (Number)
Placebo	1.08
Testosterone	1.01

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Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline

During the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome. (NCT02679274)
Timeframe: baseline

Intervention	seconds (Number)
Placebo	0
Testosterone	0

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Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks

Intervention	seconds (Number)
Placebo	0
Testosterone	2.6

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Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB).

During the gait speed section of the Short Physical Performance Battery (SPPB) subjects are timed while walking a predefined 4 meter course. Data is shown as change in speed (meters/second) from baseline (0 weeks) to 10 weeks. A increase in speed indicates a better outcome. (NCT02679274)
Timeframe: 0 to 10 Weeks

Intervention	meters/second (Number)
Placebo	0.10
Testosterone	0.48

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Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)

Fat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA). (NCT02679274)
Timeframe: 0 to 10 Weeks

Intervention	kg (Number)
Placebo	0.8
Testosterone	2.5

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Mean Serum Testosterone Cavg

The objective of the study was to determine the single day serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU formulation) administered once- and twice-daily to hypogonadal men. (NCT02697188)
Timeframe: Concentrations at -0.5, 0, 1, 2, 4, 8, 12, 13, 14, 16, 20, 24 and 34 hours post dose

Intervention	ng/dL (Mean)
	TE Period 1 400 mg QD	TU Period 2 200 mg QD	TU Period 3 100 mg BID	TU Period 4 200 mg BID	TE Period 5 400 mg BID
Testosterone Enanthate and Testosterone Undecanoate	293	246	281	385	316

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Mean Serum Dihydrotestosterone Cmax

Intervention	ng/dL (Mean)
	TE Period 1 400 mg QD	TU Period 2 200 mg QD	TU Period 3 100 mg BID	TU Period 4 200 mg BID	TE Period 5 400 mg BID
Testosterone Enanthate and Testosterone Undecanoate	140	122	97.9	114	127

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Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8

Compare the Oral TU-treated subjects and the Topical Axiron®-treated subjects with respect to number of subjects in the cosyntropin stimulation test substudy with a normal maximum post-stimulation (cosyntropin stimulation) cortisol level at Visit 8. (NCT02722278)
Timeframe: Approximately 4.5 months

Intervention	Participants (Count of Participants)
Oral TU Cosyntropin Substudy Subjects	19
Axiron Cosyntropin Substudy Subjects	8

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Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7

(NCT02722278)
Timeframe: Day 105

Intervention	Participants (Count of Participants)
Oral Testosterone Undecanoate	145
Axiron Testosterone Topical Solution	48

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Body Composition at the End of Each Study Phase

Height was measured using a stadiometer. Weight was measured using a calibrated digital scale. Body composition was determined using dual-energy X-ray absorptiometry. These data were used to calculate fat-free body mass, fat mass, and total body tissue mass. (NCT02734238)
Timeframe: end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3

Intervention	kilograms (Least Squares Mean)
	Total Body Mass at end of Phase 1	Total Body Mass at end of Phase 2	Total Body Mass at end of Phase 3	Fat-free Mass at end of Phase 1	Fat-free Mass at end of Phase 2	Fat-free Mass at end of Phase 3	Fat Mass at end of Phase 1	Fat Mass at end of Phase 2	Fat Mass at end of Phase 3
Energy Deficit	78.3	73.3	76.5	58.3	58.0	60.5	16.8	12.2	12.8
Energy Deficit + Testosterone	78.0	75.8	79.3	57.9	60.4	63.1	16.8	12.0	12.8

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Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.

Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization. (NCT02777242)
Timeframe: 3 weeks

Intervention	Participants (Count of Participants)
	Patients with any TEAE	Patients with any TEAE related to QST	Patients with SAE	Patients with TEAE leading to discontinuation	Patients with QST related TEAE and discontinuation
Testosterone Enanthate Auto-injector	5	1	0	0	0

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Cmax-am for Oral TU Across Breakfast With Varying Fat Content

Peak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content. (NCT02921386)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Intervention	ng/dL (Geometric Mean)
Breakfast A - Fasting	250.7
Breakfast B - 15 g Fat	334.7
Breakfast C - 30 g Fat	529.7
Breakfast D - 45 g Fat	506.0
Breakfast E - High Fat	463.4

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Area Under the Curve (AUC-am)

The 12 hours following morning dose area under the curve (AUC) will assessed for each sequence of breakfasts with varying fat content. (NCT02921386)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Intervention	ng*hr/dL (Geometric Mean)
Breakfast A - Fasting	1905
Breakfast B - 15 g Fat	2428
Breakfast C - 30 g Fat	3279
Breakfast D - 45 g Fat	3395
Breakfast E - High Fat	3187

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Time Weighted Average Total Testosterone Concentration (Cavg-am)

The time weighted average of total testosterone concentration will be assessed for each dosing interval. (NCT02921386)
Timeframe: 12 hours

Intervention	ng/dL (Geometric Mean)
Breakfast A - Fasting	160.0
Breakfast B - 15 g Fat	203.7
Breakfast C - 30 g Fat	275.1
Breakfast D - 45 g Fat	285.1
Breakfast E - High Fat	267.3

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Time of Peak Concentration (Tmax-am)

The time of peak concentration (Tmax-am) will be assessed within each relevant dosing interval. (NCT02921386)
Timeframe: 12 hours

Intervention	hours (Median)
Breakfast A - Fasting	4.000
Breakfast B - 15 g Fat	2.000
Breakfast C - 30 g Fat	2.000
Breakfast D - 45 g Fat	2.000
Breakfast E - High Fat	2.000

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Patient Satisfaction - Change From Baseline

The primary objective of this study is to measure patient satisfaction with testosterone replacement therapy before, during and after treatment with NATESTO. Patient satisfaction with treatment will be measured by TSQM (Treatment Satisfaction Questionnaire for Medication) Version 9, a 9-item validated instrument. TSQM domains include - Effectiveness, Convenience, Global Satisfaction. The score for each domain is converted into a scale out of 100. Higher values imply a better outcome. (NCT02937740)
Timeframe: Baseline and 3 months for BID, 4 months for TID

Intervention	Units on a scale (Mean)
	Effectiveness Domain Change from Baseline	Convenience Domain Change from Baseline	Global Satisfaction Domain Change from Baseline
Natesto Testosterone Intranasal Gel Given BID	9.6	18.9	-0.6
Natesto Testosterone Intranasal Gel Given TID	21.5	21.9	13.3

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Change in Hypogonadism Symptoms

Change in hypogonadism symptoms from baseline as measured by qADAM, a 10 point validated instrument. qADAM is a 10-item, patient-reported outcome measure used to evaluate the symptom severity of hypogonadism. Responses can range from 1 to 5 per question allowing for a minimum to maximum score range of 10 to 50. Higher values imply a better outcome. (NCT02937740)
Timeframe: Baseline and 3 months for BID, 4 months for TID

