Page last updated: 2024-12-05

testosterone enanthate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID9416
CHEMBL ID1200335
CHEBI ID9464
SCHEMBL ID42687
MeSH IDM0045776

Synonyms (132)

Synonym
AC-12599
delatestryl
androst-4-en-3-one, 17-[(1-oxoheptyl)oxy]-, (17.beta.)-
LMST02020075
17-heptanoyl-17beta-hydroxyandrost-4-en-3-one
exten test
androst-4-en-3-one,(17.beta.)-
testostroval
testosterone heptylate
delatest
reposo-tmd
androtardyl
androst-4-en-3-one, heptanoate
testosterone heptoate
everone
atlatest
testoenant
malogen l.a.
nsc-17591
testonenant
orquisteron-e
testosterone, heptanoate
testosterone oenanthate
heptanoic acid, ester with testosterone
nsc17591
testanthate
depo-testro med
testinon
testosterone heptanoate
wln: l e5 b666 ov mutj a e fov6
17-hydroxyandrost-4-en-3-one, 17-heptanoate
testate
3-oxoandrost-4-en-17beta-yl heptanoate
CHEBI:9464 ,
17beta-hydroxyandrost-4-en-3-one heptanoate
C08157
315-37-7
testosterone enanthate
testosterone enanthate (jp17/usp)
delatestryl (tn)
D00958
testosterone enantate
einecs 206-253-5
depatestrye
dea no. 4000
reposo tmd
andro l.a. 200
androst-4-en-3-one, 17beta-hydroxy-, heptanoate
malogen l.a.200
17beta-enanthoxyandrost-4-en-3-one
ditate
17beta-hydroxyandrost-4-en-3-one enanthate
androst-4-en-3-one, 17-(1-oxoheptyl)oxy-, (17beta)-
durathate
4-androsten-3-one 17beta-enanthate
androst-4-en-3-one, 17-((1-oxoheptyl)oxy)-, (17beta)-
17-((1-oxoheptyl)oxy)androst-4-en-3-one
brn 3170544
testenate
ccris 7082
testosterone 17-enanthate
andropository
[(8r,9s,10r,13s,14s,17s)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] heptanoate
xyosted
CHEMBL1200335
testosterone enanthate ciii
testosteroni enantas
S3717
AKOS015960945
7z6522t8n9 ,
testosterone enanthate [usp:jan]
androgyn l.a.
4-08-00-00979 (beilstein handbook reference)
unii-7z6522t8n9
testosterone ethanate
testosteroni enantas [who-ip latin]
testosterone enanthate [mi]
testosterone enanthate [vandf]
ditate-ds component testosterone enanthate
testosterone enantate [mart.]
testosterone enantate [who-ip]
testosterone enanthate [usp-rs]
testosterone enantate [ep monograph]
testosterone enanthate ciii [usp-rs]
testosterone enanthate [jan]
testosterone enanthate [usp monograph]
17.beta.-(heptanoyloxy)androst-4-en-3-one [who-ip]
testosterone enanthate [orange book]
testosterone enanthate [who-dd]
androst-4-en-3-one, 17-(1-oxoheptyl)oxy-, (17.beta.)-
testosterone enanthate component of ditate-ds
SCHEMBL42687
W-106891
deladumone (salt/mix)
3-oxoandrost-4-en-17-yl heptanoate, (17.beta.)- #
androst-4-en-3-one, 17.beta.-hydroxy-, heptanoate
androgyn l.a. (salt/mix)
4-androsten-3-one 17.beta.-enanthate
17-[(1-oxoheptyl)oxy]androst-4-en-3-one
ditate (salt/mix)
androst-4-en-3-one, 17-[(1-oxoheptyl)oxy]-, (17b)-
(8r,9s,10r,13s,14s,17s)-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl heptanoate
sr-01000942262
SR-01000942262-1
testosterone enanthate, united states pharmacopeia (usp) reference standard
testosterone 17beta-heptanoate
testosterone heptoic acid
testosterone 17beta-heptanoic acid
4-androsten-17beta-ol-3-one 17-enanthate
testosterone enanthate, analytical standard
testosterone enantate, european pharmacopoeia (ep) reference standard
testosterone enantate for system suitability, european pharmacopoeia (ep) reference standard
testosterone enantate for peak identification, european pharmacopoeia (ep) reference standard
DB13944
DS-11585
Q27108402
17-hydroxyandrost-4-en-3-one, 17-heptanoic acid
DTXSID701016540 ,
CCG-268655
andro la
testosterone enanthate (usp-rs)
testosterone enanthate (usp monograph)
testosterone enantate (ep monograph)
testosterone enanthate ciii (usp-rs)
testo-enant
xyosted (autoinjector)
primosteston
testosterone enantate (mart.)
dtxcid901474730
testosterone enanthate (usp:jan)
17beta-(heptanoyloxy)androst-4-en-3-one
testosterone 17-heptanoate

Research Excerpts

Treatment

ExcerptReferenceRelevance
"Testosterone enanthate treatment increased serum testosterone levels by 91.1% (p .01), serum osteocalcin by 35.7% (p .05), and the serum immunoreactive parathyrin by 41.4% (p .05)."( Body composition and muscle strength in healthy men receiving testosterone enanthate for contraception.
Baker, HW; Liu, G; Seeman, E; Young, NR, 1993
)
1.25

Toxicity

ExcerptReferenceRelevance
" We have previously demonstrated that 100 microM testosterone cypionate (TC) inhibits all beating activity of primary neonatal rat myocardial cell cultures within 1 hr of exposure and causes significant LDH release by 4 hr of exposure, indicating a direct toxic effect of TC."( Anabolic-androgenic steroid-induced toxicity in primary neonatal rat myocardial cell cultures.
Fugate, RD; Melchert, RB; Robertson, JW; Welder, AA, 1995
)
0.29
" There were no significant adverse effects based on comprehensive physical examinations, urea, electrolytes, and renal or liver function tests."( Pharmacokinetics, bioefficacy, and safety of sublingual testosterone cyclodextrin in hypogonadal men: comparison to testosterone enanthate--a clinical research center study.
Alexander, G; Berman, N; Davidson, T; Dudley, RE; McDonald, V; Salehian, B; Swerdloff, RS; Wang, C; Ziel, F, 1995
)
0.5
" In summary, the contraceptive efficacy for male contraception in this study demonstrated that weekly injections of testosterone enanthate can provide safe and effective contraceptive protection."( Contraceptive efficacy and adverse effects of testosterone enanthate in Thai men.
Aribarg, A; Chanprasit, Y; Kriangsinyos, R; Ngeamvijawat, J; Sukcharoen, N, 1996
)
0.76
" Although this study confirms testosterone's well-sustained suppression of spermatogenesis and lack of short-term adverse effects, long-term effects on cardiovascular and prostatic disease require investigation."( Contraceptive efficacy and adverse effects of testosterone enanthate in Thai men.
Aribarg, A; Chanprasit, Y; Kriangsinyos, R; Ngeamvijawat, J; Sukcharoen, N, 1996
)
0.55
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" The current study demonstrated adverse effects of male chloropyrifos exposure on pregnancy outcome with effects on sperm parameters at 15 and 25mg/kg-d."( Chlorpyrifos induced reproductive toxicity in male mice.
El Okazy, A; El-Agamy, el-S; El-Sebae, Ael-K; Farag, AT; Radwan, AH; Sorour, F, 2010
)
0.36
" Our study presents the longest follow-up published so far reporting no adverse events and these data are consistent with previous reports with a shorter follow-up."( Testosterone undecanoate and testosterone enanthate injections are both effective and safe in transmen over 5 years of administration.
Baldassarre, M; Cerpolini, S; Gava, G; Mancini, I; Meriggiola, MC; Seracchioli, R, 2018
)
0.77
" Safety, including ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK were assessed."( Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study.
Gittelman, M; Jaffe, JS; Kaminetsky, JC, 2019
)
0.81
"6%) experienced adverse drug reactions; the most frequently reported were increased hematocrit (≥52%) in 10 patients (7."( Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study.
Gittelman, M; Jaffe, JS; Kaminetsky, JC, 2019
)
0.81
" Therapeutic phlebotomy was recommended for HCT > 54%, and treatment was discontinued for significant increases in PSA as well as for significant treatment-related adverse events."( Post-market safety and efficacy profile of subcutaneous testosterone enanthate-autoinjector: a cohort analysis.
Choi, EJ; El-Khatib, FM; Kavoussi, PK; Xu, P; Yafi, FA, 2022
)
0.97

Pharmacokinetics

ExcerptReferenceRelevance
" Mean half-life estimates of the terminal elimination phase were 4 and 7 days for testosterone-enanthate and dihydrotestosterone-enanthate, respectively."( Pharmacokinetics and pharmacodynamics of testosterone enanthate and dihydrotestosterone enanthate in non-human primates.
Behre, HM; Jackwerth, B; Nieschlag, E; Weinbauer, GF; Yeung, CH; Yoon, YD, 1990
)
0.54
" We therefore tested two groups of five long-term orchidectomized cynomolgus monkeys (Macaca fascicularis), which received a single intramuscular injection of 10 mg/kg body weight of an injectable testosterone undecanoate (TU) preparation or testosterone enanthate (TE) in a preclinical study to assess the pharmacokinetic and pharmacodynamic characteristics of TU in comparison to TE."( Injectable testosterone undecanoate has more favourable pharmacokinetics and pharmacodynamics than testosterone enanthate.
Fang, R; Nieschlag, E; Partsch, CJ; Weinbauer, GF, 1995
)
0.69
" Acute pharmacokinetic testing showed peak serum hormone levels at 30 min, with a mean serum T concentration of 2688 +/- 147 ng/dL (range, 1820-3770 ng/dL)."( Pharmacokinetic characteristics, efficacy, and safety of buccal testosterone in hypogonadal males: a pilot study.
Allen, R; Chen, MC; Dobs, AS; Hoover, DR, 1998
)
0.3
" Subsequent injections of TE caused a similar pharmacokinetic profile until the 55th injection; testosterone levels on day 3 declined from the 56 to 58th injection and remained in a lower range until the last injection."( Effects of long-term treatment with testosterone enanthate in rhesus monkeys: I. Pharmacokinetics of testosterone, testicular volume and liver metabolism of testosterone.
Bajaj, JS; Kumar, VM; Rajalakshmi, M; Tyagi, A, 1999
)
0.58
"Currently available testosterone (T) preparations differ substantially in their pharmacokinetic profile that might influence their androgenic properties in terms of suppression of the gonadal axis, effects on anabolic parameters, lipid metabolism, and erythropoiesis."( Pharmacokinetics and degree of aromatization rather than total dose of different preparations determine the effects of testosterone: a nonhuman primate study in Macaca fascicularis.
Nieschlag, E; Partsch, CJ; Schlatt, S; Weinbauer, GF; Zitzmann, M,
)
0.13
" Therefore, we conducted a pharmacokinetic study of oral T and TE in oil, with and without concomitant D, in normal men whose T production had been temporarily suppressed by the GnRH antagonist acyline."( Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study.
Amory, JK; Bremner, WJ, 2005
)
0.33

Compound-Compound Interactions

ExcerptReferenceRelevance
"We administered Nal-Glu at doses of 0, 100, and 200 micrograms/kg body weight per day in combination with T enanthate, 50 mg IM weekly, to separate groups of men (9 or 10 men per group) for 4 weeks."( Dose effects of the gonadotropin-releasing hormone antagonist, Nal-Glu, combined with testosterone enanthate on gonadotropin levels in normal men.
Bagatell, CJ; Bremner, WJ; Rivier, JE, 1995
)
0.51
"Administration of Nal-Glu in combination with T suppresses gonadotropins more completely than does T alone, but at doses > 100 micrograms/kg, gonadotropins are not suppressed additionally with larger doses of Nal-Glu."( Dose effects of the gonadotropin-releasing hormone antagonist, Nal-Glu, combined with testosterone enanthate on gonadotropin levels in normal men.
Bagatell, CJ; Bremner, WJ; Rivier, JE, 1995
)
0.51
"The effects of a synthetic oral progestogen, desogestrel (DSG), administered with low dose testosterone (T) were investigated to determine the optimal combination for suppression of gonadotropins and spermatogenesis to targets compatible with effective male contraception."( Oral progestogen combined with testosterone as a potential male contraceptive: additive effects between desogestrel and testosterone enanthate in suppression of spermatogenesis, pituitary-testicular axis, and lipid metabolism.
Balasubramanian, R; Coelingh-Bennink, HJ; Mulders, TM; Wu, FC, 1999
)
0.51

Bioavailability

ExcerptReferenceRelevance
"The effects of long-term administration of testosterone enanthate on the pharmacokinetics and bioavailability of testosterone were studied in adult male rhesus monkeys (n = 9), injected with 50 mg of testosterone enanthate (TE) once every 14 days for a total of 32 months."( Effects of long-term treatment with testosterone enanthate in rhesus monkeys: I. Pharmacokinetics of testosterone, testicular volume and liver metabolism of testosterone.
Bajaj, JS; Kumar, VM; Rajalakshmi, M; Tyagi, A, 1999
)
0.84
" It is reasonable to believe that the genetic variation in testosterone bioavailability may be correlated to varying effects of this androgen, whether it is used for replacement therapy or abused in doping."( Bioavailability of testosterone enanthate dependent on genetic variation in the phosphodiesterase 7B but not on the uridine 5'-diphospho-glucuronosyltransferase (UGT2B17) gene.
Belanger, A; Ekström, L; Guillemette, C; Rane, A; Schulze, JJ, 2011
)
0.7

Dosage Studied

Testosterone enanthate is an experimental inhibitor of spermatogenesis (contraceptive agent) We conclude that in GH- and gonadotropin-deficient boys a reduced dosage of testosterone should be used to induce pubertal development.