Intervention	Units on a scale (Mean)
Non-naive Patients - BID Treatment	4.8
Naive Patients - BID Treatment	12.0
Non-naive Patients - TID Treatment	3.9
Naive Patients - TID Treatment	6.8

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Change in Levels of Serum LH

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Intervention	miu/ml (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	0.4	0.3	NA	NA	NA	NA
"SQ"	NA	NA	0.2	0.04	0.1	0.4

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Change in Levels of Serum SHBG

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Intervention	nmol/l (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	25.5	22	NA	NA	NA	NA
"SQ"	NA	NA	27.8	24.8	22.9	20.7

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Change in Levels of Serum FSH

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Intervention	miu/ml (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	1.3	0.4	NA	NA	NA	NA
"SQ"	NA	NA	0.2	0.1	0.05	0.3

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Change in Levels of Serum Estradiol

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Intervention	pg/mL (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	70.03	52.00	NA	NA	NA	NA
"SQ"	NA	NA	30.06	45.12	64.74	25.99

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Change in Levels of Whole Blood Hematocrit

Blood samples measured by Quest assays and equipment. (NCT03091348)
Timeframe: "Last visit (Visit 7)"

Intervention	g/dL (Number)
"SQ"	NA
"IM"	1.9

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Change in Levels of Serum Calculated Free T Concentration

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Last visit ( Visit 7)"

Intervention	ng/dL (Number)
"SQ"	0.84
"IM"	14.74

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Change in Level of Serum PSA

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Last visit (Visit 7)"

Intervention	ng/mL (Number)
"SQ"	0.25
"IM"	0.02

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Change in Levels of Serum Total Testosterone Concentration

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

Intervention	ng/dl (Number)
	visit 2	visit 3	visit 4	vist 5	visit 6	visit 7
"IM"	1043.6	785.7	NA	NA	NA	NA
"SQ"	NA	NA	203.5	1367.9	980.8	144.7

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Mean Change in Level of FSH in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	mIU/mL (Mean)
Combination Therapy	-3.29

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Mean Change in Level of IGF-1 in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	ng/mL (Mean)
Combination Therapy	89.79

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Number of Participants Who Experienced an AE

AEs were collected through patient report, interval laboratory studies, resting echocardiograms, dual energy x-ray absorptiometry (DEXA) studies, and physical examinations. (NCT03123913)
Timeframe: 36 weeks

Intervention	Participants (Count of Participants)
Combination Therapy	14

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Mean Change in Total Lean Body Mass

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	Kg (Mean)
Combination Therapy	2.21

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Mean Change in Level of TSH in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	uIU/mL (Mean)
Combination Therapy	0.37

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Mean Change in Level of Total Testosterone in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	ng/dL (Mean)
Combination Therapy	8.26

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Mean Change in Level of Free Testosterone in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	pg/mL (Mean)
Combination Therapy	17.42

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Mean Change in Level of Luteinizing Hormone in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	mIU/mL (Mean)
Combination Therapy	-3.48

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Effect of SOV2012-F1 on Adrenal Cortical Function as Assessed by Measuring the Cortisol Response to Synthetic ACTH at Baseline in Subjects

To determine the effect of SOV2012-F1 on adrenal cortical function as assessed by measuring the cortisol response to synthetic ACTH at baseline and after 52 weeks of treatment in a subset of SOV2012-F1 subjects. . The sample size was calculated based on a assumed common Standard Deviation of 93 nmol/L to yield a half-width of not more than 60 nmol/L; hence a sample size of 30 was targeted for the investigational (SOV2012-F1) arm, and 15 for the safety control arm (AndroGel). (NCT03198728)
Timeframe: 52 weeks

Intervention	nmol/L (Mean)
	Maximum Serum Cortisol (Day 1 - Baseline)	Maximum Serum Cortisol (Day 365 - End of Study)
Andro-Gel™ Treated	25.68	27.05
SOV2012-F1-Treated	23.75	25.22

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Percentages of Participants in Each Category for Maximum Plasma Concentration

To determine the percentage of treated subjects with maximum plasma testosterone concentration (T Cmax) values (a) < 1.5X Upper Limit of Normal (ULN); (b) 1.8X to 2.5X ULN; and (c) > 2.5X ULN. For NaF/EDTA plasma, thresholds are 1200, 1440 and 2000 ng/dL of T. For serum, thresholds are 1500, 1800 and 2500 ng/dL of T. Note that the endpoint concerns only the investigational treatment SOV2012-F1 and the AndroGel results are reported for completeness. The reported percentages do not sum to 100% as the FDA criteria do not specify the percentage of subjects in the window of ≥ 1.5X and ≤ 1.8X the ULN. (NCT03198728)
Timeframe: 90 days

Intervention	percentage of actual number of subjects (Number)
	T Cmax < 1200 ng/dL for SOV2012-F1; T Cmax < 1500 ng/dL for Andro-gel after 90 days	T Cmax 1440 to 2000 ng/dL for SOV2012-F1; T Cmax 1800 to 2500 ng/dL for Andro-gel after 90 days	T Cmax > 2000 ng/dL for SOV2012-F1; T Cmax > 2500 ng/dL for Andro-gel after 90days
Andro-gel™ Treated	92.2	2.2	1.1
SOV2012-F1 Treated	76.9	7.5	3.2

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Change in Bilirubin

"Change in bilirubin from Baseline The bilirubin test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the bilirubin value." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.

Intervention	mg/dL (Mean)
	Bilirubin - Baseline	Bilirubin, Visit 8 - Day 90	Bilirubin, Visit 10 - Day 180	Bilirubin, Visit 12 - Day 270	Bilirubin, Visit Day 365	Bilirubin, End of Treatment
Andro-Gel™ Treated	0.465	-0.058	-0.004	0.029	0.038	0.026
SOV2012-F1-Treated	0.491	-0.088	-0.007	0.013	-0.027	-0.032

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Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1.

Efficacy assessment includes T Cavg calculated from NaF/EDTA plasma testosterone. The T Cavg is calculated as the 24-hour area under the curve (AUC), divided by 24, at Day 90, based on a fifteen blood samples (PK samples) taken over the 24-hours. The T concentration in each sample is measured using a validated LC-MS/MS method. The use of NaF/EDTA plasma tubes chilled after sample collection provides the most accurate values, as the prodrug TU may degrade post-sample collection, artificially inflating testosterone values. (NCT03198728)
Timeframe: 90 days

Intervention	Participants (Count of Participants)
SOV2012-F1 Treated	166

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Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel

"Changes from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), as mmHg.~The blood pressure results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the measured SBP or DBP." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.

Intervention	mmHg (Mean)
	Clinic systolic BP - Baseline	Clinic systolic BP - 90 day	Clinic systolic BP - 180 day	Clinic systolic BP - 365 day	Clinic diastolic BP - Baseline	Clinic diastolic BP - 90 day	Clinic diastolic BP - 180 day	Clinic diastolic BP - 365 day
Andro-Gel™ Treated	125.95	3.07	1.91	3.38	79.19	1.10	2.60	1.75
SOV2012-F1-Treated	125.8	2.16	1.89	2.75	78.88	0.58	0.67	1.14

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Change From Baseline in Fasting Insulin Concentration

"The measured value is the insulin concentration reported as in units of uU/mL. The insulin results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.

Intervention	uU/mL (Mean)
	Baseline	Visit 8 - Day 90	Visit 10 - Day 180	Visit 12 - Day 270	End of Treatment
Andro-Gel™ Treated	24.83	2.43	5.12	0.54	-2.58
SOV2012-F1-Treated	27.30	3.59	2.77	5.12	-5.24

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Change From Baseline in Fasting Serum Glucose (FSG) Concentration

"The measured value is the FSG concentration reported as mg/dL. The FSG results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.

Intervention	mg/dL (Mean)
	Baseline	Visit 8 - Day 90	Visit 10 - Day 180	Visit 12 - Day 270	End of Treatment
Andro-Gel™ Treated	110.3	3.0	2.4	6.2	-0.8
SOV2012-F1-Treated	108.6	4.2	1.4	1.4	-4.7

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Change From Baseline in Hematology Parameters

"Hematology parameters (HbA1c) with diabetes mellitus and Without diabetes mellitus.~The HbA1c test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The reported value at End of Treatment is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the End of Treatment value. Normal range for HbA1c is 4 to 5.6%, pre-diabetic is 5.7 to 6.4%, and diabetic is equal to or greater than 6.5%." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment

Intervention	percentage of HbA1c (Mean)
	HbA1c with diabetes mellitus (baseline)	HbA1c with diabetes mellitus end of treatment	HbA1c without diabetes mellitus (baseline)	HbA1c without diabetes mellitus end of treatment
Andro-Gel™ Treated	7.07	0.73	5.65	0.00
SOV2012-F1-Treated	7.20	0.04	5.63	0.11

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Change From Baseline in Hormone Levels

"Hormone levels (luteinizing hormone [LH], follicle-stimulating hormone [FSH], sex hormone-binding globulin [SHBG], TSH).~The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment

Intervention	mIU/mL (Mean)
	Follicle Stimulating Hormone (FSH) - Baseline	Follicle Stimulating Hormone (FSH) - Visit 8 - Day 90	Follicle Stimulating Hormone (FSH) - Visit Day 365	Follicle Stimulating Hormone (FSH) - Visit Day 365 End of Treatment	Luteinizing Hormone (LH) - Baseline	Luteinizing Hormone (LH) - Visit 8 - Day 90	Luteinizing Hormone (LH) - Visit Day 365	Luteinizing Visit Day Hormone (LH) - End of Treatment
Andro-Gel™ Treated	5.03	-3.28	-1.82	-1.77	4.58	-3.28	-1.67	-1.60
SOV2012-F1-Treated	5.46	-3.35	-2.72	-2.45	4.82	-3.25	-2.53	-2.18

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Change From Baseline in Lipid Profiles

"Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides).~The lipid test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365.~The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the lipid value." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment

Intervention	mg/dL (Mean)
	Cholesterol, Baseline	Cholesterol, Visit 8 Day 90	Cholesterol, Visit 10 Day 180	Cholesterol, Visit 12 Day 270	Cholesterol, Visit Day 365	Cholesterol, End of Treatment	HDL Cholesterol, Baseline	HDL Cholesterol, Visit 8, Day 90	HDL Cholesterol, Visit 10, Day 180	HDL Cholesterol, Visit 12, Day 270	HDL Cholesterol, Visit Day 365	HDL Cholesterol, End of Treatment	LDL Cholesterol, Baseline 1	LDL Cholesterol, Visit 8 - Day 90	LDL Cholesterol, Visit 10 - Day 180	LDL Cholesterol, Visit 12 - Day 270	LDL Cholesterol, Visit Day 365	LDL Cholesterol, End of Treatment	Triglycerides, Baseline	Triglycerides, Visit 8 - Day 90	Triglycerides, Visit 10 - Day 180	Triglycerides, Visit 12 - Day 270	Triglycerides, Visit Day 365	Triglycerides, End of Treatment
Andro-Gel™ Treated	191.1	-6.1	-5.7	-8.2	-5.5	-6.0	45.2	-1.5	-1.9	-1.6	-2.8	-2.8	108.9	-4.3	-5.4	-5.4	-5.4	-5.5	184.6	9.4	19.0	15.4	26.0	25.9
SOV2012-F1-Treated	190.5	-8.6	-10.7	-14.3	-14.0	-11.6	46.8	-7.5	-6.9	-6.7	-7.9	-7.1	110.8	-0.3	-3.1	-6.1	-4.8	-3.8	167.6	-2.5	-3.2	-8.0	-7.0	-4.8

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Change From Baseline in Liver Function Tests

"Liver function tests (ALT, AST, total bilirubin, alkaline phosphatase). The liver function test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the liver function test value" (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.

Intervention	U/L (Mean)
	Alkaline Phosphatase (Baseline)	Alkaline Phosphatase (Visit 8 - Day 90)	Alkaline Phosphatase (Visit 10 - Day 180)	Alkaline Phosphatase (Visit 12 - Day 270)	Alkaline Phosphatase (Visit Day 365)	Alkaline Phosphatase (End of Treatment)	Alanine Aminotransferase (ALT) - Baseline	Alanine Aminotransferase (ALT), Visit 8 - Day 90	Alanine Aminotransferase (ALT), Visit 10 - Day 180	Alanine Aminotransferase (ALT), Visit 12 - Day 270	Alanine Aminotransferase (ALT), Visit Day 365	Alanine Aminotransferase (ALT) - End of Treatment	Aspartate Aminotransferase (AST) - Baseline	Aspartate Aminotransferase (AST) - Visit 8, Day 90	Aspartate Aminotransferase (AST) - Visit 10, Day 180	Aspartate Aminotransferase (AST) - Visit 12, Day 270	Aspartate Aminotransferase (AST) - Visit Day 365	Aspartate Aminotransferase (AST) - End of Treatment
Andro-Gel™ Treated	74.0	-1.2	-1.6	-2.1	-1.5	-1.5	31.0	-0.0	0.9	0.7	1.3	0.9	23.4	1.2	1.7	0.3	1.2	1.0
SOV2012-F1-Treated	72.8	-6.0	-4.2	-5.5	-4.5	-4.0	30.5	-2.6	-2.9	-2.2	-1.4	-0.4	23.8	0.8	0.1	0.0	2.2	2.4