ExcerptRelevanceReference
" There was no significant difference in the suppression of spermatogenesis between the two dosage regimens."( Reversible azoospermia induced by an androgen-progestin combination regimen in Indonesian men.
Pangkahila, W, 1991
)
0.28
" In either case, the results are the most promising to date and raise the possibility that constant delivery of a higher dosage of agonist could produce azoospermia in most or all subjects."( Gonadotropin releasing hormone (GnRH) agonists in male contraception.
Bhasin, S; Steiner, BS; Swerdloff, RS, 1986
)
0.27
" We conclude that in GH- and gonadotropin-deficient boys 1) a reduced dosage of testosterone enanthate (25 mg twice a month, im) should be used to induce pubertal development, and 2) the major criterion to decide when to give testosterone is height reached at that time regardless of bone age."( Pubertal growth and final height in hypopituitary boys: a minor role of bone age at onset of puberty.
Bourguignon, JP; Du Caju, M; Ernould, C; Malvaux, P; Vanderschueren-Lodeweyckx, M; Vandeweghe, M; Wolter, R, 1986
)
0.5
" Then, while continuing the same dosage of T enanthate, all four men simultaneously received 5000 IU of hCG im three times weekly for 6 months, replacing LH-like activity and leaving FSH activity suppressed."( Stimulation of sperm production by human chorionic gonadotropin after prolonged gonadotropin suppression in normal men.
Bremner, WJ; Matsumoto, AM,
)
0.13
" These changes are considered as a regulative phenomenon, without consequences for the application of the high dosage therapy with these steroid hormones in the treatment of excessive growth."( Effects of high doses of oestrogens and androgens on lipoproteins: observations in the treatment of excessive growth with sexual hormones.
Hanefeld, M; Hinkel, GK; Jaross, W; Leonhardt, W; Trübsbach, A, 1985
)
0.27
" An additional three subjects received testosterone enanthate alone in identical dosage for 20 weeks."( Combined treatment with an LHRH agonist and testosterone in man. Reversible oligozoospermia without impotence.
Alexander, AN; Doelle, GC; Evans, RM; Linde, R; Rabin, D; Rivier, J; Vale, W,
)
0.4
"To determine the relative efficacy of several dosage regimens of testosterone enanthate in the treatment of male hypogonadism, we treated men who had primary hypogonadism with the following dosage regimens: 100 mg once a week, 200 mg every 2 weeks, 300 mg every 3 weeks, and 400 mg every 4 weeks, each for 12--16 weeks."( Treatment of male hypogonadism with testosterone enanthate.
Lawrence, DA; Snyder, PJ, 1980
)
0.77
" A similar dosage would be recommended if testosterone enanthate were to be used as an experimental inhibitor of spermatogenesis (contraceptive agent)."( Comparison of the kinetics of injectable testosterone in eugonadal and hypogonadal men.
Campfield, LA; Palacios, A; Saul, C; Sokol, RZ; Swerdloff, RS, 1982
)
0.53
" The dosage and the different administration schedule of the hormone combination described here was inadequate to maintain azoospermia in all subjects during treatment."( Spermatogenesis in men treated with injections of medroxyprogesterone acetate combined with testosterone enanthate.
Danner, C; Frick, J; Joos, H; Köhle, R; Kunit, G, 1982
)
0.48
" The lowest dosage T administration did not affect the androgen profile, while higher dosages generally increased urinary excretions of T metabolites (TG, T sulfate, glucuronides of androsterone, etiocholanolone, 5 alpha- and 5 beta-androstane-3 alpha,17 beta-diol) and decreased excretions of conjugates of epitestosterone (ET) and its precursor androgen 5-androstene-3 beta,17 alpha-diol."( Long-term administration of testosterone enanthate to normal men: alterations of the urinary profile of androgen metabolites potentially useful for detection of testosterone misuse in sport.
Dehennin, L; Matsumoto, AM, 1993
)
0.58
" However, there is a wide range of testosterone dosage and no standardized test."( [Androgen test: comparison of a low test and a high test in the development of the penis in male pseudohermaphroditism].
Pienkowski, C; Rochiccioli, P; Sultan, C; Tauber, MT; Wakim, S, 1996
)
0.29
" We hypothesized that a combination of physiologic exogenous testosterone and lower dosage LNG would result in uniform severe oligoazoospermia or azoospermia in normal men but would cause fewer adverse metabolic side effects."( A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations.
Anawalt, BD; Bebb, RA; Bremner, WJ; Matsumoto, AM,
)
0.13
" TE was given at a dosage of 25 mg intramuscularly, and PL was measured at least 4 weeks after the injection."( Testosterone enanthate therapy is effective and independent of SRD5A2 and AR gene polymorphisms in boys with micropenis.
Hasegawa, T; Ishii, T; Matsuo, N; Ogata, T; Sasaki, G; Sato, S, 2004
)
1.77
" We hypothesized that intramuscular T enanthate 100 mg weekly plus a very low dosage of oral LNG would effectively suppress spermatogenesis in normal men without inducing weight gain or HDL suppression."( Intramuscular testosterone enanthate plus very low dosage oral levonorgestrel suppresses spermatogenesis without causing weight gain in normal young men: a randomized clinical trial.
Amory, JK; Anawalt, BD; Bremner, WJ; Coviello, AD; Herbst, KL; Matsumoto, AM; Page, ST,
)
0.49
" Conversely, each rats group was further subdivided: no further treatment or acute sildenafil dosing (25 mg/kg, 1 hour before "in vivo" electrical stimulation [ES])."( Testosterone restores diabetes-induced erectile dysfunction and sildenafil responsiveness in two distinct animal models of chemical diabetes.
Donati, S; Filippi, S; Forti, G; Luconi, M; Maggi, M; Morelli, A; Vignozzi, L; Zhang, XH, 2006
)
0.33
" Thereafter, a dose-response effect of different doses of benzylglucosinolates (0."( Effect of two different extracts of red maca in male rats with testosterone-induced prostatic hyperplasia.
Gasco, M; Gonzales, GF; Maldonado, C; Mormontoy, J; Pajuelo, M; Portella, J; Rodriguez, D; Vasquez, V; Villegas, L, 2007
)
0.34
"5 mg/kg for 5 days + 16 days of recovery), subgroups b received the same chemotherapy regimen with adjuvant high-dose T enanthate (5 mg/100 g body weight) starting 1 week before chemotherapy and repeated every 21 days during chemotherapy, subgroups c received only high-dose T enanthate at the same dosage and intervals; subgroups d received a placebo."( Preventive role of exogenous testosterone on cisplatin-induced gonadal toxicity: an experimental placebo-controlled prospective trial.
Aminsharifi, A; Ariafar, A; Karbalaeedoost, S; Kumar, PV; Moeinjahromi, B; Shakeri, S, 2010
)
0.36
" We conducted a dose-response analysis of testosterone replacement therapy (TRT) in 138 patients to determine the onset of the therapeutic effects."( Dose-response analysis of testosterone replacement therapy in patients with female to male gender identity disorder.
Ishii, K; Kaku, H; Kumon, H; Mahmood, S; Nagai, A; Nakamura, A; Nasu, Y; Sako, T; Sugimoto, M; Watanabe, M, 2013
)
0.39
" We herein conducted a dose-response analysis of TRT in 160 patients with female to male GID."( Testosterone replacement elevates the serum uric acid levels in patients with female to male gender identity disorder.
Araki, M; Ariyoshi, Y; Ishii, K; Kumon, H; Kurahashi, H; Mahmood, S; Nagai, A; Nasu, Y; Sugimoto, M; Watanabe, M, 2013
)
0.39
" Its potential should be evaluated further by varying the dosage and treatment duration."( Effects of annatto-derived tocotrienol supplementation on osteoporosis induced by testosterone deficiency in rats.
Chin, KY; Ima-Nirwana, S, 2014
)
0.4
" The present study evaluated the effects of testosterone administration on the volume of liver, spleen and kidneys in a dose-response trial."( Effects of testosterone administration (and its 5-alpha-reduction) on parenchymal organ volumes in healthy young men: findings from a dose-response trial.
Aakil, A; Almeida, RR; Anderson, S; Basaria, S; Bhasin, S; Coleman, SL; Gagliano-Jucá, T; Huang, G; Jara, H; Li, Z; Melamud, K; Pencina, KM; Storer, TW; Tang, ER; Travison, TG, 2017
)
0.46
" Dosing was adjusted when indicated to 50 mg or 100 mg to maintain T trough levels between 350 and 650 ng/dL (12."( Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study.
Gittelman, M; Jaffe, JS; Kaminetsky, JC, 2019
)
0.81
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
androgenA 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]

Drug Classes (2)

ClassDescription
heptanoate esterAny fatty acid ester where the carboxylic acid component is heptanoic (also known as enanthic) acid.
sterol esterA steroid ester obtained by formal condensation of the carboxy group of any carboxylic acid with the 3-hydroxy group of a sterol.
[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]

Bioassays (9)

Assay IDTitleYearJournalArticle
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (523)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990153 (29.25)18.7374
1990's127 (24.28)18.2507
2000's114 (21.80)29.6817
2010's113 (21.61)24.3611
2020's16 (3.06)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 71.66

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index71.66 (24.57)
Research Supply Index6.57 (2.92)
Research Growth Index4.47 (4.65)
Search Engine Demand Index179.83 (26.88)
Search Engine Supply Index2.84 (0.95)

This Compound (71.66)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials143 (25.09%)5.53%
Reviews29 (5.09%)6.00%
Case Studies58 (10.18%)4.05%
Observational0 (0.00%)0.25%
Other340 (59.65%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (219)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 44 participants (Actual)Interventional2010-09-30Terminated
A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair [NCT04345666]Phase 2/Phase 30 participants (Actual)Interventional2021-08-31Withdrawn(stopped due to Unable to obtain funding to complete the study)
Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer. [NCT01122342]Phase 1/Phase 230 participants (Anticipated)Interventional2006-12-31Suspended(stopped due to Evaluating outcomes of current subjects pre further enrollment/dose reduction.)
Bipolar Androgen Therapy Plus Olaparib in Patient With Castration-Resistant Prostate Cancer [NCT03516812]Phase 236 participants (Actual)Interventional2018-08-29Active, not recruiting
Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients [NCT02990533]Phase 180 participants (Actual)Interventional2016-09-30Active, not recruiting
Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men [NCT03091348]Phase 44 participants (Actual)Interventional2017-08-29Completed
Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study. [NCT01291212]104 participants (Actual)Interventional2011-01-31Active, not recruiting
Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study [NCT04731376]Phase 1100 participants (Anticipated)Interventional2021-01-25Recruiting
Androgen Treatment in Leydig Cell Proliferation [NCT01206270]Phase 2/Phase 356 participants (Actual)Interventional2009-06-30Completed
Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW [NCT03768258]1,268 participants (Actual)Observational2008-03-31Completed
Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD [NCT03674320]Phase 2/Phase 30 participants (Actual)Interventional2021-12-01Withdrawn(stopped due to No Funding)
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 116 participants (Actual)Interventional2010-02-28Terminated
Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents [NCT02679274]Early Phase 13 participants (Actual)Interventional2016-02-16Terminated(stopped due to Lack of funding.)
Patient Satisfaction After Switching to Oral Testosterone Undecanoate in Men Currently on Testosterone Therapy [NCT04983940]Phase 441 participants (Actual)Interventional2021-06-18Completed
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 256 participants (Actual)Interventional2019-08-27Completed
Effects of Fast Acting Testosterone Nasal Spray on Anxiety [NCT02361190]96 participants (Actual)Interventional2015-02-28Completed
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 [NCT03792321]Phase 455 participants (Actual)Interventional2014-01-10Completed
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 4117 participants (Actual)Interventional2016-10-31Completed
Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study [NCT05649605]70 participants (Anticipated)Interventional2023-03-07Recruiting
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 4130 participants (Actual)Interventional2008-08-31Completed
Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism [NCT04798469]Phase 2150 participants (Anticipated)Interventional2022-01-10Recruiting
Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT02445716]Phase 270 participants (Anticipated)Interventional2015-10-31Recruiting
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 2350 participants (Actual)Interventional2003-10-31Completed
Mechanisms of Hormonal Control of Spermatogenesis in Man [NCT02147964]Phase 20 participants (Actual)Interventional2019-06-30Withdrawn(stopped due to No funding was obtained for this study.)
Feasibility Study of Post-hospitalization Interventions to Improve Physical Function [NCT02203656]Phase 1113 participants (Actual)Interventional2013-10-31Completed
A Randomized Phase I Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer [NCT01187485]Phase 115 participants (Actual)Interventional2004-06-30Completed
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 3626 participants (Actual)Interventional2010-10-31Completed
Effects of Testosterone on Myocardial Repolarization in Patients With Hypogonadism With/Without Chronic Heat Failure (NYHA Class I-II) [NCT03126656]Phase 4123 participants (Actual)Interventional2016-09-30Completed
Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism [NCT05541172]27 participants (Anticipated)Observational2022-03-01Recruiting
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 146 participants (Actual)Interventional2015-11-20Completed
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 162 participants (Actual)Interventional2010-05-31Completed
Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome [NCT01160341]Phase 4312 participants (Actual)Interventional2009-08-31Completed
Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue [NCT03379012]Phase 260 participants (Actual)Interventional2016-02-08Completed
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 10 participants (Actual)Interventional2017-07-31Withdrawn(stopped due to Study has been cancelled and it has not been initiated.)
Effect of Dose Fractionation of Testosterone Cypionate on Hematocrit in Transgender Men With Erythrocytosis Secondary to Testosterone Use. [NCT05487794]40 participants (Anticipated)Interventional2022-09-01Recruiting
Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study [NCT03339635]Phase 240 participants (Anticipated)Interventional2018-12-21Active, not recruiting
The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans With Spinal Cord Injury [NCT06130449]Early Phase 115 participants (Anticipated)Interventional2024-04-01Not yet recruiting
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? [NCT05964920]Phase 2/Phase 340 participants (Anticipated)Interventional2024-01-01Not yet recruiting
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 3228 participants (Anticipated)Interventional2018-07-16Not yet recruiting
Prospective Biomarker Analysis of Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Undergoing Bipolar Androgen Therapy (BAT) [NCT04424654]Phase 220 participants (Actual)Interventional2020-09-22Completed
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 226 participants (Anticipated)Interventional2023-11-30Not 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 2150 participants (Anticipated)Interventional2020-08-19Recruiting
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men [NCT03868059]Phase 3138 participants (Actual)Interventional2018-04-30Completed
Phase IV: Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism [NCT01084369]Phase 422 participants (Actual)Interventional2013-10-11Terminated(stopped due to Withdrawal of sponsorship)
Testosterone Replacement Therapy in Chronic Spinal Cord Injury [NCT00266864]Phase 2/Phase 331 participants (Actual)Interventional2003-08-31Completed
Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men [NCT00799617]Phase 3790 participants (Actual)Interventional2009-11-30Completed
Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels [NCT00613782]Phase 2/Phase 388 participants (Actual)Interventional2009-01-31Completed
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 432 participants (Anticipated)Interventional2022-01-25Recruiting
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 250 participants (Anticipated)Interventional2023-10-04Recruiting
Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction. [NCT02803073]Phase 2/Phase 30 participants (Actual)Interventional2016-08-31Withdrawn(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 40 participants (Actual)Interventional2023-01-01Withdrawn(stopped due to They study lost funding and decided to close the study down.)
Testosterone Supplementation in Men With MCI [NCT00539305]Phase 322 participants (Actual)Interventional2009-07-31Completed
Phase II Trial of Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer [NCT00853697]Phase 26 participants (Actual)Interventional2009-03-31Completed
Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use [NCT04895306]Phase 240 participants (Anticipated)Interventional2022-04-30Recruiting
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 168 participants (Actual)Interventional2007-06-30Completed
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 266 participants (Actual)Interventional2016-06-30Completed
Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men [NCT00695110]Phase 229 participants (Actual)Interventional2008-06-30Completed
The Effect of Male Hormonal Contraceptive Regimens on Prostate Tissue In Normal Men [NCT00490555]Phase 2/Phase 332 participants (Actual)Interventional2009-01-31Completed
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 128 participants (Actual)Interventional2008-01-31Completed
Compromised Microcirculation in Women With Polycystic Ovary Syndrome [NCT00757185]Early Phase 128 participants (Actual)Interventional2008-02-29Completed
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [NCT00957801]Phase 429 participants (Actual)Interventional2009-03-31Completed
Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill: a Randomised Double Blind Clinical Trial [NCT05825092]Phase 2600 participants (Anticipated)Interventional2023-07-21Recruiting
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer [NCT06145399]Early Phase 110 participants (Anticipated)Interventional2023-10-24Recruiting
Nutrition and Anabolic Interventions in Squamous Cell Carcinoma [NCT00878995]Phase 128 participants (Actual)Interventional2009-06-03Completed
Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01) [NCT00848497]Early Phase 13 participants (Actual)Interventional2007-11-30Terminated(stopped due to Lack of volunteers who would consent to participate and lack of funding)
High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer [NCT03522064]Phase 230 participants (Anticipated)Interventional2018-07-30Recruiting
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men [NCT02081300]Phase 3315 participants (Actual)Interventional2014-02-28Completed
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203 [NCT01386567]Phase 248 participants (Actual)Interventional2011-07-31Completed
Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men [NCT04134130]33 participants (Actual)Interventional2019-09-16Completed
The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men [NCT00700024]Phase 460 participants (Anticipated)Interventional2008-04-30Active, 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 1110 participants (Actual)Interventional2007-07-31Completed
COMbination of Bipolar Androgen Therapy and Nivolumab in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03554317]Phase 253 participants (Actual)Interventional2018-09-05Completed
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 231 participants (Actual)Interventional2008-12-31Completed
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 260 participants (Actual)Interventional2008-07-31Completed
Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer [NCT04049331]Phase 2240 participants (Anticipated)Interventional2021-03-22Recruiting
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 130 participants (Actual)Interventional2007-11-30Completed
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 3531 participants (Actual)Interventional2006-03-31Completed
Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease [NCT00239590]Phase 228 participants (Actual)Interventional2001-06-30Completed
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 113 participants (Actual)Interventional2018-07-15Completed
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 481 participants (Actual)Interventional2020-08-07Completed
Pilot Open Study of Testosterone Replacement in Non-alcoholic Steatohepatitis [NCT01919294]Phase 23 participants (Actual)Interventional2013-07-31Completed
Androgen Regulation of Priapism in Sickle Cell Disease [NCT01940718]Early Phase 10 participants (Actual)Interventional2014-03-31Withdrawn(stopped due to Funding could not be secured)
Clinical Trial of Androgen Effects on the Reproductive Neuroendocrine Axis [NCT04321551]Phase 440 participants (Anticipated)Interventional2023-07-01Not yet recruiting
Double-Blind, Placebo Controlled Randomized Study of Co-Administering Testosterone With PDE5 Inhibitors in Patients Non-Responders to PDE5 Inhibitors Alone [NCT00244023]Phase 3173 participants (Actual)Interventional2005-10-31Completed
A Pilot Study in Healthy Male Volunteers to Evaluate a Skeletal-Muscle Microbiopsy Technique for Suitability of Use With Dynamic Proteomic Measurement [NCT01962454]Phase 120 participants (Actual)Interventional2014-05-05Completed
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 220 participants (Actual)Interventional2006-11-30Completed
A Preliminary Trial of Testosterone Replacement for Fatigue in Male Hypogonadic Patients With Advanced Cancer. [NCT00965341]Phase 353 participants (Actual)Interventional2009-09-30Completed
Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women [NCT02215434]Phase 260 participants (Actual)Interventional2009-09-30Completed
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 316 participants (Actual)Interventional2008-11-04Completed
Testosterone and Alendronate in Hypogonadal Men [NCT01460654]Phase 244 participants (Actual)Interventional2011-10-31Terminated
Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience [NCT01601327]Phase 4119 participants (Actual)Interventional2008-01-31Completed
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)Observational2005-09-30Completed
Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption: Evaluation of Newly Developed Markers [NCT04166786]Phase 14 participants (Actual)Interventional2019-05-06Completed
Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation [NCT00675714]Phase 2/Phase 31,126 participants (Actual)Interventional2004-01-31Terminated(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.)
The Effects of Cyclic Testosterone Administration on Muscle Function in Older Individuals [NCT00957528]Phase 126 participants (Actual)Interventional2006-01-31Completed
The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men [NCT01417364]Phase 40 participants (Actual)Interventional2016-01-31Withdrawn(stopped due to Unable to identify any qualifying subjects willing to enroll into this study.)
The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1) [NCT00161486]Phase 113 participants (Actual)Interventional2004-07-31Completed
The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa [NCT00853502]Phase 20 participants (Actual)Interventional2008-12-31Withdrawn(stopped due to No recruitment)
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 3250 participants (Anticipated)Interventional2005-10-31Recruiting
Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application [NCT00705796]Phase 10 participants (Actual)InterventionalWithdrawn(stopped due to financial constraints)
Locomotor Training With Testosterone to Promote Bone and Muscle Health [NCT04460872]Phase 221 participants (Anticipated)Interventional2021-01-31Recruiting
Salivary Testosterone in Men: Diurnal Variation and Post-prandial Responses [NCT04326673]40 participants (Actual)Observational2020-10-30Active, not recruiting
Study of Testosterone and rHGH in FSHD (STARFISH): A Proof-of-Concept Study [NCT03123913]Phase 120 participants (Actual)Interventional2017-12-18Completed
Exercise Training and Testosterone Replacement in Heart Failure Patients [NCT01852994]Phase 439 participants (Actual)Interventional2009-07-31Completed
The Effects of Natesto For Treatment Of Hypogonadism On Maintenance Of Spermatogensis. [NCT04717362]Early Phase 140 participants (Anticipated)Interventional2024-03-01Not 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 332 participants (Actual)Interventional2014-03-31Completed
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women [NCT01724658]Phase 270 participants (Actual)Interventional2012-06-30Completed
Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men [NCT00452322]Phase 260 participants Interventional1997-04-30Completed
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 430 participants (Actual)Interventional2007-01-31Completed
Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome [NCT00487734]Phase 419 participants (Actual)Interventional2007-08-31Completed
Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers. [NCT04757532]Phase 19 participants (Actual)Interventional2020-12-03Completed
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 422 participants (Actual)Interventional2011-03-31Completed
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV. [NCT00555087]Phase 450 participants (Anticipated)Interventional2007-05-31Recruiting
The Role of 5-Alpha Reductase in Mediating Testosterone Actions [NCT00070733]Phase 3184 participants Interventional2003-08-31Recruiting
Testosterone and Physical Function in HIV Associate Weight Loss [NCT00260143]Phase 261 participants (Actual)Interventional2003-05-31Completed
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 160 participants (Actual)Interventional2006-10-31Completed
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 2322 participants (Actual)Interventional2001-11-30Completed
The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly [NCT00117000]Phase 3200 participants Interventional2003-07-31Active, not recruiting
[NCT00119483]200 participants Interventional2005-09-30Completed
The Role of 5-alpha Reductase in Mediating Testosterone Actions [NCT00493987]Phase 4184 participants (Anticipated)Interventional2002-11-30Completed
Muscle Strength and -Mass After Bariatric Surgery - a Possible Effect of Testosterone Replacement Therapy? Randomized, Placebo-controlled and Double-blinded Study [NCT03721497]Phase 450 participants (Anticipated)Interventional2020-12-17Recruiting
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 2350 participants Interventional2004-06-30Completed
Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men) [NCT00161304]Phase 2/Phase 344 participants (Actual)Interventional2003-04-30Completed
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women [NCT00141557]Phase 2133 participants (Actual)Interventional2004-07-31Terminated(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 215 participants (Actual)Interventional2009-07-31Completed
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 216 participants (Actual)Interventional2009-07-31Completed
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 396 participants (Actual)Interventional2003-02-28Completed
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 2150 participants (Actual)Interventional2005-07-31Terminated(stopped due to Recruitment issues)
Regulation of Cortisol Metabolism and Fat Patterning [NCT00694733]140 participants (Actual)Interventional2005-05-31Active, 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 362 participants (Actual)Interventional2011-10-31Completed
A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients [NCT01516554]Phase 23 participants (Actual)Interventional2012-02-29Terminated(stopped due to Poor recruitment)
IGF-1 and Bone Loss in Women Anorexia Nervosa [NCT00089843]Phase 2/Phase 377 participants (Actual)Interventional2003-06-30Completed
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 280 participants InterventionalCompleted
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 228 participants (Actual)Interventional2004-07-31Terminated(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)Observational2007-06-30Completed
A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease [NCT00392912]10 participants (Actual)Interventional2007-04-30Completed
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 243 participants (Actual)Interventional2006-10-31Completed
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 125 participants (Actual)Interventional2016-11-03Completed
Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals) [NCT00146146]Phase 315 participants (Actual)Interventional2005-05-31Completed
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 21,251 participants (Anticipated)Interventional2005-06-30Completed
Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial [NCT00405353]Phase 1/Phase 210 participants (Actual)Interventional2002-04-30Completed
5-Alpha Reductase and Anabolic Effects of Testosterone [NCT00475501]Phase 260 participants (Actual)Interventional2007-01-31Completed
Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism [NCT00663793]Phase 116 participants (Actual)Interventional2008-10-31Completed
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 276 participants (Actual)Interventional2007-03-31Completed
A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer [NCT02286921]Phase 2222 participants (Actual)Interventional2015-01-31Completed
Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical Disabilities [NCT02990507]40 participants (Actual)Interventional2017-02-10Completed
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment [NCT02408445]Phase 420 participants (Actual)Interventional2015-05-08Completed
Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury [NCT01652040]Phase 2/Phase 326 participants (Actual)Interventional2012-07-02Completed
A Phase II Study of Bipolar Androgen-based Therapy for Men With Androgen Ablation NaÃ-ve Recurrent Prostate Cancer [NCT01750398]Phase 233 participants (Actual)Interventional2013-01-31Completed
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 230 participants (Anticipated)Interventional2023-12-01Not yet recruiting
SPECTRA: SupraPhysiological Androgen to Enhance Chemotherapy TReatment Activity [NCT06039371]Phase 246 participants (Anticipated)Interventional2024-01-01Not 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)Observational2006-10-31Completed
Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion. [NCT00230984]Phase 3200 participants Interventional2003-04-30Completed
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 2180 participants (Anticipated)Interventional2012-07-01Recruiting
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men [NCT01252745]Phase 222 participants (Actual)Interventional2010-08-31Completed
Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate [NCT01758029]80 participants (Anticipated)Observational2013-01-31Not yet recruiting
A Randomized and Double-blind Study to Evaluate the Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects [NCT01813201]Phase 414 participants (Actual)Interventional2011-03-31Completed
Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men [NCT01143818]1,053 participants (Actual)Observational2007-12-31Completed
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 230 participants (Anticipated)Interventional2022-03-07Recruiting
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY [NCT03325647]Phase 472 participants (Actual)Interventional2017-11-06Completed
Collaborative Study: Testosterone Antidepressant Augmentation in Women [NCT01783574]101 participants (Actual)Interventional2013-08-31Completed
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men [NCT01686828]Phase 1/Phase 253 participants (Actual)Interventional2013-06-30Completed
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial [NCT05722301]Phase 30 participants (Actual)Interventional2019-11-01Withdrawn(stopped due to Study was never initiated.)
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 3306 participants (Actual)Interventional2011-09-30Completed
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 260 participants (Actual)Interventional2011-06-30Completed
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical [NCT04342247]30 participants (Actual)Observational2019-01-01Completed
Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men. [NCT03242590]Phase 395 participants (Actual)Interventional2016-12-31Completed
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer [NCT01084759]16 participants (Actual)Interventional2010-03-31Completed
A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy [NCT02229617]Phase 1/Phase 214 participants (Actual)Interventional2015-07-31Completed
An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels [NCT01364623]Phase 124 participants (Actual)Interventional2011-09-30Completed
A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II) [NCT04120363]Phase 434 participants (Actual)Interventional2019-09-23Completed
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 4140 participants (Actual)Interventional2008-09-30Completed
CYP19A1 Gene and Pharmacogenetics of Response [NCT01378299]Phase 1105 participants (Actual)Interventional2011-10-01Completed
Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) [NCT04558866]Phase 251 participants (Actual)Interventional2021-04-30Active, not recruiting
Hormones and Decision Making [NCT04865562]Phase 430 participants (Actual)Interventional2015-03-01Completed
Will Testosterone and Growth Hormone Improve Bone Structure? [NCT00080483]Phase 235 participants (Actual)Interventional2004-03-31Completed
Testosterone Supplementation and Exercise in Elderly Men [NCT00112151]Phase 2167 participants (Actual)Interventional2005-01-31Completed
A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism [NCT02504541]Phase 3133 participants (Actual)Interventional2015-07-31Completed
The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery [NCT01595581]Phase 314 participants (Actual)Interventional2012-04-30Completed
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 218 participants (Actual)Interventional2016-10-31Completed
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 175 participants (Actual)Interventional2013-05-23Completed
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 4676 participants (Actual)Interventional2020-06-30Completed
Effect of Transgender Therapy on Hormone Receptors, Adipogenesis, Myogenesis and Inflammation [NCT04551144]4 participants (Actual)Observational2020-10-06Active, not recruiting
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT01403116]Phase 3325 participants (Actual)Interventional2011-07-31Completed
Testosterone and Long Pulse Width Stimulation for Denervated Muscles After Spinal Cord Injury [NCT03345576]Phase 212 participants (Actual)Interventional2018-07-01Completed
Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters [NCT03203681]Phase 460 participants (Actual)Interventional2017-10-27Completed
Randomized Control Trial of Long Acting Subcutaneous Testosterone Pellets for Hypogonadism: Testopel ® vs. Generic Testosterone Pellets. [NCT04523480]Phase 375 participants (Actual)Interventional2020-03-12Completed
Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury [NCT03576001]Phase 288 participants (Anticipated)Interventional2019-08-23Recruiting
Phase IIa, Pilot, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men [NCT02697188]Phase 212 participants (Actual)Interventional2007-11-30Completed
Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men [NCT02670343]Phase 1/Phase 28 participants (Actual)Interventional2016-01-31Completed
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial [NCT02734238]Phase 453 participants (Actual)Interventional2016-04-30Completed
Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters. [NCT04336891]81 participants (Actual)Observational2019-03-20Completed
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men. [NCT03242408]Phase 3100 participants (Actual)Interventional2017-01-31Completed
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis [NCT03910738]Phase 240 participants (Anticipated)Interventional2019-10-29Recruiting
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 330 participants (Anticipated)Interventional2016-10-31Recruiting
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 144 participants (Actual)Interventional2015-04-30Completed
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence [NCT03116087]60 participants (Actual)Interventional2007-03-01Completed
An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects [NCT02233751]Phase 112 participants (Actual)Interventional2014-09-30Completed
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 30 participants (Actual)Interventional2021-01-01Withdrawn(stopped due to Lack of funds)
Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI [NCT02248701]Phase 233 participants (Actual)Interventional2017-04-27Terminated(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 13 participants (Actual)Interventional2017-02-09Terminated(stopped due to lack of accrual)
Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT01699178]Phase 3182 participants (Actual)Interventional2012-08-31Completed
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency [NCT03716739]Phase 2142 participants (Anticipated)Interventional2019-03-19Recruiting
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women [NCT03314298]Phase 111 participants (Actual)Interventional2017-08-14Completed
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel [NCT01893281]Phase 478 participants (Actual)Interventional2013-07-31Completed
Optimizing Protein Intake in Older Americans With Mobility Limitations [NCT01275365]Phase 392 participants (Actual)Interventional2011-05-31Completed
Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men [NCT01765179]Phase 3144 participants (Actual)Interventional2013-01-31Completed
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 3715 participants (Actual)Interventional2013-05-31Completed
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT02722278]Phase 3222 participants (Actual)Interventional2016-03-31Completed
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 230 participants (Anticipated)Interventional2024-05-31Not yet recruiting
Clinical Effect of Follicular Preparation With Testosterone in Poor Ovarian Response: a Randomized Controlled Clinical Trial (TESTOPRIM) [NCT03378713]Phase 363 participants (Actual)Interventional2017-08-07Completed
Hormonal Mechanisms of Sleep Restriction [NCT02256865]Early Phase 140 participants (Actual)Interventional2014-10-31Completed
Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism [NCT00350701]Phase 449 participants (Actual)Interventional2006-07-31Completed
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 2112 participants (Actual)Interventional2014-08-25Completed
Cardiovascular Consequences of Hypogonadism in Men [NCT02758431]379 participants (Anticipated)Interventional2016-07-01Active, 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 3107 participants (Actual)Interventional2013-07-04Completed
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 239 participants (Actual)Interventional2013-09-30Completed
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 3150 participants (Actual)Interventional2014-07-31Completed
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome [NCT04327934]Early Phase 122 participants (Actual)Interventional2017-12-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
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]Bone Mineral Density
NCT00089843 (2) [back to overview]Markers of Bone Metabolism
NCT00112151 (6) [back to overview]Lower Body Muscle Strength (1-RM, kg)
NCT00112151 (6) [back to overview]Fat Mass (kg)
NCT00112151 (6) [back to overview]Fat Free Mass (kg)
NCT00112151 (6) [back to overview]Upper Body Muscle Strength (1-RM, kg)
NCT00112151 (6) [back to overview]Power (Power Rig, Watts)
NCT00112151 (6) [back to overview]Physical Function (CS-PFP Total Score)
NCT00239590 (2) [back to overview]Myocardial Perfusion
NCT00239590 (2) [back to overview]Endothelial Function
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)
NCT00350701 (3) [back to overview]Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
NCT00350701 (3) [back to overview]Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
NCT00350701 (3) [back to overview]Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
NCT00405353 (1) [back to overview]Whole Brain Atrophy Rate
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 Clinical Success During the 3rd 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]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 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]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 Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]Change in Weight From Baseline to Week 24 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]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]Trough Assessments of Serum Total Testosterone Concentrations in Part C2
NCT00467870 (35) [back to overview]Serum Total Testosterone Concentrations in Part C2
NCT00467870 (35) [back to overview]Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2
NCT00467870 (35) [back to overview]Serum Total Testosterone Maximum Concentration in Part B
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]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]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
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 3rd Injection Interval in Part C
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]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 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 Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During 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 4th 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]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 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
NCT00475501 (11) [back to overview]Dietary Protein Intake
NCT00475501 (11) [back to overview]Benton Judgment of Line Orientation Test
NCT00475501 (11) [back to overview]30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test
NCT00475501 (11) [back to overview]1 Repetition Maximum (1-RM) Strength Testing
NCT00475501 (11) [back to overview]Life Satisfaction
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]Lumbar Spine L2-L4 Bone Mineral Density
NCT00475501 (11) [back to overview]Geriatric Depression Scale
NCT00475501 (11) [back to overview]Hematocrit
NCT00475501 (11) [back to overview]Grip Strength kg
NCT00490555 (5) [back to overview]Prostate-specific Antigen (PSA)
NCT00490555 (5) [back to overview]Testosterone Concentration
NCT00490555 (5) [back to overview]Dihydrotestosterone (DHT) Concentration
NCT00490555 (5) [back to overview]Dehydroepiandrosterone (DHEA)
NCT00490555 (5) [back to overview]Androstenedione (AED)
NCT00539305 (4) [back to overview]Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test
NCT00539305 (4) [back to overview]Short-Form Health Survey (SF-36)
NCT00539305 (4) [back to overview]Geriatric Depression Scale (GDS)
NCT00539305 (4) [back to overview]Behavioral & Mood Measure: Profile of Mood States (POMS)
NCT00663793 (3) [back to overview]Area Under the Curve-E2
NCT00663793 (3) [back to overview]Area Under the Curve-Serum T
NCT00663793 (3) [back to overview]Area Under the Curve-serum DHT
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)
NCT00695110 (4) [back to overview]Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
NCT00698035 (7) [back to overview]Sexual Satisfaction
NCT00698035 (7) [back to overview]Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
NCT00698035 (7) [back to overview]Change in Vaginal Epithelium Scores
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]Sexual Quality of Life
NCT00698035 (7) [back to overview]Total Testosterone Levels
NCT00729859 (10) [back to overview]Luteinizing Hormone Concentration (LH)
NCT00729859 (10) [back to overview]Fasting Lipid Levels
NCT00729859 (10) [back to overview]Fasting Serum Insulin
NCT00729859 (10) [back to overview]Endothelial Progenitor Cells
NCT00729859 (10) [back to overview]Estradiol Concentration
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]Quantitative Insulin Sensitivity Check Index (QUICKI)
NCT00729859 (10) [back to overview]Sex Hormone Binding Globulin (SHBG)
NCT00729859 (10) [back to overview]Testosterone Concentration
NCT00755183 (2) [back to overview]Ocular Discomfort Score at Visit 4
NCT00755183 (2) [back to overview]Meibomian Gland Secretion Appearance at Visit 4 (Day 168)
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]Sexual Function Trial - Sexual Desire Domain
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]Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
NCT00799617 (37) [back to overview]Vitality Trial - SF-36 Score
NCT00799617 (37) [back to overview]Physical Function Trial - PF 10 Overall Score
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]Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)
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 Total Hip by Dual-energy X-ray Absorptiometry (DXA)
NCT00799617 (37) [back to overview]Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N
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]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)
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]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]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]Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume
NCT00848497 (4) [back to overview]Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
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 SHIM (Sexual Health Inventory for Males) Score at 6 Months After 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.
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]1-year Survival
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]Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline
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 1 Beta (IL-1B) 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 6 (IL-6) 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 7 (IL-7) 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 12 (IL-12) 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 8 (IL-8) 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]Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry 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]Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) 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]Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 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]Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 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 Isometric Leg Strength as Measured by Biodex Pro4 at Baseline
NCT00878995 (47) [back to overview]Mood as Measured by Profile of Mood States at 7 Weeks
NCT00878995 (47) [back to overview]Mood Measured by Profile of Mood States at Baseline
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]Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks
NCT00878995 (47) [back to overview]Physical Activity Levels as Measured by the ActiGraph Accelerometer
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]Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline
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 2 (IL-2) 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 4 (IL-4) 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 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.
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]Body Weight as Measured by Scale at 7 Weeks.
NCT00878995 (47) [back to overview]Body Weight as Measured by Scale at Baseline
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]Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) 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 Interferon-gamma (IFN Gamma) 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.
NCT00878995 (47) [back to overview]Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.
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]Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)
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 Serum Markers of Bone Turnover.
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 Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
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]Serum Total Testosterone Measured on Treatment Day 4
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]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]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]Triglycerides Measured on Treatment Day 1 (Baseline 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]Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post 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]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]Hematocrit 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]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline 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]Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline 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).
NCT01084759 (3) [back to overview]Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)
NCT01084759 (3) [back to overview]Time to PSA Progression
NCT01084759 (3) [back to overview]Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.
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
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
NCT01208038 (4) [back to overview]Insulin Resistance - HOMA-IR
NCT01208038 (4) [back to overview]Arterial Compliance - Augmentation Index
NCT01208038 (4) [back to overview]Endothelial Function
NCT01208038 (4) [back to overview]Libido - B-PFSF Score
NCT01252745 (3) [back to overview]AUC0-t of Serum Testosterone
NCT01252745 (3) [back to overview]Cmax of Serum Testosterone
NCT01252745 (3) [back to overview]Cavg of Serum Testosterone
NCT01275365 (10) [back to overview]Change of 50-meter Loaded Walking Test
NCT01275365 (10) [back to overview]Change of Psychological Well Being Index (PGWBI)
NCT01275365 (10) [back to overview]Change of Maximal Voluntary Strength
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 Derogatis Affective Balance Scale (DABS)
NCT01275365 (10) [back to overview]Change of Stair Climbing Tests
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 6-minute Walking Distance
NCT01275365 (10) [back to overview]Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
NCT01275365 (10) [back to overview]Change of Leg Press Power
NCT01327495 (14) [back to overview]DHEA
NCT01327495 (14) [back to overview]Androstenedione
NCT01327495 (14) [back to overview]Prostate Tissue DHT Concentrations After Treatment
NCT01327495 (14) [back to overview]Prostate Tissue Testosterone Concentrations After Treatment
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]Dihydrotestosterone (DHT)
NCT01327495 (14) [back to overview]Androsterone
NCT01327495 (14) [back to overview]17-OHPreg
NCT01327495 (14) [back to overview]17-OHP
NCT01327495 (14) [back to overview]Prostate Specific Antigen
NCT01364623 (5) [back to overview]Medium Dose TBS-2 Multiple Dose Average Steady-state Concentration (Cavg) of Total Testosterone
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 Estradiol 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 Dihydrotestosterone Following TBS-2
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 Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene
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 Aromatase Gene Activity From the Buffy Coat According to the 700518 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 Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene
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 Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene
NCT01378299 (12) [back to overview]Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus
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 the Presence of Diabetes Mellitus
NCT01378299 (12) [back to overview]Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene
NCT01386606 (7) [back to overview]Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
NCT01386606 (7) [back to overview]Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
NCT01386606 (7) [back to overview]Morning Testosterone Correlated With Serial Testosterone.
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]Change in Leuteinizing Hormone (LH)
NCT01386606 (7) [back to overview]Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
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
NCT01403116 (2) [back to overview]Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL
NCT01446042 (2) [back to overview]Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
NCT01446042 (2) [back to overview]Serum Testosterone Cavg
NCT01460654 (1) [back to overview]Percent Change in Spine Bone Density From Baseline to 12 Months
NCT01595581 (3) [back to overview]KOOS Scores
NCT01595581 (3) [back to overview]Strength
NCT01595581 (3) [back to overview]Changes in Lean Mass
NCT01652040 (2) [back to overview]Metabolic Profile
NCT01652040 (2) [back to overview]Body Composition
NCT01686828 (3) [back to overview]Changes in Body Composition
NCT01686828 (3) [back to overview]Insulin Sensitivity Quantified by Matsuda Index
NCT01686828 (3) [back to overview]Changes in Adipose Tissue Gene Expression
NCT01699178 (6) [back to overview]Absolute Change From Baseline in Hct
NCT01699178 (6) [back to overview]Absolute Change From Baseline in HDL
NCT01699178 (6) [back to overview]Absolute Change From Baseline in Hgb
NCT01699178 (6) [back to overview]Absolute Change From Baseline in LDL
NCT01699178 (6) [back to overview]Absolute Change From Baseline in Prostate Volume
NCT01699178 (6) [back to overview]Absolute Change From Baseline in T Cholesterol
NCT01750398 (7) [back to overview]Quality of Life Survey
NCT01750398 (7) [back to overview]Radiographic or Clinical Progression
NCT01750398 (7) [back to overview]Complete PSA Response
NCT01750398 (7) [back to overview]Change in C-telopeptides
NCT01750398 (7) [back to overview]Patients With PSA <4 ng/mL at the End of the Study
NCT01750398 (7) [back to overview]Change in Waist Circumference
NCT01750398 (7) [back to overview]Change in Weight
NCT01765179 (2) [back to overview]Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
NCT01765179 (2) [back to overview]Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
NCT01783574 (3) [back to overview]Depressive Symptom Severity
NCT01783574 (3) [back to overview]Fatigue
NCT01783574 (3) [back to overview]Sexual Dysfunction
NCT01816295 (5) [back to overview]Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores
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]Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
NCT01816295 (5) [back to overview]Change From Baseline in Total International Prostate Symptom Score (IPSS)
NCT01816295 (5) [back to overview]Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
NCT01887418 (4) [back to overview]Number of Patients in the PK Parameter Category
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]The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
NCT01887418 (4) [back to overview]The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
NCT01893281 (4) [back to overview]Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive
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
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
NCT02159469 (2) [back to overview]Safety and Tolerability
NCT02159469 (2) [back to overview]Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
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
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)
NCT02248701 (6) [back to overview]Percent Changes in Muscle Cross-Sectional Area
NCT02248701 (6) [back to overview]Percent Change in Visceral Fat
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]Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire
NCT02286921 (14) [back to overview]Quality of Life as Assessed by Short Form 36
NCT02286921 (14) [back to overview]Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)
NCT02286921 (14) [back to overview]Pain Interference as Assessed by the Brief Pain Inventory
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]Pain Severity as Assessed by the Brief Pain Inventory
NCT02286921 (14) [back to overview]Time to Prostate-Specific Antigen Progression
NCT02286921 (14) [back to overview]Radiographic Progression
NCT02286921 (14) [back to overview]Prostate-Specific Antigen Response Rate
NCT02286921 (14) [back to overview]Progression Free Survival on Crossover Treatment
NCT02286921 (14) [back to overview]Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression
NCT02286921 (14) [back to overview]Overall Survival
NCT02286921 (14) [back to overview]Objective Response Rate as Determined by RECIST
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
NCT02408445 (10) [back to overview]Serum Anti-Mullerian Hormone (AMH)
NCT02408445 (10) [back to overview]Serum Follicle Stimulating Hormone (FSH)
NCT02408445 (10) [back to overview]Serum Inhibin B (INHB)
NCT02408445 (10) [back to overview]Serum Luteinizing Hormone (LH)
NCT02408445 (10) [back to overview]Serum Total Testosterone
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
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
NCT02670343 (1) [back to overview]% of Mean Difference in T Concentration Compared to Plain Collection Tube
NCT02679274 (13) [back to overview]Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
NCT02679274 (13) [back to overview]Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline
NCT02679274 (13) [back to overview]Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)
NCT02679274 (13) [back to overview]Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB).
NCT02679274 (13) [back to overview]Change in Handgrip Strength
NCT02679274 (13) [back to overview]Change in Hip Abduction Strength (Supine)
NCT02679274 (13) [back to overview]Change in Knee Extension Strength (Seated)
NCT02679274 (13) [back to overview]Semi-Tandem 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]Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
NCT02679274 (13) [back to overview]Side by Side 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]Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
NCT02697188 (2) [back to overview]Mean Serum Dihydrotestosterone Cmax
NCT02697188 (2) [back to overview]Mean Serum Testosterone Cavg
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]Time Weighted Average Total Testosterone Concentration (Cavg-am)
NCT02921386 (4) [back to overview]Area Under the Curve (AUC-am)
NCT02921386 (4) [back to overview]Cmax-am for Oral TU Across Breakfast With Varying Fat Content
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 Total Testosterone Concentration
NCT03091348 (8) [back to overview]Change in Levels of Serum SHBG
NCT03091348 (8) [back to overview]Change in Levels of Serum LH
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
NCT03123913 (8) [back to overview]Mean Change in Level of Luteinizing Hormone 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 TSH in the Blood
NCT03123913 (8) [back to overview]Mean Change in Total Lean Body Mass
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 FSH in the Blood
NCT03123913 (8) [back to overview]Number of Participants Who Experienced an AE
NCT03123913 (8) [back to overview]Mean Change in Level of IGF-1 in the Blood
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 Estradiol Levels From Baseline to 27 Weeks
NCT03203681 (6) [back to overview]Change in Sperm Counts From Baseline to 27 Weeks
NCT03203681 (6) [back to overview]Change in Testosterone Levels From Baseline to 27 Weeks
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]Safety of Bipolar Androgen Therapy + Nivolumab As Determined by the Number of CTCAEs ≥ Grade 3
NCT03554317 (7) [back to overview]PSA Progression-Free Survival (PSA-PFS) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]Progression-Free Survival (PFS) to Bipolar Androgen Therapy + Nivolumab
NCT03554317 (7) [back to overview]Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab
NCT03868059 (26) [back to overview]Change in ABPM-measured Average Nighttime 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 24-hour Pulse Rate (PR)
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 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 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]Change in ABPM-measured Average Nighttime SBP
NCT03868059 (26) [back to overview]Change in Patient Reported Sexual Desire
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]Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
NCT03868059 (26) [back to overview]Change in Hematocrit From Baseline
NCT03868059 (26) [back to overview]Change in Hemoglobin From Baseline
NCT03868059 (26) [back to overview]Change in Morning DBP Measured in Triplicate at the Clinic
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 is SBP Dip
NCT03868059 (26) [back to overview]Change in Patient Reported Sexual Distress
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]Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
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]Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
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
NCT04120363 (6) [back to overview]Wingate Peak Power
NCT04134091 (13) [back to overview]Relative Change in Appendicular Lean Muscle Mass
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]Number of Subjects With Improvement in Fibrosis Evaluated Via FibroNest Scores
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 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]Relative Change in Whole Body Fat Mass
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]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]Number of Participants With Resolution of NASH on Overall Histopathological Reading 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]Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]Relative Change in MRI-PDFF Measurements 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.
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 Testosterone (T) Levels
NCT04523480 (4) [back to overview]Change in PSA Levels
NCT04523480 (4) [back to overview]Change in Hematocrit (Hct) Levels.
NCT04523480 (4) [back to overview]Change in Estradiol Levels
NCT04983940 (6) [back to overview]Serum Estradiol 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]Hypogonadal Symptoms as Measured by qADAM Questionnaire
NCT04983940 (6) [back to overview]Hematocrit Levels
NCT04983940 (6) [back to overview]Serum Testosterone Levels