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Change From Baseline in PSA

"Serum prostate-specific antigen (PSA). The PSA results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365.~The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the PSA value." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment

Intervention	ng/mL (Mean)
	Prostate Specific Antigen, Baseline	Prostate Specific Antigen, Visit 8 - Day 90	Prostate Specific Antigen, Visit 10 - Day 180	Prostate Specific Antigen, Visit 12 - Day 270	Prostate Specific Antigen, Visit Day 365	Prostate Specific Antigen, End of Treatment
Andro-Gel™ Treated	0.78	0.18	0.22	0.29	0.27	0.41
SOV2012-F1-Treated	0.87	0.18	0.20	0.25	0.23	0.23

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Change From Baseline in the IIEF

"Patient reported outcomes are assessed by the International Index of Erectile Function (IIEF). A score of 0-5 (higher score indicating improvement) is awarded to each of the 15 questions that examine overall satisfaction (2 questions, total possible score=10), and the 4 main domains of male sexual function: erectile function (6 questions, total possible score=30), orgasmic function (2 questions, total possible score=10), sexual desire (2 questions, total possible score=10), and intercourse satisfaction (3 questions, total possible score=15).~The IIEF results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment (EOT). EOT occurred either at time of early withdrawal from the study or at Day 365.~The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and End of Treatment scores." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT)

Intervention	score on a scale (Mean)
	Erectile Function (Baseline)	Erectile Function (End of Treatment)	Intercourse Satisfaction (Baseline)	Intercourse Satisfaction (End of Treatment)	Orgasmic Function (Baseline)	Orgasmic Function (End of Treatment)	Sexual Desire (Baseline)	Sexual Desire (End of Treatment)	Overall Satisfaction (Baseline)	Overall Satisfaction Visit Day 365
Andro-Gel™ Treated	17.1	4.1	6.8	2.4	6.7	2.4	3.7	0.9	4.1	1.6
SOV2012-F1-Treated	19.8	5.1	8.4	2.4	7.3	1.5	3.6	0.7	4.8	2.3

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Change From Baseline in the IPSS

Patient reported outcomes will be assessed by the International Prostate Symptom Score (I-PSS) Reporting a score on a scale 0 to 35 (asymptomatic to very symptomatic). Mean change from baseline is reported and is the difference between the score at Baseline (pre-treatment) and at Day 90 and Day 365. Thus, a positive value at Day 90 or Day 365 represents an increase in the score from baseline. (NCT03198728)
Timeframe: Baseline (pre-treatment) to 90 days and 365 days

Intervention	score on a scale (Mean)
	Baseline	Change from baseline (Visit 8 - Day 90)	Change from baseline (Visit Day 365)
Andro-gel™ Treated	5.4	0.7	1.0
SOV2012-F1 Treated	4.4	0.2	0.6

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Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)

"Patient reported outcomes are 7-day average score at baseline, and average change from baseline (CfB) at Day 90 and Day 365. Weekly daily average scores calculated for diaries completed at least 3 of 7 days.~The three domains are:~Sexual desire subscale 0=None, 1=very low to 7=Very High. Sexual enjoyment with/without partner subscale 0=None to 7=Very high enjoyment/pleasure. Partner availability not used in scoring. Positive CfB desirable.~Positive and negative mood subscales 0=Not at all true to 7=Very true (Likert 7-point scale, 7-day average reported). Positive mood (sum of 4 questions) score range = 0 to 28; positive changes from baseline desirable. Negative mood (sum of 5 questions) score range = 0 to 35; negative CfB desirable.~Weekly sexual activity subscale score is 7*(# of activities per week / # of days reported). Percent full erection uses scale of 0-100% (10% steps). Satisfaction with erection 0=not satisfactory to 7=very satisfactory. Positive CfB desirable." (NCT03198728)
Timeframe: Baseline (pre-treatment) to 90 days and 365 days

Intervention	score on a scale (Mean)
	Overall Level of sexual desire Visit 3 - Day 1 (baseline)	Overall Level of sexual desire Visit 8 - Day 90	Overall Level of sexual desire Visit Day 365	Without a Partner Visit 3 - Day 1 (baseline)	Without a Partner Visit 8 - Day 90	Without a Partner Visit Day 365	With a Partner Visit 3 - Day 1 (baseline)	With a Partner Visit 8 - Day 90	With a Partner Visit Day 365	Negative Mood Visit 3 - Day 1 (baseline)	Negative Mood Visit 8 - Day 90	Negative Mood Visit Day 365	Positive mood - Visit 3 - Day 1 (baseline)	Positive mood - Visit 8 - Day 90	Positive mood - Day 365	Sexual Activity Score Visit 3 - Day 1 (baseline)	Sexual Activity Score Visit 8 - Day 90	Sexual Activity Score Day 365	Erection Grade, Visit 3 - Day 1 (baseline)	Erection Grade, Visit 8 - Day 90	Erection Grade, Day 365	Erection Duration, Visit 3 - Day 1 (baseline)	Erection Duration, Visit 8 - Day 90	Erection Duration, Day 365
Andro-gel™ Treated	2.039	1.256	1.372	0.875	0.498	0.769	0.840	0.594	0.760	9.847	-1.886	-1.435	15.742	3.347	2.817	12.581	10.951	12.591	30.652	12.619	17.584	1.814	1.012	1.501
SOV2012-F1 Treated	1.990	1.674	1.552	0.754	0.742	0.920	0.954	1.168	1.106	9.258	-2.205	-3.011	16.799	2.513	3.407	15.314	12.284	12.009	32.145	17.494	14.235	1.985	1.480	1.300

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Change From Baseline in the SF-36

"Patient reported outcomes assessed by the Short-Form Survey (SF-36). This scale assesses 8 health concepts:~limitations in physical activities because of health problems~limitations in social activities because of physical or emotional problems~limitations in usual role activities because of physical health problems~bodily pain~general mental health (psychological distress and well-being)~limitations in usual role activities because of emotional problems~vitality (energy and fatigue)~general health perceptions.~Each domain is scored from 0-100 with a score of 0 = maximum disability and a score of 100 = no disability.~End of Treatment (EOT) occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure towards less disability. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and EOT scores." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT)