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

,
Interventionunitless (Mean)
baselineone yeartwo years
1 The Effects of Testosterone Combined With G0.1120.1190.123
2 The Effects of Testosterone Alone on Structural and Mechanic0.1040.1110.114

[back to top]

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

Interventionpercent change (Mean)
Actonel (Risedronate) 35 mg Weekly3.2
Testosterone-0.6

[back to top]

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

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

[back to top]

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

Interventionkg (Mean)
Placebo + No PRT9.4
Placebo + PRT27.0
Any T + No PRT10.5
Any T + PRT28.0

[back to top]

Fat Mass (kg)

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

Interventionkg (Mean)
Placebo + No PRT0.7
Placebo + PRT-0.6
Any T + No PRT-1.0
Any T + PRT-1.8

[back to top]

Fat Free Mass (kg)

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

Interventionkg (Mean)
Placebo + No PRT0.1
Placebo + PRT0.4
Any T + No PRT1.0
Any T + PRT2.1

[back to top]

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

Interventionkg (Mean)
Placebo + No PRT4.3
Placebo + PRT25.5
Any T + No PRT7.8
Any T + PRT24.3

[back to top]

Power (Power Rig, Watts)

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

InterventionWatts (Mean)
Placebo + No PRT4.5
Placebo + PRT24.3
Any T + No PRT0.8
Any T + PRT5.1

[back to top]

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

Interventionunits on a scale (Mean)
Placebo + No PRT3.1
Placebo + PRT3.6
Any T + No PRT0.8
Any T + PRT3.3

[back to top]

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)

Interventionmyocardial perfusion index (Mean)
Testosterone1.83
Placebo1.52

[back to top]

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)

InterventionAugmentation index (Mean)
Testosterone76.5
Placebo79.4

[back to top]

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

Interventionkcal/day (Mean)
Testosterone Replacement Therapy1440
No Intervention1339

[back to top]

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

Interventionkilograms (Mean)
Testosterone Replacement Therapy53.1
No Intervention50.5

[back to top]

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

,,
InterventionPercent change from baseline (Mean)
baseline8 week
Androgel 10g10082
Androgel 5g100236
Placebo100100

[back to top]

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

,,
Interventionpercentage of baseline value (Mean)
baseline8 week
Androgel 10g100125
Androgel 5g10091
Placebo100110

[back to top]

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

,,
Interventionpercentage of baseline value (Mean)
baseline8 week
Androgel 10g100130
Androgel 5g10068
Placebo10095

[back to top]

Whole Brain Atrophy Rate

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

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

[back to top]