Intervention	score on a scale (Mean)
	Emotional Well-being (Baseline)	Emotional Well-being (End of Treatment)	Energy/Fatigue (Baseline)	Energy/Fatigue (End of Treatment)	General Health (Baseline)	General Health (End of Treatment)	Health Change (Baseline)	Health Change (End of Treatment)	Pain (Baseline)	Pain (End of Treatment)	Physical Functioning (Baseline)	Physical Functioning (End of Treatment)	Role Limitations due to Emotional Problems (Baseline)	Role Limitations due to Emotional Problems (End of Treatment)	Role Limitations due to Physical Health (Baseline)	Role Limitations due to Physical Health (End of Treatment)	Social Functioning (Baseline)	Social Functioning (End of Treatment)	Mental Health Composite (Baseline)	Mental Health Composite (End of Treatment)	Physical Health Composite (Baseline)	Physical Health Composite (End of Treatment)
Andro-Gel™ Treated	68.0	5.6	53.0	15.5	67.0	6.9	59.6	7.0	70.57	1.43	83.3	6.8	79.116	5.778	75.0	14.3	83.73	6.83	49.025	3.515	48.002	2.968
SOV2012-F1-Treated	72.4	7.1	61.0	16.6	69.0	3.5	65.2	14.6	77.17	4.16	85.5	3.6	85.317	12.081	82.1	12.4	84.75	9.31	51.885	5.478	49.229	1.558

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Change in Hormone SHBG

"Change in hormone Sex Hormone Binding Globulin (SHBG). The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment

Intervention	nmol/L (Mean)
	SHBG - Baseline	SHBG - Day 90	SHBG - Day 365	SHBG - End of Treatment
Andro-Gel™ Treated	24.52	0.26	1.60	1.39
SOV2012-F1-Treated	27.08	-8.99	-7.00	-6.25

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Change in TSH (Thyrotropin)

"Change from Baseline in Thyroid stimulating Hormone (TSH). The TSH test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365.~The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the TSH level." (NCT03198728)
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment

Intervention	mU/L (Mean)
	Thyrotropin - Baseline	Thyrotropin - Day 90	Thyrotropin - Day 365	Thyrotropin - End of Treatment
Andro-Gel™ Treated	2.407	0.343	0.122	0.081
SOV2012-F1-Treated	2.212	0.293	0.195	0.209

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Change in Sperm Counts From Baseline to 27 Weeks

Sperm count measured in million sperm/mL analyzed from semen sample (NCT03203681)
Timeframe: Baseline, 27 Weeks

Intervention	million sperm/mL (Mean)
Natesto	33.9

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Change in Estradiol Levels From Baseline to 27 Weeks

Estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw (NCT03203681)
Timeframe: Baseline, 27 Weeks

Intervention	pg/mL (Mean)
Natesto	21.6

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Change in Testosterone Levels From Baseline to 27 Weeks

Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw (NCT03203681)
Timeframe: Baseline, 27 Weeks

Intervention	ng/dL (Mean)
Natesto	652

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Number of Participants With an Increase in SF-36 QOL Scores From Baseline

The number of participants with an increase of at least 1 point from their SF-36 QOL scores from baseline will be reported. Short Form-36 (SF-36) Quality of Life (QOL) questionnaire has a proprietary scoring system that ranges from 1-5 and each domain is individually assessed (NCT03203681)
Timeframe: 27 Weeks

Intervention	Participants (Count of Participants)
Natesto	32

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Change in Gonadotropin Levels From Baseline to 27 Weeks

Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) levels, both measured in mIU/mL analyzed from peripheral venous puncture blood draw (NCT03203681)
Timeframe: Baseline, 27 Weeks

Intervention	mIU/mL (Mean)
	Follicle Stimulating Hormone	Luteinizing Hormone
Natesto	3.0	2.6

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Incidence of Adverse Events

Incidence of adverse events as assessed per treating physician (NCT03203681)
Timeframe: 27 Weeks

Intervention	Participants (Count of Participants)
	Azoospermia	Severe Oligospermia	Nasal irritation	sinusitis	epistaxis
Natesto	1	3	5	1	1

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Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range

Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range (NCT03242408)
Timeframe: Following 24 days of treatment

Intervention	Percent of participants (Number)
Oral Testosterone Undecanoate, LPCN 1021	69

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Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range

The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days). (NCT03242590)
Timeframe: Following 24 days of treatment

Intervention	Percent of participants (Number)
Oral Testosterone Undecanoate, LPCN 1021	80

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Radiographic Response Rate

Per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines, a radiographic response (as determined on CT or MRI) will be defined as: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT03516812)
Timeframe: Up to 2 years

Intervention	Participants (Count of Participants)
Treatment (Olaparib, Testosterone Enanthate or Cypionate)	8

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Percent of Patients With a Prostate-specific Antigen (PSA) Decline of at Least 50% Below Baseline PSA50 Response Rate

PSA response will be defined as a decline in PSA ≥ 50% compared to baseline in patients who received at least 12 weeks of treatment. Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a PSA response. (NCT03516812)
Timeframe: Median time to PSA50 response was 22 weeks.

Intervention	Participants (Count of Participants)
Treatment (Olaparib, Testosterone Enanthate or Cypionate)	14

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Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy + Nivolumab

Number of participants with PSA response to Bipolar Androgen Therapy + Nivolumab. PSA response is counted for participants with ≥ 50% decline in PSA from baseline. (NCT03554317)
Timeframe: 2 years

Intervention	Participants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab	18

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Safety of Bipolar Androgen Therapy + Nivolumab As Determined by the Number of CTCAEs ≥ Grade 3

Number of participants that experience adverse events grade ≥ 3, as defined by Common Terminology Criteria for Adverse Events (CTCAE). (NCT03554317)
Timeframe: 2 years

Intervention	Participants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab	5

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Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab

Number of participants without clinical/radiographic progression for > 6 months from the start of treatment. (NCT03554317)
Timeframe: 2 years

Intervention	Participants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab	15

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Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab

Median number of months from study enrollment to death from any cause up to 2 years after the last dose of study treatment received. (NCT03554317)
Timeframe: 3 years

Intervention	months (Median)
Bipolar Androgen Therapy + Nivolumab	24.4

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Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab

Percentage of patients achieving a complete or partial response in target lesions as defined by RECIST 1.1 Criteria. (NCT03554317)
Timeframe: 2 years

Intervention	percentage of overall participants (Number)
Bipolar Androgen Therapy + Nivolumab	18

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Progression-Free Survival (PFS) to Bipolar Androgen Therapy + Nivolumab

Median number of months from the time of the first dose to objective radiographic tumor progression or death, whichever comes first, as defined by RECIST 1.1 Criteria for progressive disease or death. (NCT03554317)
Timeframe: 2 years

Intervention	months (Median)
Bipolar Androgen Therapy + Nivolumab	5.6

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PSA Progression-Free Survival (PSA-PFS) to Bipolar Androgen Therapy + Nivolumab

Number of months from the time of initiation on Bipolar Androgen Therapy + Nivolumab therapy until PSA increase of 25% over a nadir value, confirmed by a follow-up PSA at least 4 weeks apart. (NCT03554317)
Timeframe: 2 years

Intervention	months (Number)
Bipolar Androgen Therapy + Nivolumab	4.0

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Change in ABPM-measured Average Nighttime PR

Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	bpm (Mean)
LPCN 1021	0.44

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Change is SBP Dip

Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	0.5

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Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5% (NCT03868059)
Timeframe: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)

Intervention	% Relative Change (Mean)
LPCN 1021	-33.4

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Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5% (NCT03868059)
Timeframe: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)

Intervention	% Relative Change (Mean)
LPCN 1021	-13.5

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Change in ABPM-measured Average Nighttime SBP

Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	4.3

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Change in Hemoglobin From Baseline

Change in Hemoglobin from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	g/dL (Mean)
LPCN 1021	0.87

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Change in Hematocrit From Baseline

Change in Hematocrit (%) from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to end of Study (approximately 4 months)

Intervention	percentage of hematocrit (Mean)
LPCN 1021	3.2

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Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg

Change in average 24-hour SBP as measured by ABPM in subjects with a baseline SBP >140mmHg from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	-3.0

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Change in Morning DBP Measured in Triplicate at the Clinic

Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	1.6

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Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a high cardiovascular risk based on their Framingham Risk Score (FRS≥24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	-1.8

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Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a low cardiovascular risk based on their Framingham Risk Score (0NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	2.6

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Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a moderate cardiovascular risk based on their Framingham Risk Score (11≤FRS<24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	4.8

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Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)

Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study) (NCT03868059)
Timeframe: Baseline to end of study (approximately 4 months).

Intervention	mmHg (Mean)
LPCN 1021	3.8

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Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10% (NCT03868059)
Timeframe: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)

Intervention	% Relative Change (Mean)
LPCN 1021	-39.7

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Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose

Number of participants who had to start a new hypertensive medication or increase their hypertensive medication dose from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	Participants (Count of Participants)
LPCN 1021	2

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Change in Patient Reported Sexual Desire

Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better) (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	units on a scale (Mean)
LPCN 1021	1.2

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Change in Morning PR Measured in Triplicate at the Clinic

Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	bpm (Mean)
LPCN 1021	2.0

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Change in Morning SBP Measured in Triplicate at the Clinic

Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	4.8

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Change in Patient Reported Sexual Distress

Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse) (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	units on a scale (Mean)
LPCN 1021	-0.3

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Change in ABPM-measured Average 24-hour Pulse Rate (PR)

Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	bpm (Mean)
LPCN 1021	2.0

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Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)

Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	1.2

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Change in ABPM-measured Average Daytime DBP

Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	1.7

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Change in ABPM-measured Average Daytime PR

Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	bpm (Mean)
LPCN 1021	2.6

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Change in ABPM-measured Average Daytime SBP

Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	5.2

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Change in ABPM-measured Average Nighttime DBP

Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	1.7

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Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10% (NCT03868059)
Timeframe: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)

Intervention	% Relative Change (Mean)
LPCN 1021	-38.5

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Wingate Peak Power

Anaerobic capacity was assessed using a Wingate anaerobic cycle test near the end of each study phase. (NCT04120363)
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Intervention	W (Least Squares Mean)
	Wingate peak power, absolute, Phase 1	Wingate peak power, absolute, Phase 2	Wingate peak power, absolute, Phase 3
Placebo	837.8	736.0	790.8
Testosterone	879.4	753.8	821.8

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Vertical Jump Height

Lower-body peak power was assessed near the end of each phase using a vertical jump test. (NCT04120363)
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Intervention	cm (Least Squares Mean)
	Vertical Jump Height, Phase 1	Vertical Jump Height, Phase 2	Vertical Jump Height, Phase 3
Placebo	53.6	50.0	50.5
Testosterone	54.5	49.1	54.0

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Total Mass Lifted

A 3-repetition maximum deadlift assessed muscular strength, endurance, and explosive power near the end of each study phase. (NCT04120363)
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Intervention	kg (Least Squares Mean)
	Total Mass Lifted, Phase 1	Total Mass Lifted, Phase 2	Total Mass Lifted, Phase 3
Placebo	127.9	119.0	129.8
Testosterone	127.4	122.7	126.7

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Peak Aerobic Capacity

Peak aerobic capacity was measured via treadmill VO2peak near the end of each study phase. (NCT04120363)
Timeframe: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Intervention	L/min (Least Squares Mean)
	VO2peak, absolute, Phase 1	VO2peak, absolute, Phase 2	VO2peak, absolute, Phase 3
Placebo	3.28	3.20	3.44
Testosterone	3.22	3.13	3.29

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Load Carriage Time

A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance. (NCT04120363)
Timeframe: Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)

Intervention	min (Least Squares Mean)
	2.5 mile time, Phase 1	2.5 mile time, Phase 2	2.5 mile time, Phase 3
Placebo	41.58	47.15	39.34
Testosterone	45.21	50.95	44.31

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Body Composition

A four-compartment (4C) model factoring in body mass, body volume, total body water, and bone mineral content was used to calculate fat-free body mass and fat mass at the end of each study phase. (NCT04120363)
Timeframe: Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3)

Intervention	kg (Least Squares Mean)
	Fat-free Mass at end of Phase 1	Fat-free Mass at end of Phase 2	Fat-free Mass at end of Phase 3	Fat Mass at end of Phase 1	Fat Mass at end of Phase 2	Fat Mass at end of Phase 3
Placebo	59.8	57.9	59.6	17.5	14.4	15.5
Testosterone	59.2	59.6	59.5	17.3	13.0	15.1

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Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment in LPCN 1144 Treated Subjects Compared to Placebo.

Intervention	NAS score (Least Squares Mean)
	Hepatocyte ballooning score	Lobular inflammation score	Steatosis score
Treatment A	-0.7	-0.2	-0.9
Treatment B	-0.9	-0.5	-1.2
Treatment C	-0.2	-0.1	-0.1

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Relative Change in Whole Body Fat Mass

Relative change in whole body fat mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward. (NCT04134091)
Timeframe: Baseline and week 36

Intervention	Percentage change (Least Squares Mean)
Treatment A	-3.68
Treatment B	-7.33
Treatment C	1.78

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Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.

Requirement for inclusion in analysis was having a baseline hepatic fat fraction ≥ 5% based on MRI-PDFF. (NCT04134091)
Timeframe: Baseline and week 12

Intervention	Percentage change (Least Squares Mean)
Treatment A	-39.94
Treatment B	-46.84
Treatment C	-9.34

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Relative Change in Appendicular Lean Muscle Mass

Relative change in appendicular lean muscle mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward. (NCT04134091)
Timeframe: Baseline and 36 weeks

Intervention	Percentage change (Least Squares Mean)
Treatment A	2.75
Treatment B	1.90
Treatment C	-1.42

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Number of Subjects Achieving Resolution of NASH on Overall Histopathological Reading and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.