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

Interventionpercentage of participants (Number)
Cmax >1000 ng/dLCmax >1100 ng/dLCmax >1250 ng/dLCmax <300 or >1000 ng/dL
C2-TU 750 mg8.74.34.360.9

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg53.8

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg96.2

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg37.5

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg51.3

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg96.2

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg94.0

[back to top]

Change in Weight From Baseline to Week 24 in Part C

(NCT00467870)
Timeframe: Baseline, Week 24

Interventionkg (Mean)
C-TU 750 mg0.06

[back to top]

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

Interventionkg/m2 (Mean)
C-TU 750 mg0.023

[back to top]

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

Interventionpercentage of participants (Number)
Cmax ≤1500 ng/dLCmax >1500 to <1800 ng/dLCmax 1800 to 2500 ng/dLCmax >2500 ng/dL
C-TU 750 mg92.33.83.80

[back to top]

Trough Assessments of Serum Total Testosterone Concentrations in Part C2

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

Interventionng/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 mg197.629210.363254.669317.419316.215374.698375.797

[back to top]

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

Interventionng/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 mg197.629210.363254.669578.419606.484580.614545.236317.419316.215374.698375.797

[back to top]

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

Interventionpg/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 mg180.33301.85322.74332.92324.74230.71

[back to top]

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

Interventionng/dL (Mean)
B-TU 750 mg986.364
B-TU 1000 mg1047.739

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg94.9

[back to top]

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

Interventionng/dL (Mean)
C2-TU 750 mg317.419

[back to top]

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

Interventionng/dL (Mean)
C2-TU 750 mg449.6455

[back to top]

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

Interventionng/dL (Mean)
C-TU 750 mg494.9373

[back to top]

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

Interventionng/dL (Mean)
C-TU 750 mg514.2792

[back to top]

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

Interventionng/dL (Mean)
C-TU 750 mg323.522

[back to top]

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

Interventionng/dL (Mean)
C-TU 750 mg342.800

[back to top]

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

Interventionng/dL (Mean)
C2-TU 750 mg689.002

[back to top]

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

Interventionng/dL (Mean)
C-TU 750 mg890.583

[back to top]

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

Interventionng/dL (Mean)
C-TU 750 mg837.648

[back to top]

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

Interventionng/dL (Mean)
A-TU 750 mg805.867
A-TU 1000 mg1023.591

[back to top]

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

Interventionng/dL (Mean)
C2-TU 750 mg711.343

[back to top]

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

Interventiondays (Mean)
C-TU 750 mg50.2

[back to top]

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

Interventionpercentage of participants (Number)
Screening, <300 ng/dLScreening, >1000 ng/dLDay 0, <300 ng/dLDay 0, >1000 ng/dLDay 0 at Week 4, <300 ng/dLDay 0 at Week 4, >1000 ng/dLDay 4 post injection at Week 4, <300 ng/dLDay 4 post injection at Week 4, >1000 ng/dLDay 7 post injection at Week 4, <300 ng/dLDay 7 post injection at Week 4, >1000 ng/dLDay 11 post injection at Week 4, <300 ng/dLDay 11 post injection at Week 4, >1000 ng/dLDay 14 post injection at Week 4, <300 ng/dLDay 14 post injection at Week 4, >1000 ng/dLWeek 14, <300 ng/dLWeek 14, >1000 ng/dLWeek 24, <300 ng/dLWeek 24, >1000 ng/dLWeek 34, <300 ng/dLWeek 34, >1000 ng/dLWeek 44, <300 ng/dLWeek 44, >1000 ng/dL
C2-TU 750 mg100.0091.3078.3015.05.009.104.504.852.2047.8036.4035.00

[back to top]

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

Interventiondays (Mean)
C-TU 750 mg60.6

[back to top]

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

Interventionpercentage of participants (Number)
Cmax ≤1500 ng/dLCmax 1800-2500 ng/dLCmax >2500 ng/dL
C2-TU 750 mg95.700

[back to top]

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

Interventionpercentage of participants (Number)
Cmax ≤1500 ng/dLCmax 1800-2500 ng/dLCmax >2500 ng/dL
C-TU 750 mg92.300

[back to top]

Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th 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, 42, and 70 post injection at week 24

Interventionpercentage of participants (Number)
Cmax ≤1500 ng/dLCmax 1800-2500 ng/dLCmax >2500 ng/dL
C-TU 750 mg92.33.80

[back to top]

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

Interventionpercentage of participants (Number)
C-TU 750 mg62.5

[back to top]

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

Interventionpercentage of participants (Number)
Cmax ≤1500 ng/dLCmax >1500-<1800 ng/dLCmax 1800-2500 ng/dLCmax >2500 ng/dL
C-TU 750 mg92.37.700

[back to top]

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

Interventionpercentage of participants (Number)
Confidence or Self-Esteem ImprovedConfidence or Self-Esteem No ChangeConfidence or Self-Esteem WorsenedSatisfaction with Sexual Performance ImprovedSatisfaction with Sexual Performance No ChangeSatisfaction with Sexual Performance WorsenedGeneral Moods and Behavoir ImprovedGeneral Moods and Behavoir No ChangeGeneral Moods and Behavoir WorsenedOveral Feeling of Well-Being ImprovedOveral Feeling of Well-Being No ChangeOveral Feeling of Well-Being WorsenedSatisfaction with Study Treatment SatisfiedSatisfaction with Study Treatment No OpinionSatisfaction with Study Treatment Not Satisfied
C-TU 750 mg82.617.4080.017.42.680.919.1081.718.3092.27.80

[back to top]

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

,,,
Interventiongm/body weight (kg) (Mean)
protein intake baselineprotein intake 3 monthsprotein intake 6 monthsprotein intake 9 monthsprotein intake 12 months n = 1,1,2,5
Arm 10.970.870.741.151.18
Arm 21.060.941.271.200.74
Arm 30.991.491.051.261.39
Arm 41.001.120.930.821.05

[back to top]

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

,,,
Interventionunits on a scale (Mean)
Benton baselineBenton 3 monthsBenton 6 monthsBenton 9 monthsBenton 12 months
Arm 124.5425.0025.9025.3825.67
Arm 224.3925.4025.1123.8925.5
Arm 325.8825.0726.025.7926.17
Arm 424.6925.6725.0824.9224.08

[back to top]

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

,,,
Interventionunits on a scale (Mean)
Rey baselineRey 3 monthRey 6 monthRey 9 monthRey 12 month
Arm 112.4216.6815.7615.2516.86
Arm 213.5412.8516.1715.1715
Arm 312.8216.2717.3818.0819.27
Arm 412.812.51415.5516.45

[back to top]

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

,,,
Interventionkg (Mean)
leg press baseline Kgleg press 3-months change kgleg press 6-months change kgleg press 9-months change kgleg press 12-months change kg
Arm 1129.19.19210.22714.41614.773
Arm 2109.4-1.34-1.136-5.550
Arm 3137.29.67913.77810.4912.5
Arm 4118.8-2.442.7272.021.515

[back to top]

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

,,,
Interventionpoints (Mean)
Life Satisfaction A baselineLife Satisfaction A 3 monthsLife Satisfaction A 6 monthsLife Satisfaction A 9 monthsLife Satisfaction A 12 months
Arm 113.8312.6713.7014.7515.17
Arm 212.0812.1114.4413.4412.5
Arm 311.3512.2711.2011.5712.17
Arm 412.6914.1313.5413.1713.83

[back to top]

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

,,,
Interventioncc (Mean)
postate volume baseline ccchange prostate volume 6 months ccchange prostate volume 12 months cc
Arm 126.47.62611.42
Arm 229.7-1.984-4.93
Arm 337.1-3.927-1.72
Arm 436.9-1.474-2.891

[back to top]

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

,,,
Interventionsec (Mean)
Trails A baselineTrails A 3 monthsTrails A 6 monthsTrails A 9 monthsTrails A 12 months
Arm 137.5938.532.931.029.17
Arm 246.4242.139.038.5640.0
Arm 336.6533.5331.229.0732.5
Arm 444.044.3336.9243.1743.75

[back to top]

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

,,,
Interventiongm/cc (Mean)
L2-L4 spine BMD baseline gm/ccchange L2-L4 spine BMD 12 month gm/cc
Arm 11.030.049
Arm 21.020.002
Arm 30.990.053
Arm 41.07-0.020

[back to top]

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

,,,
Interventionunits on a scale (Mean)
depression baselinedepression 3 monthsdepression 6 monthsdepression 9 monthsdepression 12 months
Testosterone Finasteride4.933.235.03.693.73
Testosterone Vehicle2.381.801.50.883.33
Vehicle Finasteride3.082.902.221.892.88
Vehicle Placebo2.131.671.622.921.83

[back to top]

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 142.63.64.0444.0715.22
Arm 241.20.6110.5570.63-1.175
Arm 342.04.5934.3313.384.173
Arm 440.3-0.060.514-0.155-0.192

[back to top]

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

,,,
Interventionkg (Mean)
grip strength baseline kgchange grip strength 3 month kgchange grip strength 6 month kgchange grip strength 9 month kgchange grip strength 12 month kg
Testosterone Finasteride18.20.4851.001.3311.174
Testosterone Vehicle17.01.662.021.5581.909
Vehicle Finasteride16.9-0.0450.8121.251.477
Vehicle Placebo17.4720.212-0.0350.1520.72

[back to top]

Prostate-specific Antigen (PSA)

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

Interventionng/mL (Median)
1) Placebo0.8
2) Testosterone Gel0.9
3) T Gel +Dutasteride0.7
4) T Gel+ DMPA0.4

[back to top]

Testosterone Concentration

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo4.0
2) Testosterone Gel4.4
3) T Gel +Dutasteride7.0
4) T Gel+ DMPA1.8

[back to top]

Dihydrotestosterone (DHT) Concentration

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo0.5
2) Testosterone Gel1.8
3) T Gel +Dutasteride0.5
4) T Gel+ DMPA0.6

[back to top]

Dehydroepiandrosterone (DHEA)

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo4.3
2) Testosterone Gel3.5
3) T Gel +Dutasteride3.8
4) T Gel+ DMPA3.2

[back to top]

Androstenedione (AED)

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo0.9
2) Testosterone Gel0.9
3) T Gel +Dutasteride1.8
4) T Gel+ DMPA0.7

[back to top]

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

,
Interventionunits on a scale (Mean)
BaselineMonth 3 (Change from Baseline)Month 6 (Change from Baseline)
Placebo Group4.90.01.5
Treatment Group6.22.30.9

[back to top]

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

,
Interventionunits on a scale (Mean)
BaselineMonth 3 (Change from Baseline)Month 6 (Change from Baseline)
Placebo Group85.6-3.8-5.4
Treatment Group70.715.06.4

[back to top]

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

,
Interventionunits on a scale (Mean)
BaselineMonth 3 (Change from Baseline)Month 6 (Change from Baseline)
Placebo Group4.12.32.7
Treatment Group7.20.7-2.8

[back to top]

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

,
Interventionunits on a scale (Mean)
BaselineMonth 3 (Change from Baseline)Month 6 (Change from Baseline)
Placebo Group55.5-0.1-0.5
Treatment Group57.7-4.51.9

[back to top]

Area Under the Curve-E2

(NCT00663793)
Timeframe: 14 Days

,
Interventionnmol*h/L (Mean)
external matrix 'immediate' releaseexternal matrix 'fast' releaseexternal matrix 'slow' release
Testosterone Only181219611944
Testosterone Plus Finasteride224120023129

[back to top]

Area Under the Curve-Serum T

(NCT00663793)
Timeframe: 14 days

,
Interventionnmol*h/L (Mean)
external matrix 'immediate' releaseexternal matrix 'fast' releaseexternal matrix 'slow' release
Testosterone Only143144162
Testosterone Plus Finasteride198384237

[back to top]

Area Under the Curve-serum DHT

(NCT00663793)
Timeframe: 14-days

,
Interventionnmol*h/L (Mean)
external matrix 'immediate' releaseexternal matrix 'fast' releaseexternal matrix 'slow' release
Testosterone Only364239
Testosterone Plus Finasteride232626

[back to top]

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

,,
Interventionng/dL (Mean)
Cavg (0-24)Cavg (AM dose) with foodCavg (PM dose) with food
Treatment Period 1792765819
Treatment Period 2654657651
Treatment Period 4541533548

[back to top]

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

Interventionng/dL (Mean)
Cavg (AM dose) with foodCavg (AM dose) fasting
Treatment Period 3518241

[back to top]

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 (0-24)AUC (0-12) (AM dose) with foodAUC (12-24) (PM dose) with food
Treatment Period 11900991799830
Treatment Period 21569378817812
Treatment Period 41298066012894

[back to top]

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 foodAUC (0-12) (AM dose) fasting
Treatment Period 362172894

[back to top]

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

,
Interventionunits on a scale (Mean)
SS (BL)SS (W4)SS (W12)
Estring2.53.54.0
Testosterone Cream3.23.74.0

[back to top]

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

Interventionparticipants (Number)
Estring0
Testosterone Cream4

[back to top]

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

,
Interventionunits on a scale (Mean)
RugaePallorPetechiaeMucosal thinningDryness
Estring-1.03-0.88-1.0-0.62-1.03
Testosterone Cream-0.71-0.91-0.74-0.88-0.71

[back to top]

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

,
Interventionpg/ml (Mean)
Baseline E24-week E2
E2 by LC/MS17.77.8
E2 by RIA17.92.9

[back to top]

Serum Estradiol (E2)

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

,
Interventionpg/ml (Mean)
E2 at baselineE2 at 4 weeksE2 at 12 weeks
Estring2759
Testosterone Cream9108

[back to top]

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

,
Interventionunits on a scale (Mean)
SI (BL)SI (W4)SI (W12)SD (BL)SD (W4)SD (W12)
Estring1.21.30.92.92.42.0
Testosterone Cream1.41.21.02.92.11.9

[back to top]

Total Testosterone Levels

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

Interventionng/dl (Mean)
Testosterone at baselineTestosterone at 4 weeksTestosterone at 12 weeks
Testosterone Cream33186171

[back to top]

Luteinizing Hormone Concentration (LH)

(NCT00729859)
Timeframe: Baseline, Day 28

,,
InterventionIU/L (Mean)
BaselineDay 28
Group 1: Acyline + Placebo Gel, Placebo Pill4.30.31
Group 2: Acyline, Testosterone Gel4.70.69
Group 3: Acyline, Testosterone Gel, Anastrozole4.41.55

[back to top]

Fasting Lipid Levels

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

,,
Interventionmmol/L (Mean)
Total cholesterol Day 0Total cholesterol Day 28Total cholesterol Day 56LDL choesterol Day 0LDL cholesterol Day 28LDL cholesterol Day 56HDL cholesterol Day 0HDL cholesterol Day 28HDL cholesterol Day 56Triglycerides Day 0Triglycerides Day 28Triglycerides Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill4.975.444.952.953.292.871.191.371.191.791.731.89
Group 2: Acyline, Testosterone Gel, Placebo Pill4.484.514.142.772.802.491.321.321.320.820.860.80
Group 3: Acyline, Testosterone Gel, Oral Anastrozole4.564.564.272.672.752.511.401.321.301.081.081.02

[back to top]

Fasting Serum Insulin

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

,,
Interventionpicomolar (Mean)
BaselineDay 28Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill546954
Group 2: Acyline, Testosterone Gel, Placebo Pill655964
Group 3: Acyline, Testosterone Gel, Oral Anastrozole504250

[back to top]

Endothelial Progenitor Cells

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

Interventionpercentage of all lymphocytes (Mean)
BaselineDay 28
Group 1: Acyline + Placebo Gel + Placebo Pill0.1010.081

[back to top]

Estradiol Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

,,
Interventionpmol/L (Mean)
BaselineDay 28
Group 1: Acyline + Placebo Gel, Placebo Pill95.431.9
Group 2: Acyline, Testosterone Gel117.8109.0
Group 3: Acyline, Testosterone Gel, Anastrozole Pill96.336.5

[back to top]

Follicle Stimulating Hormone (FSH)

(NCT00729859)
Timeframe: Baseline, 28 days

,,
InterventionIU/L (Mean)
BaselineDay 28
Group 1: Acyline + Placebo Gel, Placebo Pill4.20.42
Group 2: Acyline, Testosterone Gel2.90.39
Group 3: Acyline, Testosterone Gel, Anastrazole Pill2.50.87