Resolution of NASH is defined as NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8. No worsening was defined as a score in fibrosis equal to, or lower, than baseline. (NCT04134091)
Timeframe: Baseline and Week 36

Intervention	Participants (Count of Participants)
Treatment A	6
Treatment B	9
Treatment C	0

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Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.

The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo. (NCT04134091)
Timeframe: Baseline and Week 12

Intervention	Percentage of liver fat (Least Squares Mean)
Treatment A	-7.68
Treatment B	-9.17
Treatment C	-1.54

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Number of Participants With Resolution of NASH on Overall Histopathological Reading in LPCN 1144 Treated Subjects Compared to Placebo

Resolution of nonalcoholic steatohepatitis (NASH) is defined as the nonalcoholic fatty liver disease activity score (NAS) score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-clinical research network (CRN) histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8. (NCT04134091)
Timeframe: Baseline and Week 36

Intervention	Participants (Count of Participants)
Treatment A	7
Treatment B	9
Treatment C	1

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Number of Subjects With an Improvement in Liver Fibrosis Greater Than or Equal to One Stage and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo.

These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, and fibrosis stage 0-4. Improvement in liver fibrosis was defined as an improvement in fibrosis greater than or equal to one stage using the NASH CRN fibrosis score with no worsening of ballooning, inflammation, or steatosis. (NCT04134091)
Timeframe: Baseline and Week 36

Intervention	Participants (Count of Participants)
Treatment A	4
Treatment B	2
Treatment C	6

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Number of Subjects With Improvement in Fibrosis Evaluated by Paired Biopsies Analysis and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo

Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in fibrosis requires a better score in fibrosis and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening. (NCT04134091)
Timeframe: Baseline to week 36

Intervention	Participants (Count of Participants)
Treatment A	6
Treatment B	8
Treatment C	3

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Number of Subjects With Improvement in Fibrosis Evaluated Via FibroNest Scores

Improvement in Fibrosis is defined as improvement in parenchymal tissue normalized phenotypic fibrosis composite value compared to baseline. FibroNest is an image analysis system for the assessment of the severity and progression of fibrosis in NASH, produced by PharmaNest LLC. (NCT04134091)
Timeframe: Baseline and week 36

Intervention	Participants (Count of Participants)
Treatment A	12
Treatment B	6
Treatment C	5

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Number of Subjects With Improvement in NASH Evaluated by Paired Biopsies Analysis and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.

Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in NASH requires no worsening of fibrosis, an improvement in ballooning or inflammation, and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening. (NCT04134091)
Timeframe: Baseline and week 36

Intervention	Participants (Count of Participants)
Treatment A	9
Treatment B	8
Treatment C	2

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Mean Change From Baseline in Liver Enzymes in LPCN 1144 Treated Subjects Compared to Placebo.

Liver enzymes analyzed were aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT) (NCT04134091)
Timeframe: Baseline and Week 36

Intervention	U/L (Least Squares Mean)
	Aspartate transaminase (AST)	Alanine transaminase (ALT)	Alkaline phosphatase (ALP)	Gamma-glutamyltransferase (GGT)
Treatment A	-8.0	-11.4	-6.1	-2.9
Treatment B	-12.0	-22.9	-8.5	-13.4
Treatment C	1.3	0.6	0.1	0.7

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Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.

Lipid profile parameters included total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides. (NCT04134091)
Timeframe: Baseline and Week 36

Intervention	mg/dL (Least Squares Mean)
	Total Cholesterol	LDL	HDL	Triglycerides
Treatment A	-1.7	1.8	-3.3	-11.5
Treatment B	7.3	8.7	-2.0	-3.9
Treatment C	1.1	-6.0	-0.0	67.3

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Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)

Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day). (NCT04274894)
Timeframe: Baseline, Week 16

Intervention	mmHg (Mean)
AndroGel 1.62%	1.9

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Change From Baseline in 24-hour Average Mean Arterial Pressure (MAP) Obtained at Week 16

MAP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged. (NCT04320745)
Timeframe: Baseline and Week 16

Intervention	mmHg (Mean)
	Baseline	Change from Baseline at Week 16
Androderm® 4 mg	90.4	1.7

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Change From Baseline in 24-hour Average Systolic Blood Pressure (SBP) Obtained at Week 16

SBP was collected by 24-hour ambulatory blood pressure monitoring (ABPM) device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged. (NCT04320745)
Timeframe: Baseline and Week 16

Intervention	millimeters of mercury (mmHg) (Mean)
	Baseline	Change from Baseline at Week 16
Androderm® 4 mg	123.2	3.5

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Change From Baseline in 24-hour Average Pulse Pressure Obtained at Week 16

Pulse pressure was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged. (NCT04320745)
Timeframe: Baseline and Week 16

Intervention	mmHg (Mean)
	Baseline	Change From Baseline at Week 16
Androderm® 4 mg	48.8	2.3

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Change From Baseline in 24-hour Average Diastolic Blood Pressure (DBP) Obtained at Week 16

DBP was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged. (NCT04320745)
Timeframe: Baseline and Week 16

Intervention	mmHg (Mean)
	Baseline	Change from Baseline at Week 16
Androderm® 4 mg	74.4	1.2

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Change From Baseline in 24-hour Average Heart Rate Obtained at Week 16

Heart rate was collected by 24-hour ABPM device. 24-hour ABPM is defined as any assessment recorded at the specified analysis timepoint (baseline, Week 16) during the approximately 24-hour period after the ABPM device is applied through when the ABPM device is removed. BP parameters were collected at a minimum of 2 readings per hour for 24-hour recordings and were averaged. (NCT04320745)
Timeframe: Baseline and Week 16

Intervention	beats per minute (bpm) (Mean)
	Baseline	Change From Baseline at Week 16
Androderm® 4 mg	72.4	2.2

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Change in Hormone Levels

Change in serum hormone levels including Testosterone, 17-Hydroxyprogesterone (17-OHP) assessed in ng/dL. (NCT04439799)
Timeframe: Baseline to 4 months

Intervention	ng/dL (Mean)
	Testosterone	17-OHP
Natesto Group	283	-8.8
Testosterone Cypionate Group	511	-39.8

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Changes in IIEF-6 Score

The International Index of Erectile Function (IIEF)-6 is a 6-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-30 with the higher score indicating better erectile function. (NCT04439799)
Timeframe: Baseline to 4 months

Intervention	score on a scale (Mean)
Testosterone Cypionate Group	4.8
Natesto Group	0.2

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Change in PSA Levels

Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL. (NCT04439799)
Timeframe: Baseline to 4 months

Intervention	ng/mL (Mean)
Testosterone Cypionate Group	0.6
Natesto Group	0.05

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Change in Hematocrit (Hct) Levels.