[back to top]

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

,,
InterventionHOMA score (Mean)
BaselineDay 28Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill1.82.42.2
Group 2: Acyline, Testosterone Gel, Placebo Pill2.01.91.9
Group 3: Acyline, Testosterone Gel, Oral Anastrozole1.61.41.7

[back to top]

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

,,
InterventionQUICKI index (Mean)
BaselineDay 28Day 56
Group 1: Acyline + Placebo Gel, Placebo Pill0.360.340.35
Group 2: Acyline, Testosterone Gel, Placebo Pill0.350.350.35
Group 3: Acyline, Testosterone Gel, Oral Anastrozole0.360.380.36

[back to top]

Sex Hormone Binding Globulin (SHBG)

(NCT00729859)
Timeframe: Baseline, Day 28

,,
Interventionnmol/L (Mean)
BaselineDay 28
Group 1: Acyline + Placebo Gel, Placebo Pill34.937.5
Group 2: Acyline, Testosterone Gel23.022.1
Group 3: Acyline, Testosterone Gel, Anastrozole Pill27.625.1

[back to top]

Testosterone Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

,,
Interventionnmol/L (Mean)
Baseline testosterone concentrationDay 28 testosterone concentration
Group 1: Acyline + Placebo Gel, Placebo Pill15.40.8
Group 2: Acyline, Testosterone Gel16.317.8
Group 3: Acyline, Testosterone Gel, Anastrozole16.519.0

[back to top]

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

Interventionscore on a scale (Mean)
Testosterone Ophthalmic Solution1.70
Vehicle1.33

[back to top]

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

Interventionunits on a scale (Mean)
Testosterone Ophthalmic Solution0.80
Vehicle0.96

[back to top]

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)

,
InterventionParticipants (Count of Participants)
Month 3Month 6Month 9Month 12
AndroGel® (Testosterone Gel)20242835
Placebo Gel14232220

[back to top]

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)

,
InterventionParticipants (Count of Participants)
Month 3Month 6Month 9Month 12
AndroGel® (Testosterone Gel)77727766
Placebo Gel59736058

[back to top]

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)

,
Interventionunits on the PDQ-Q4 scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)1.40.60.60.50.2
Placebo Gel1.40.1-0.1-0.1-0.1

[back to top]

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)

,
InterventionScore on the IIEF test scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)8.03.43.33.43.1
Placebo Gel7.71.00.50.51.0

[back to top]

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)

,
InterventionScore on the DISF-M-II scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)11.93.53.54.02.6
Placebo Gel11.60.70.80.90.0

[back to top]

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)

,
InterventionScore on the PANAS test scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)15.30.70.90.90.7
Placebo Gel15.40.30.00.40.2

[back to top]

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)

,
InterventionScore on the PANAS test scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)7.5-0.2-0.4-0.2-0.6
Placebo Gel7.40.30.4-0.1-0.1

[back to top]

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)

,
InterventionScore on the FACIT- Fatigue test scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)31.67.87.48.68.0
Placebo Gel31.37.25.97.26.7

[back to top]

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)

,
InterventionParticipants (Count of Participants)
Month 3Month 6Month 9Month 12
AndroGel® (Testosterone Gel)148144148147
Placebo Gel138126127120

[back to top]

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)

,
InterventionScore on the PHQ-9 test scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)6.6-1.3-1.7-1.9-1.8
Placebo Gel6.6-0.8-0.5-1.2-1.1

[back to top]

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)

,
InterventionScore on the SF-36 vitality scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)50.67.47.28.48.2
Placebo Gel49.45.94.55.76.1

[back to top]

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)

,
InterventionScore on the PF-10 test scale (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)65.45.66.55.95.8
Placebo Gel64.84.24.83.32.4

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)1.5
Placebo Gel0.9

[back to top]

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)

Interventionproportion of participants (Mean)
AndroGel® (Testosterone Gel)0.9
Placebo Gel0.2

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)3.3
Placebo Gel2.1

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)1.2
Placebo Gel0.5

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)1.4
Placebo Gel0.4

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)1.5
Placebo Gel0.5

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)2.5
Placebo Gel0.6

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)7.2
Placebo Gel1.5

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)10.8
Placebo Gel2.4

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)9.0
Placebo Gel1.9

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)1.6
Placebo Gel0.7

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)1.6
Placebo Gel0.1

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)1.7
Placebo Gel0.4

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)4.0
Placebo Gel1.1

[back to top]

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)

Interventionmg/cm^3 (Mean)
AndroGel® (Testosterone Gel)7.5
Placebo Gel0.8

[back to top]

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)

Interventionpercentage of change (Mean)
AndroGel® (Testosterone Gel)5.5
Placebo Gel1.2

[back to top]

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)

InterventionAgatston units (Least Squares Mean)
AndroGel® (Testosterone Gel)64
Placebo Gel91

[back to top]

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)

Interventionmm^3 (Mean)
AndroGel® (Testosterone Gel)75
Placebo Gel28

[back to top]

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)

,
InterventionParticipants (Count of Participants)
Month 3Month 6Month 9Month 12
AndroGel® (Testosterone Gel)681513
Placebo Gel4324

[back to top]

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)

,
Interventionpercentage of change in test score (Mean)
Baseline ScoreChange at Month 6Change at Month 12
AndroGel® (Testosterone Gel)14.01.11.3
Placebo Gel14.41.11.4

[back to top]

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)

,
InterventionScore on the Trail Making Test scale (Mean)
Baseline ScoreChange at Month 6Change at Month 12
AndroGel® (Testosterone Gel)86.4-2.1-0.0
Placebo Gel76.71.87.1

[back to top]

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)

,
InterventionScore on the CRT test scale (Mean)
Baseline ScoreChange at Month 6Change at Month 12
AndroGel® (Testosterone Gel)28.70.60.6
Placebo Gel30.00.21.2

[back to top]

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)

,
InterventionScore on the BVRT test scale (Mean)
Baseline ScoreChange at Month 6Change at Month 12
AndroGel® (Testosterone Gel)-8.20.20.3
Placebo Gel-8.20.30.7

[back to top]

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)

,
Interventionmeters (Mean)
Baseline ScoreChange at Month 3Change at Month 6Change at Month 9Change at Month 12
AndroGel® (Testosterone Gel)347.710.28.25.314.3
Placebo Gel344.94.67.83.25.5

[back to top]

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)

Interventionmm^3 (Mean)
AndroGel® (Testosterone Gel)54
Placebo Gel14

[back to top]

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

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

[back to top]

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

Interventionunits on a scale (Number)
Placebo Testim + Viagra1

[back to top]

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

Interventionunits on a scale (Number)
Placebo Testim + Viagra0

[back to top]

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

Interventionnumber of yes answers (Number)
Placebo Testim + Viagra1

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone4.36
Arm II: Standard of Care Therapy + Testosterone28.36

[back to top]

1-year Survival

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

InterventionParticipants (Count of Participants)
Arm I: Standard of Care Therapy + Placebo Testosterone7
Arm II: Standard of Care Therapy + Testosterone6

[back to top]

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

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: 7 weeks

InterventionUnits on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone52.73
Arm II: Standard of Care Therapy + Testosterone46.50

[back to top]

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

Interventionunits on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone47.73
Arm II: Standard of Care Therapy + Testosterone52.22

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone13.35
Arm II: Standard of Care Therapy + Testosterone94.52

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone3.11
Arm II: Standard of Care Therapy + Testosterone1.98

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone12.84
Arm II: Standard of Care Therapy + Testosterone82.46

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone8.89
Arm II: Standard of Care Therapy + Testosterone23.09

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone11.04
Arm II: Standard of Care Therapy + Testosterone43.99

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone9.97
Arm II: Standard of Care Therapy + Testosterone18.16

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone6.57
Arm II: Standard of Care Therapy + Testosterone21.61

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone3.94
Arm II: Standard of Care Therapy + Testosterone44.04

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone11.45
Arm II: Standard of Care Therapy + Testosterone12.34

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone14.57
Arm II: Standard of Care Therapy + Testosterone16.62

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone33.52
Arm II: Standard of Care Therapy + Testosterone12.22

[back to top]

Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks

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: 7 weeks

Interventionkilo-calories per day (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone1338.10
Arm II: Standard of Care Therapy + Testosterone1260.98

[back to top]

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

Interventionkilo-calories per day (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone1329.20
Arm II: Standard of Care Therapy + Testosterone1310.81

[back to top]

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

Interventiongrams (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone17616.58
Arm II: Standard of Care Therapy + Testosterone16776.60

[back to top]

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

Interventiongrams (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone20513.50
Arm II: Standard of Care Therapy + Testosterone18227.33

[back to top]

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

InterventionWatts (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone126.93
Arm II: Standard of Care Therapy + Testosterone157.90

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone11.87
Arm II: Standard of Care Therapy + Testosterone13.88

[back to top]

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

InterventionWatts (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone137.60
Arm II: Standard of Care Therapy + Testosterone169.0

[back to top]

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

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. This outcome was measured after 7 weeks of treatment with study medication. (NCT00878995)
Timeframe: 7 weeks

InterventionNewton-Meters (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone76.75
Arm II: Standard of Care Therapy + Testosterone118.26

[back to top]

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

InterventionNewton-Meters (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone81.77
Arm II: Standard of Care Therapy + Testosterone122.50

[back to top]

Mood as Measured by Profile of Mood States at 7 Weeks

"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: 7 weeks

InterventionUnits on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone28.82
Arm II: Standard of Care Therapy + Testosterone35.78

[back to top]

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

Interventionunits on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone30.73
Arm II: Standard of Care Therapy + Testosterone32.55

[back to top]

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

"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: Baseline

InterventionUnits on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone12.73
Arm II: Standard of Care Therapy + Testosterone21.40

[back to top]

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

InterventionUnits on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone18.73
Arm II: Standard of Care Therapy + Testosterone26.11

[back to top]

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 Testosterone73.55
Arm II: Standard of Care Therapy + Testosterone74.74

[back to top]

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

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: 7 weeks

Interventionscores on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone20.11
Arm II: Standard of Care Therapy + Testosterone24.97

[back to top]

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

Interventionscores on a scale (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone18.83
Arm II: Standard of Care Therapy + Testosterone30.48

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone2.50
Arm II: Standard of Care Therapy + Testosterone20.50

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone3.02
Arm II: Standard of Care Therapy + Testosterone2.39

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone3.62
Arm II: Standard of Care Therapy + Testosterone3.92

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone10.48
Arm II: Standard of Care Therapy + Testosterone2.35

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone4.30
Arm II: Standard of Care Therapy + Testosterone3.13

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone3.82
Arm II: Standard of Care Therapy + Testosterone17.95

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone3.13
Arm II: Standard of Care Therapy + Testosterone12.62

[back to top]

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

InterventionKilograms (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone63.93
Arm II: Standard of Care Therapy + Testosterone62.59

[back to top]

Body Weight as Measured by Scale at Baseline

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

InterventionKilograms (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone65.98
Arm II: Standard of Care Therapy + Testosterone63.11

[back to top]

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

InterventionPercent change (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone-3.31
Arm II: Standard of Care Therapy + Testosterone1.42

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone64.15
Arm II: Standard of Care Therapy + Testosterone191.17

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone67.02
Arm II: Standard of Care Therapy + Testosterone260.69

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone3.02
Arm II: Standard of Care Therapy + Testosterone14.56

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone20.63
Arm II: Standard of Care Therapy + Testosterone11.66

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone21.62
Arm II: Standard of Care Therapy + Testosterone15.71

[back to top]

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

Interventionpicogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone2.13
Arm II: Standard of Care Therapy + Testosterone1.71

[back to top]

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

Interventionng/dL (Least Squares Mean)
Testosterone Undecanoate4.114

[back to top]

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

Interventionng/dL (Least Squares Mean)
Testosterone Undecanoate-4.077

[back to top]

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.

Interventionng/dL (Geometric Mean)
Fasting6.38
Very Low Fat Diet6.73
Low Fat Diet6.88
Normal Diet7.00
High Fat Diet7.18

[back to top]

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

,,
Interventiongrams (Mean)
Lean Body Mass BaselineLean Body Mass Month 1Lean Body Mass Month 2Lean Body Mass Month 3Lean Body Mass Month 4Lean Body Month 5
Continuous Testosterone5774660469.362680.161167.361436.660871.4
Monthly Cycled Testosterone5710159155.456787.85918659838.658846.9
Placebo6234462994.762038.762256.562755.461250.6

[back to top]

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

,,
Interventionpounds (Mean)
Arm Curl BaselineArm Extension BaselineLeg Curl BaselineLeg Extension BaselineArm Curl Month 1Arm Curl Month 2Arm Curl Month 3Arm Curl Month 4Arm Curl Month 5Arm Extension Month 1Arm Extension Month 2Arm Extension Month 3Arm Extension Month 4Arm Extension Month 5Leg Curl Month 1Leg Curl Month 2Leg Curl Month 3Leg Curl Month 4Leg Curl Month 5Leg Extension Month 1Leg Extension Month 2Leg Extension Month 3Leg Extensuion Month 4Leg Extension Month 5
Continuous Testosterone323840663439374138374444444541484850516778768283
Monthly Cycled Testosterone394144734140434345414243444546474350507377807985
Placebo394046703938393840404142424248514848487069747272

[back to top]

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

,,
InterventionnM BCE (Bone Collagen Equivalents) (Mean)
NTX BaselineNTX Five MonthsTRAP5b BaselineTRAP5b Five MonthsOsteocalcin BaselineOsteocalcin Five MonthsBAP BaselineBAP Five MonthsiPTH BaselineiPTH Five MonthsCalcitonin BaselineCalcitonin Five months
Continuous Testosterone151121971715536043
Monthly Cycled Testosterone141122882019372844
Placebo121322882221404533

[back to top]

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

,,
Interventionpg/mL (Mean)
IL-B1 BaselineIL-B1 Five MonthsIL-2 BaselineIL-2 Five MonthsIL-5 BaselineIL-5 Five MonthsIL-6 BaselineIL-6 Five monthsIL-7 BaselineIL-7 Five MonthsIL-8 BaselineIL-8 Five monthsIL-10 BaselineIL-10 Five MonthsIL-12 BaselineIL-12 Five MonthsIL-13 baselineIL-13 Five MonthsIFN gamma BaselineIFN gamma Five MonthsGM-CSF BaselineGM-CSF Five MonthsTNF alpha BaselineTNF alpha Five Months
Continuous Testosterone1.441432.5382.5383.8621.418751.9412510.402513.895.1987516.27638.4562511.8025109.446135.6435.358358.421760.212573.67423.42536.8227.9487514.96513.21515.4138
Monthly Cycled Testosterone0.4753.193.191.453330.790.322864.908576.48711.968823.18886.663754.0628611.25888.341434.2422.6623.3312.724.581.7582.41.31210.08638.1529
Placebo0.140.208331.322.840.60.7055.683755.058.787.684.55754.322522.636325.45257.07510.90237.04543.46510.11536.051.524292.278579.01758.14

[back to top]

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

,,
InterventionPercent per hour (%/hr) (Mean)
BaselineFive Months
Continuous Testosterone0.060.101
Monthly Cycled Testosterone0.060.094
Placebo0.050.066

[back to top]

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

,,
Interventiongm/cm^2 (Mean)
Total BaselineTotal Five MonthsLumbar Spine BaselineLumbar Spine Five MonthsPelvis baselinePelvis Five MonthsForearm BaselineForearm Five Months
Continuous Testosterone1.121.141.161.191.271.280.610.62
Monthly Cycled Testosterone1.071.051.001.001.151.140.590.59
Placebo1.121.081.061.071.461.280.590.61

[back to top]

Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post 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 8

Interventionmg/dL (Mean)
Testosterone Injection104.0
Testosterone Gel94.57
Medrol 6 Day Dose Pack87.5
Testosterone Injection and Medrol 6 Day Dose Pack75.14

[back to top]

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

Interventionng/mL (Mean)
Testosterone Injection1.92
Testosterone Gel2.33
Medrol 6 Day Dose Pack1.85
Testosterone Injection and Medrol 6 Day Dose Pack1.83

[back to top]

Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post 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 8

Interventionng/mL (Mean)
Testosterone Injection1.98
Testosterone Gel2.32
Medrol 6 Day Dose Pack1.78
Testosterone Injection and Medrol 6 Day Dose Pack2.07

[back to top]

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

Interventionpg/mL (Mean)
Testosterone Injection22.86
Testosterone Gel33.69
Medrol 6 Day Dose Pack36.33
Testosterone Injection and Medrol 6 Day Dose Pack34.71

[back to top]

Serum Estradiol Measured on Treatment Day 8 (Post 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 8

Interventionpg/mL (Mean)
Testosterone Injection48.29
Testosterone Gel33.43
Medrol 6 Day Dose Pack30.83
Testosterone Injection and Medrol 6 Day Dose Pack47.14

[back to top]

Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)

"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 1

Interventionng/dL (Mean)
Testosterone Injection307.57
Testosterone Gel363.43
Medrol 6 Day Dose Pack408.17
Testosterone Injection and Medrol 6 Day Dose Pack318.68

[back to top]

Serum Total Testosterone Measured on Treatment Day 2

"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 2

Interventionng/dL (Mean)
Testosterone Injection980.86
Testosterone Gel526.71
Medrol 6 Day Dose Pack191.87
Testosterone Injection and Medrol 6 Day Dose Pack675.86

[back to top]

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

Interventionng/dL (Mean)
Testosterone Injection828.71
Testosterone Gel527.43
Medrol 6 Day Dose Pack206.0
Testosterone Injection and Medrol 6 Day Dose Pack673.29

[back to top]

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

Interventionng/dL (Mean)
Testosterone Injection779.57
Testosterone Gel441.71
Medrol 6 Day Dose Pack271.6
Testosterone Injection and Medrol 6 Day Dose Pack734.57

[back to top]

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

Interventionng/dL (Mean)
Testosterone Injection722.0
Testosterone Gel460.14
Medrol 6 Day Dose Pack246.33
Testosterone Injection and Medrol 6 Day Dose Pack669.71

[back to top]

Serum Total Testosterone Measured on Treatment Day 6

"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 6

Interventionng/dL (Mean)
Testosterone Injection629.0
Testosterone Gel536.43
Medrol 6 Day Dose Pack284.5
Testosterone Injection and Medrol 6 Day Dose Pack645.14

[back to top]

Serum Total Testosterone Measured on Treatment Day 7

"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 7

Interventionng/dL (Mean)
Testosterone Injection578.29
Testosterone Gel485.86
Medrol 6 Day Dose Pack320.0
Testosterone Injection and Medrol 6 Day Dose Pack579.57

[back to top]

Serum Total Testosterone Measured on Treatment Day 8 (Post Study)

"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 8

Interventionng/dL (Mean)
Testosterone Injection454.29
Testosterone Gel435.14
Medrol 6 Day Dose Pack340.17
Testosterone Injection and Medrol 6 Day Dose Pack481.14

[back to top]

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

Interventionnmol/L (Mean)
Testosterone Injection21.78
Testosterone Gel19.86
Medrol 6 Day Dose Pack25.66
Testosterone Injection and Medrol 6 Day Dose Pack24.70

[back to top]

Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post 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 8

Interventionnmol/L (Mean)
Testosterone Injection17.62
Testosterone Gel20.13
Medrol 6 Day Dose Pack19.22
Testosterone Injection and Medrol 6 Day Dose Pack14.57

[back to top]

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

Interventionmg/dL (Mean)
Testosterone Injection171.29
Testosterone Gel165.57
Medrol 6 Day Dose Pack168.00
Testosterone Injection and Medrol 6 Day Dose Pack156.71

[back to top]

Total Cholesterol Measured on Treatment Day 8 (Post 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 8

Interventionmg/dL (Mean)
Testosterone Injection172
Testosterone Gel162.86
Medrol 6 Day Dose Pack166.17
Testosterone Injection and Medrol 6 Day Dose Pack141.86

[back to top]

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

Interventionmg/dL (Mean)
Testosterone Injection140.42
Testosterone Gel164.0
Medrol 6 Day Dose Pack122.5
Testosterone Injection and Medrol 6 Day Dose Pack119.71

[back to top]

Triglycerides Measured on Treatment Day 8 (Post 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 8

Interventionmg/dL (Mean)
Testosterone Injection112.57
Testosterone Gel160.0
Medrol 6 Day Dose Pack155.17
Testosterone Injection and Medrol 6 Day Dose Pack116.28

[back to top]

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

Interventionmg/dL (Mean)
Testosterone Injection28
Testosterone Gel33.14
Medrol 6 Day Dose Pack24.67
Testosterone Injection and Medrol 6 Day Dose Pack23.86

[back to top]

Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post 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 8

Interventionmg/dL (Mean)
Testosterone Injection26.71
Testosterone Gel29.29
Medrol 6 Day Dose Pack31.0
Testosterone Injection and Medrol 6 Day Dose Pack24.71

[back to top]

Cortisol Measured on Treatment Day 8 (Post Study) BEFORE 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 8 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.84
Testosterone Gel5.97
Medrol 6 Day Dose Pack6.28
Testosterone Injection and Medrol 6 Day Dose Pack5.19

[back to top]

C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline 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 1

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.33
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.4

[back to top]

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

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.31
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.3

[back to top]

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

Interventionug/dL (Mean)
Testosterone Injection7.71
Testosterone Gel7.20
Medrol 6 Day Dose Pack4.76
Testosterone Injection and Medrol 6 Day Dose Pack4.15

[back to top]

Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE 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 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.25
Testosterone Gel6.00
Medrol 6 Day Dose Pack6.64
Testosterone Injection and Medrol 6 Day Dose Pack6.28

[back to top]

Cortisol Measured on Treatment Day 8 (Post 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 8 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.05
Testosterone Gel6.28
Medrol 6 Day Dose Pack4.40
Testosterone Injection and Medrol 6 Day Dose Pack5.78

[back to top]

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

Interventionug/dL (Mean)
Testosterone Injection46.34
Testosterone Gel34.16
Medrol 6 Day Dose Pack62.55
Testosterone Injection and Medrol 6 Day Dose Pack46.07

[back to top]

Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post 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 8

Interventionug/dL (Mean)
Testosterone Injection37.96
Testosterone Gel35.54
Medrol 6 Day Dose Pack34.74
Testosterone Injection and Medrol 6 Day Dose Pack36.07

[back to top]

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)

Interventionunits on a scale (Mean)
Testosterone Injection1.84
Testosterone Gel1.79
Medrol 6 Day Dose Pack2.19
Testosterone Injection and Medrol 6 Day Dose Pack1.57

[back to top]

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

Interventionpercent (Mean)
Testosterone Injection39.17
Testosterone Gel38.4
Medrol 6 Day Dose Pack40.45
Testosterone Injection and Medrol 6 Day Dose Pack39.86

[back to top]

Hematocrit Measured on Treatment Day 8 (Post 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 8

Interventionpercent (Mean)
Testosterone Injection38.74
Testosterone Gel37.23
Medrol 6 Day Dose Pack40.53
Testosterone Injection and Medrol 6 Day Dose Pack39.24

[back to top]

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

Interventionmg/dL (Mean)
Testosterone Injection40.29
Testosterone Gel38.86
Medrol 6 Day Dose Pack46.50
Testosterone Injection and Medrol 6 Day Dose Pack42.14

[back to top]

High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post 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 8

Interventionmg/dL (Mean)
Testosterone Injection41.29
Testosterone Gel36.71
Medrol 6 Day Dose Pack47.67
Testosterone Injection and Medrol 6 Day Dose Pack43.43

[back to top]

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)

Interventionunits on a scale (Mean)
Testosterone Injection2.25
Testosterone Gel1.47
Medrol 6 Day Dose Pack2.26
Testosterone Injection and Medrol 6 Day Dose Pack1.86

[back to top]

Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline 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 1

Interventionng/mL (Mean)
Testosterone Injection71.77
Testosterone Gel69.2
Medrol 6 Day Dose Pack61.42
Testosterone Injection and Medrol 6 Day Dose Pack90.74

[back to top]

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

Interventionng/mL (Mean)
Testosterone Injection80.16
Testosterone Gel72.11
Medrol 6 Day Dose Pack69.17
Testosterone Injection and Medrol 6 Day Dose Pack54.86

[back to top]

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

InterventionuIu/mL (Mean)
Testosterone Injection8.53
Testosterone Gel10.28
Medrol 6 Day Dose Pack4.09
Testosterone Injection and Medrol 6 Day Dose Pack9.89

[back to top]

Insulin Measured on Treatment Day 8 (Post 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 8

InterventionuIu/mL (Mean)
Testosterone Injection7.47
Testosterone Gel10.58
Medrol 6 Day Dose Pack3.92
Testosterone Injection and Medrol 6 Day Dose Pack3.89

[back to top]

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

Interventionmg/dL (Mean)
Testosterone Injection103.0
Testosterone Gel93.57
Medrol 6 Day Dose Pack96.83
Testosterone Injection and Medrol 6 Day Dose Pack90.71

[back to top]

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)

,
Interventionunits on a scale (Mean)
FACIT-F Total Score (29 days-baseline)FACIT-F Fatigue Subscale (29 days-baseline)
Placebo1314
Testosterone1212

[back to top]

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)

,
Interventionunits on a scale (Mean)
Anxiety, ESASDepression, HADSWell being, ESASSleep, ESASAppetite, ESASDyspnea, ESASDrowsiness, ESASNausea, ESASFatigue, ESASPain, ESAS
Placebo5634434263
Testosterone7755525263

[back to top]

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

Interventionparticipants (Number)
Treatment Group7

[back to top]

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

Interventiondays (Median)
Treatment Group221

[back to top]

Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.

(NCT01084759)
Timeframe: 3 months

InterventionPercentage of Participants (Number)
Treatment Group42.9

[back to top]

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

InterventionPercent Change (Mean)
AndroGel (Testosterone Gel) 1%-2.38

[back to top]

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

InterventionPercent Change (Mean)
AndroGel (Testosterone Gel) 1%-29.0

[back to top]

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

InterventionPercent Change (Mean)
AndroGel (Testosterone Gel) 1%-21.5

[back to top]

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

InterventionPercent Change (Mean)
AndroGel (Testosterone Gel) 1%115.7

[back to top]

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

Interventionunits on a scale (Mean)
Testosterone0.106

[back to top]

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

Interventionpercentage of Arterial stiffness (Mean)
Testosterone1.067

[back to top]

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

Interventionunits on a scale (Mean)
Testosterone0.06

[back to top]

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

Interventionunits on a scale (Mean)
Testosterone5.05

[back to top]

AUC0-t of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Interventionng.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

[back to top]

Cmax of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Interventionng/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

[back to top]

Cavg of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Interventionng/dL (Mean)
10.0 mg of TBS-1, 4.0% T.I.D.413
13.5 mg of TBS-1, 4.5% B.I.D408
11.25 mg of TBS-1, 4.5% T.I.D396

[back to top]

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

Interventionmeters per second (Mean)
Placebo/Low Protein0.15
Placebo/High Protein0.11
Testosterone/Low Protein0.06
Testosterone/High Protein0.08

[back to top]

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

Interventionunits on a scale (Mean)
Placebo/Low Protein-0.56
Placebo/High Protein1.17
Testosterone/Low Protein0.32
Testosterone/High Protein2.68

[back to top]

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

,,,
Interventionnewton (Mean)
Maximal voluntary strength in leg pressMaximal voluntary strength in chest press
Placebo/High Protein156.016.6
Placebo/Low Protein134.641.5
Testosterone/High Protein191.459.3
Testosterone/Low Protein201.864.5

[back to top]

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

Interventionunits on a scale (Mean)
Placebo/Low Protein-1.4
Placebo/High Protein-5.5
Testosterone/Low Protein2.1
Testosterone/High Protein-2.9

[back to top]

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

,,,
Interventionunits on a scale (Mean)
Affects Expressiveness Index (AEI)Positive Total score (PTOT)Negative Total score (NTOT)
Placebo/High Protein1.452.10-0.65
Placebo/Low Protein0.651.38-1.50
Testosterone/High Protein-3.171.89-5.53
Testosterone/Low Protein-0.500.69-0.88

[back to top]

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

,,,
Interventionwatts (Mean)
UnloadedLoaded
Placebo/High Protein55.483.7
Placebo/Low Protein50.856.8
Testosterone/High Protein4.226.9
Testosterone/Low Protein53.256.6

[back to top]

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

Interventionkg (Mean)
Placebo/Low Protein0.14
Placebo/High Protein0.74
Testosterone/Low Protein4.43
Testosterone/High Protein4.13

[back to top]

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

Interventionmeters (Mean)
Placebo/Low Protein44.2
Placebo/High Protein49.9
Testosterone/Low Protein38.2
Testosterone/High Protein25.5

[back to top]

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

Interventionunits on a scale (Mean)
Placebo/Low Protein0.14
Placebo/High Protein-0.14
Testosterone/Low Protein-0.53
Testosterone/High Protein1.05

[back to top]

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

Interventionwatts (Mean)
Placebo/Low Protein26.9
Placebo/High Protein96.9
Testosterone/Low Protein61.5
Testosterone/High Protein81.7

[back to top]

DHEA

(NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 129.3
Arm 226.2
Arm 322.1
Arm 426.8
Arm 524.4
Arm 618.6

[back to top]

Androstenedione

(NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 10.16
Arm 20.11
Arm 30.12
Arm 40.13
Arm 50.18
Arm 60.14

[back to top]

Prostate Tissue DHT Concentrations After Treatment

To measure intraprostatic dihydrotestosterone [DHT] levels (NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel4.05
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g4.26
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.52.99
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g3.88
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g4.12
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g5.11

[back to top]

Prostate Tissue Testosterone Concentrations After Treatment

To measure intraprostatic testosterone levels (NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel0.3
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g0.13
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.50.125
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g0.18
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g0.195
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g0.3

[back to top]

Prostate Volume

(NCT01327495)
Timeframe: 12 weeks

Interventioncm^3 (Median)
Arm 119
Arm 218
Arm 319
Arm 415
Arm 516
Arm 620

[back to top]

Serum Testosterone

(NCT01327495)
Timeframe: 12 weeks

Interventionng/mL (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel4.6
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g1.9
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.53.4
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g3.5
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g6.1
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g7.7

[back to top]

Progesterone

(NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 10.09
Arm 20.08
Arm 30.06
Arm 40.08
Arm 50.09
Arm 60.07

[back to top]

Pregnenolone

(NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 128.7
Arm 229.5
Arm 332.7
Arm 432.4
Arm 527.9
Arm 623.9

[back to top]

International Prostate Symptom Score (IPSS)

IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic (NCT01327495)
Timeframe: 12 weeks

Interventionunits on a scale (Median)
Arm 11
Arm 22
Arm 32.5
Arm 40
Arm 52.5
Arm 64

[back to top]

Dihydrotestosterone (DHT)

(NCT01327495)
Timeframe: 12 weeks

Interventionng/mL (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel0.3
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g0.6
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.50.9
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g1.0
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g1.5
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g1.8

[back to top]

Androsterone

(NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 10.17
Arm 20.15
Arm 30.12
Arm 40.17
Arm 50.17
Arm 60.21

[back to top]

17-OHPreg

(NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 11.19
Arm 21.25
Arm 31.23
Arm 41.05
Arm 51.02
Arm 61.36

[back to top]

17-OHP

(NCT01327495)
Timeframe: 12 weeks

Interventionng/g (Median)
Arm 10.05
Arm 20.05
Arm 30.05
Arm 40.05
Arm 50.05
Arm 60.05

[back to top]

Prostate Specific Antigen

(NCT01327495)
Timeframe: 12 weeks

Interventionng/dL (Median)
Arm 10.82
Arm 20.48
Arm 30.61
Arm 40.58
Arm 50.52
Arm 60.76

[back to top]

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

Interventionng/dL (Mean)
Medium Dose TBS-2 - Multiple Dose0.944

[back to top]

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

Interventionng*h/dL (Geometric Mean)
Low Dose TBS-2 Single Dose223.981
Medium Dose TBS-2 Single Dose328.002
High Dose TBS-2 Single Dose834.391
Medium Dose TBS-2 Multiple-Dose553.325

[back to top]

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

Interventionpg*h/mL (Geometric Mean)
Low Dose TBS-2 - Single Dose105.763
Medium Dose TBS-2 - Single Dose75.97
High Dose TBS-2 - Single Dose43.97
Medium Dose TBS-2 - Multiple Dose400.264

[back to top]