Changes in serum Hematocrit levels will be assessed in percentage (NCT04439799)
Timeframe: Baseline to 4 months

Intervention	percentage of hematocrit (Mean)
Testosterone Cypionate Group	3.0
Natesto Group	-0.6

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Change in Estradiol Levels

Change in serum estradiol levels will be assessed in pg/mL. (NCT04439799)
Timeframe: Baseline to 4 months

Intervention	pg/mL (Mean)
Testosterone Cypionate Group	22.9
Natesto Group	1.1

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Change in Estradiol Levels

Change in serum estradiol levels are assessed in pg/mL. (NCT04523480)
Timeframe: Baseline, 2 months, 4 months, and 6 months

Intervention	pg/mL (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	20.6	42.7	18.4	18.8
Testopel 75mg Group	18.2	29.1	13.7	14.3

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Change in Hematocrit (Hct) Levels.

Changes in serum Hct levels are assessed in %. (NCT04523480)
Timeframe: Baseline, 2 months, 4 months, and 6 months

Intervention	hematocrit percentage (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	42.8	46.7	45.8	43
Testopel 75mg Group	43.7	46.1	45.9	46

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Change in PSA Levels

Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL. (NCT04523480)
Timeframe: Baseline, 2 months, 4 months, and 6 months

Intervention	ng/mL (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	0.4	0.75	0.65	0.5
Testopel 75mg Group	0.9	1.1	1	0.8

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Change in Testosterone (T) Levels

Changes in serum Testosterone levels are assessed in ng/dL (NCT04523480)
Timeframe: Baseline, 2 months, 4 months, and 6 months

Intervention	ng/dL (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	202.3	696.5	277	241
Testopel 75mg Group	219.5	543	290	209

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Serum Testosterone Levels

Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw (NCT04983940)
Timeframe: Up to 6 months

Intervention	ng/dL (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	200.3	486.8	649.3

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PSA Levels Measured in ng/mL

Prostate Specific Antigen (PSA) levels measured in ng/mL analyzed from peripheral venous puncture blood draw. (NCT04983940)
Timeframe: Up to 6 months

Intervention	ng/mL (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	1.06	1.14	0.95

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Patient Satisfaction as Measured by TSQM-9 (Global Satisfaction Domain)

Treatment Satisfaction Questionnaire for Medication (TSQM-9) has three domains (Global, Convenience, and Effectiveness), each with a total score ranging from 0 to 100 with the higher score indicating higher patient satisfaction. (NCT04983940)
Timeframe: Up to 6 months

Intervention	score on a scale (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	66.7	83.1	83.7

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Hematocrit Levels

Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw. (NCT04983940)
Timeframe: Up to 6 months

Intervention	percentage of hematocrit (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	44.9	45	45.2

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Serum Estradiol Levels

Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw. (NCT04983940)
Timeframe: Up to 6 months

Intervention	pg/mL (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	14.4	21.6	21.2

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Hypogonadal Symptoms as Measured by qADAM Questionnaire

Quantitative Androgen Deficiency in the Aging Male (qADAM) has a total score ranges between 10 (most symptomatic) and 50 (least symptomatic). (NCT04983940)
Timeframe: Up to 6 months

Intervention	score on a scale (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	36.6	34.4	35.5

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Condition	Relationship Strength	Studies
Innate Inflammatory Response [description not available]	2.05	1
Inflammation A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.	2.05	1
Plasmodium falciparum Malaria [description not available]	2.1	1
Malaria, Falciparum Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.	2.1	1
Anemia, Fanconi [description not available]	2.13	1
Fanconi Anemia Congenital disorder affecting all bone marrow elements, resulting in ANEMIA; LEUKOPENIA; and THROMBOPENIA, and associated with cardiac, renal, and limb malformations as well as dermal pigmentary changes. Spontaneous CHROMOSOME BREAKAGE is a feature of this disease along with predisposition to LEUKEMIA. There are at least 7 complementation groups in Fanconi anemia: FANCA, FANCB, FANCC, FANCD1, FANCD2, FANCE, FANCF, FANCG, and FANCL. (from Online Mendelian Inheritance in Man, http://www.ncbi.nlm.nih.gov/entrez/dispomim.cgi?id=227650, August 20, 2004)	2.13	1

testosterone

Cross-References

Synonyms (57)

Roles (1)

Drug Classes (1)

Protein Targets (8)

Potency Measurements

Biological Processes (5)

Molecular Functions (2)

Ceullar Components (1)

Bioassays (17)

Research

Studies (9)

Study Types

Clinical Trials (458)

Trial Overview

Trial Outcomes

MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.

Markers of Bone Metabolism

Bone Mineral Density

Safety: Number of Subjects Reporting a Skin Reaction to the Patch

Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)

Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)

Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function

Quality of Life/Depression: Becks Depression Inventory

Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.

Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.

Safety: Number of Subjects Reporting Acne

Lean Body Mass

Bone Mineral Density of the Hip

"Neurocognitive Function: Hopkins Verbal Learning Test-revised,Total Recall Z Score Represents Change in Z Score From Baseline to 18 Months."

Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release

Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function

Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density

Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism

Lower Body Muscle Strength (1-RM, kg)

Fat Free Mass (kg)

Physical Function (CS-PFP Total Score)

Fat Mass (kg)

Power (Power Rig, Watts)

Upper Body Muscle Strength (1-RM, kg)

Change in Erectile Function Symptoms

Change in Libido / Sexual Desire

Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)

Percentage Change in Body Composition: Fat Mass

Percentage Change in Thigh Muscle Area

Fatigue Impact Scale

Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.

Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.

Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)

Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume

Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)

The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)

Myocardial Perfusion

Endothelial Function

Grip Strength

Late Life Functional Disability Index (LLFDI)

Stair-climbing Test (Loaded)

50-Meter Walking Speed (With a Load)

Total Fat Mass

Total Lean Mass

Stair-climbing Test (Without a Load)

50-Meter Walking Speed (Without a Load)

Changes in Physical Performance Measured by an Exercise Testing Regimen

Chest-Press

Resting Energy Expenditure

Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)

Change From Baseline in Chest Press Strength and Leg Press Strength

Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)

Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)

Change From Baseline in Lipid Profiles

Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)

Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)

Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power

Change From Baseline in the Verbal Fluency Test

Change From Baseline in Coronary Artery Calcium Score

Change From Baseline in Paragraph Recall Test (Delayed)

Change From Baseline in the Trail Making Test B

Change From Baseline in the Stroop Interference Test

Change From Baseline in the Category Fluency Test