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

Interventionng/dL (Geometric Mean)
Low Dose TBS-2 - Single Dose34.058
Medium Dose TBS-2 - Single Dose62.880
High Dose TBS-2 - Single Dose113.912
Medium Dose TBS-2 - Multiple Dose137.555

[back to top]

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

Interventionng*h/dL (Geometric Mean)
Low Dose TBS-2 - Single Dose23.515
Medium Dose TBS-2 - Single Dose38.457
High Dose TBS-2 - Single Dose85.180
Medium Dose TBS-2 - Multiple Dose122.194

[back to top]

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

,,
InterventionPercent change (Mean)
lumbar spineTotal hipfemoral neck
BMI Group 13.000.140.71
BMI Group 24.901.74-0.33
BMI Group 33.90-0.270.16

[back to top]

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

,,
InterventionPercent change (Mean)
C-telopeptideOsteocalcin
GC Genotype for the rs1062033 Polymorphism of the5.89-20.59
GG Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene-14.49-26.96
GG Genotype for the rs1062033 Polymorphism of the CYP19A1 Gene48.9633.59

[back to top]

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

Interventionpercent change (Mean)
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene11.56
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene9.67
CC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene9.46

[back to top]

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

Interventionpercent change (Mean)
GG Genotype for the rs700518 Polymorphism in the cYP19A1 Gene25.0
GA Genoypr for the rs700518 Polymorphism of the CYP19A1 Gene65.25
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene113.33

[back to top]

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

InterventionPercent change (Mean)
GG Genotype for the rs700518 Polymorphism of the CYP19A1 Gene11.32
GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene9.71
AA Genotype for the rs700518 Polymorphism of the9.41

[back to top]

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

Interventionprecent change (Mean)
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene85.15
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene62.86
CC Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene52.93

[back to top]

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

Interventionpercent change (Mean)
GG Genotype for the rs700518 Polymor[Hism of the CYP19A1 Gene105.78
GA Genotype of the rs700518 Polymorphism in CYP19A1 Gen58.52
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene44.44

[back to top]

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

,,
Interventionpercent change (Mean)
Lumbar spineTotal hipFemoral neck
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene3.820.08-1.25
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene4.130.931.51
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene3.690.38-1.09

[back to top]

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

,
InterventionPercent change (Mean)
LUMBAR SPINETOTAL HIPFEMORAL NECK
Subjects With Diabetes Mellitus4.051.811.63
Subjects Without Diabetes Mellitus3.280.53-0.55

[back to top]

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

,,
Interventionperecent change (Mean)
C-teloepetideOsteocalcin
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene-9.75-7.27
GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene3.35-31.22
GG Genotype for RS 700518 of the CYP19A1 Gene41.4712.40

[back to top]

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

,
InterventionPercentage Changes (Mean)
C-telopeptideOsteocalcin
Subjects With Diabetes Mellitus73.5520.54
Subjects Without Diabetes Mellitus2.05-6.62

[back to top]

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

,,
InterventionPERCENT CHANGE (Mean)
LUMBAR SPINEFEMORAL NECKTOTAL HIP
CC Genotype for the rs10620333.740.220.64
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene2.850.640.70
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene4.72-1.040.33

[back to top]

Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.

The Cmax for plasma concentration. (NCT01386606)
Timeframe: Week 6

Interventionng/mL (Mean)
Androxal 6.25 mg1.8154
Androxal 12.5 mg3.3899
Androxal 25 mg16.2993

[back to top]

Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.

The Tmax for plasma concentration. (NCT01386606)
Timeframe: Week 6

Interventionh (Mean)
Androxal 6.25 mg2.33
Androxal 12.5 mg2.42
Androxal 25 mg2.41

[back to top]

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

InterventionNumber of Subjects (Number)
Androxal Pooled Dose Levels35

[back to top]

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

,,,
Interventionng/dL (Mean)
TTavg at BaselineTTavg at Week 6TTmax at BaselineTTmax at Week 6
AndroGel322.4543.9562.3930.1
Androxal 12.5 mg373.6460.8513.7607.5
Androxal 25 mg298.3586.7425.9764.3
Androxal 6.25 mg262.3392.4358.5524.5

[back to top]

Change in Follicle Stimulating Hormone (FSH)

Changes in morning FSH after continuous dosing (NCT01386606)
Timeframe: Baseline, Week 2, Week 4, Week 6

,,,
InterventionmIU/mL (Mean)
Morning FSH at BaselineMorning FSH at Week 2Morning FSH Change from Baseline at Week 2Morning FSH at Week 4Morning FSH Change from Baseline at Week 4Morning FSH at Week 6Morning FSH Change from Baseline at Week 6
AndroGel6.383.80-2.583.72-2.663.35-3.03
Androxal 12.5 mg5.637.772.147.121.488.192.56
Androxal 25 mg6.3111.415.0912.346.0313.457.14
Androxal 6.25 mg4.616.181.606.451.665.691.42

[back to top]

Change in Leuteinizing Hormone (LH)

Changes in morning LH after continuous dosing (NCT01386606)
Timeframe: Baseline, Week 2, Week 4, Week 6

,,,
InterventionmIU/mL (Mean)
Morning LH at BaselineMorning LH at Week 2Morning LH Change from Baseline at Week 2Morning LH at Week 4Morning LH Change from Baseline at Week 4Morning LH at Week 6Morning LH Change from Baseline at Week 6
AndroGel3.572.00-1.571.88-1.692.2-1.41
Androxal 12.5 mg4.828.603.787.202.388.23.39
Androxal 25 mg4.989.644.6611.786.7914.59.51
Androxal 6.25 mg3.635.491.996.923.436.12.60

[back to top]

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

Interventionng*h/mL (Mean)
Androxal 6.25 mg21.200
Androxal 12.5 mg34.012
Androxal 25 mg150.51

[back to top]

% 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

InterventionParticipants (Count of Participants)
Oral Testosterone Undecanoate (TU)61

[back to top]

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

Interventionpercentage of partipants (Geometric Mean)
Oral Testosterone Undecanoate (TU)83.6
Topical Testosterone Gel79.2

[back to top]

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

,,
InterventionParticipants (Count of Participants)
Cmax <=1500 ng/dL1800 ng/dL <= Cmax <=2500 ng/dLCmax >2500 ng/dL
TBS-1 - b.i.d.10761
TBS-1 - b.i.d./t.i.d.7720
TBS-1 - t.i.d.5810

[back to top]

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

InterventionParticipants (Count of Participants)
TBS-1 - b.i.d.76
TBS-1 - b.i.d./t.i.d.43
TBS-1 - t.i.d.61

[back to top]

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

Interventionpercent change of bone mineral density (Mean)
Testosterone and Placebo Alendronate2.52
Alendronate and Placebo Testosterone0.61
Testosterone and Alendronate3.16

[back to top]

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

,
Interventionscore on a scale (Mean)
6 weeks post op12 weeks post op24 weeks post op
Placebo65.573.286.6
Testosterone63.276.784

[back to top]

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

,
InterventionNm (Mean)
6 weeks post op12 weeks post op24 weeks post op
Placebo-33.4-6.619.0
Testosterone-53.5-18.319.2

[back to top]

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

,
Interventionkg (Mean)
6 weeks post op12 weeks post op24 weeks post op
Placebo-0.10.011.05
Testosterone2.82.162.13

[back to top]

Metabolic Profile

Basal Metabolic Rate (NCT01652040)
Timeframe: 16 weeks

,
Interventionkcal/day (Mean)
BaselinePost-Intervention (After 16 weeks)
RT+Tp15251665
Testosterone Replacement Patches (Tp)14911502

[back to top]

Body Composition

Changes in body composition fat mass (NCT01652040)
Timeframe: 16 weeks

,
Interventionpercentage of fat mass (Mean)
BaselinePost-Intervention (After 16 weeks)
RT+Tp31.8430.75
Testosteroe Replacement Patches (Tp)33.432.12

[back to top]

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

,,,
Interventionkg (Mean)
Change in fat massChange in lean mass
Acyline & Placebo Gel & Placebo Pill1.1-1.2
Acyline & Testosterone Gel & Letrozole0.5-0.3
Acyline & Testosterone Gel 1.25g/d & Placebo Pill0.7-1.4
Acyline & Testosterone Gel 5g/d & Placebo Pill-0.40.0

[back to top]

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

Interventionunits on a scale (Median)
Acyline & Placebo Gel & Placebo Pill5.0
Acyline & Testosterone Gel 1.25g/d & Placebo Pill9.4
Acyline & Testosterone Gel 5g/d & Placebo Pill7.2
Acyline & Testosterone Gel & Letrozole7.3

[back to top]

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

Interventiongene copy number per ng RNA (Mean)
Acyline + Placebo Gel + Placebo Pills7493
Acyline + Testosterone Gel (1.25g/d) + Placebo Pills8224
Acyline + Testosterone Gel (5g/d) + Placebo Pills7885
Acyline + Testosterone Gel (5g/d) + Letrozole8320

[back to top]

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

Interventionpercent (Mean)
Oral TU0.38
Transdermal T-gel0.37

[back to top]

Absolute Change From Baseline in HDL

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

Interventionmg/dL (Mean)
Oral TU2.4
Transdermal T-gel4.0

[back to top]

Absolute Change From Baseline in Hgb

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

Interventiong/dL (Mean)
Oral TU0.36
Transdermal T-gel0.36

[back to top]

Absolute Change From Baseline in LDL

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

Interventionmg/dL (Mean)
Oral TU-1.5
Transdermal T-gel6.0

[back to top]

Absolute Change From Baseline in Prostate Volume

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

Interventioncc (Mean)
Oral TU1.09
Transdermal T-gel0.40

[back to top]

Absolute Change From Baseline in T Cholesterol

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

Interventionmg/dL (Mean)
Oral TU0.2
Transdermal T-gel8.2

[back to top]

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

Interventionunits on a scale (Median)
Change in SF-36 after round 1 of BATChange in FACT-P after round 1 of BATChange in IIEF after round 1 of BATChange in IPSS after round 1 of BAT
ADT Plus IM Testosterone3.23.5100

[back to top]

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

Interventionparticipants (Number)
Patients with radiographic/clinical progressionPatients without radiographic/clinical progression
ADT Plus IM Testosterone623

[back to top]

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

Interventionparticipants (Number)
Patients with PSA <0.2 ng/mlPatients with PSA ≥0.2 ng/ml
ADT Plus IM Testosterone326

[back to top]

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

Interventionpg/ml (Mean)
ADT Plus IM Testosterone-159.77

[back to top]

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

Interventionparticipants (Number)
ADT Plus IM Testosterone17

[back to top]

Change in Waist Circumference

(NCT01750398)
Timeframe: Bseline, 6 months and 9 months.

Interventioncm (Mean)
Following ADT lead inFollowing round 1 of BAT
ADT Plus IM Testosterone3.9-1.09

[back to top]

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.

Interventionkg (Mean)
Following ADT lead inFollowing round 1 of BAT
ADT Plus IM Testosterone2.081.21

[back to top]

Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL

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

InterventionParticipants (Count of Participants)
Oral Testosterone Undecanoate87

[back to top]

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

InterventionParticipants (Count of Participants)
Cmax less that 1500 ng/dLCmax between 1500 and 1800 ng/dLCmax >1800 to 2500 ng/dLCmax >2500 ng/dL
Oral Testosterone Undecanoate951074

[back to top]

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

Interventionunits on a scale (Mean)
Testosterone15.3
Placebo14.1

[back to top]

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

Interventionunits on a scale (Mean)
Testosterone4.0
Placebo3.7

[back to top]

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

Interventionunits on a scale (Mean)
Testosterone45.1
Placebo47.5

[back to top]

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

Interventionunits on a scale (Least Squares Mean)
Placebo Solution7.5
Testosterone Solution10.5

[back to top]

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

Interventionunits on a scale (Least Squares Mean)
Placebo Solution6.3
Testosterone Solution11.4

[back to top]

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

Interventionparticipants (Number)
Placebo Solution43
Testosterone Solution217

[back to top]

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

,
Interventionunits on a scale (Least Squares Mean)
Change from Baseline to Week 12Change from Baseline to Week 36 (n=247, 255)
Placebo Solution-0.7-0.7
Testosterone Solution-0.9-0.7

[back to top]

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

,
Interventionparticipants (Number)
Double-Blind Baseline (n=350, 347)Week 12 (n=289, 299)Open Label Baseline (n=269, 278)Week 36 (n=219, 223)
Placebo Solution1304
Testosterone Solution0404

[back to top]

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

Interventionparticipants (Number)
QuickShot™ - 100 mg Treatment A10
QuickShot™ - 50 mg Treatment B12
Delatestryl 200 mg IM Treatment C3

[back to top]

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

Interventionng*hr/dL (Mean)
QuickShot™ - 100 mg Treatment A150445.2
QuickShot™ - 50 mg Treatment B70955.7
Delatestryl 200 mg IM Treatment C278657.9

[back to top]

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

Interventionng/dL (Mean)
QuickShot™ - 100 mg Treatment A895.5
QuickShot™ - 50 mg Treatment B422.4
Delatestryl 200 mg IM Treatment C1658.7

[back to top]

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

Interventionng/dL (Mean)
QuickShot™ - 100 mg Treatment A1345.6
QuickShot™ - 50 mg Treatment B622.4
Delatestryl 200 mg IM Treatment C261.9

[back to top]

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

Interventionpercentage 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 Solution3.9511.8444.7438.161.320.000.005.2625.0039.4730.260.000.000.000.0022.7345.4531.820.000.000.004.5522.7336.3631.824.550.000.000.0050.000.0050.000.000.000.0016.6733.330.0050.000.000.000.007.7927.2735.0628.571.300.000.00

[back to top]

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)

Interventionng/dL (Mean)
Topical Testosterone Solution354.8

[back to top]

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)

Interventionpercentage of participants (Number)
Topical Testosterone Solution94.7

[back to top]

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

Interventionpercentage 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 Solution4.0016.0044.0036.000.000.000.007.8927.6340.7922.371.320.000.004.5518.1850.0022.734.550.000.004.5527.2740.9122.734.550.000.000.0033.3350.0016.670.000.000.0016.6716.6733.3333.330.000.000.0010.3929.8735.0622.082.600.000.00

[back to top]

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

InterventionParticipants (Count of Participants)
Cohort A:Post-enzalutamide6
Cohort B: Post-abiraterone2
Cohort C: Castration Only4
Cohort D: Mutation0

[back to top]

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

InterventionParticipants (Count of Participants)
Cohort A:Post-enzalutamide9
Cohort B: Post-abiraterone5
Cohort C: Castration Only4
Cohort D: Mutation2

[back to top]

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

Interventionmonths (Median)
Cohort A:Post-enzalutamide3.3
Cohort B: Post-abiraterone3.2
Cohort C: Castration Only0.93
Cohort D: Mutation3

[back to top]

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

Interventionmonths (Median)
Cohort A:Post-enzalutamide5.5
Cohort B: Post-abiraterone3.7
Cohort C: Castration OnlyNA

[back to top]

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

InterventionParticipants (Count of Participants)
Cohort A:Post-enzalutamide15
Cohort B: Post-abiraterone3
Cohort D: Mutation2

[back to top]

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

InterventionParticipants (Count of Participants)
Cohort A:Post-enzalutamide30
Cohort B: Post-abiraterone29
Cohort C: Castration Only29
Cohort D: Mutation7

[back to top]

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

,,
Interventionscore on a scale (Mean)
BaselineCycle 1 Day 85
Cohort A:Post-enzalutamide13.2810.64
Cohort B: Post-abiraterone16.8613.85
Cohort C: Castration Only1311.55

[back to top]

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

,,
Interventionscore on a scale (Mean)
BaselineBAT C1D85
Cohort A:Post-enzalutamide824.13
Cohort B: Post-abiraterone7.3324.94
Cohort C: Castration Only12.5622.44

[back to top]

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

,,
Interventionscore on a scale (Mean)
BaselineBAT C1D85
Cohort A:Post-enzalutamide46.1545.1
Cohort B: Post-abiraterone4845.22
Cohort C: Castration Only41.2444.48

[back to top]

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

,,
Interventionscore on a scale (Mean)
BaselineCycle 1 Day 85
Cohort A:Post-enzalutamide72.2371.76
Cohort B: Post-abiraterone64.3673.97
Cohort C: Castration Only69.7273.40

[back to top]

Safety and Tolerability

"Incidence of adverse events throughout the study~Incidence and severity of injection site reactions throughout the study" (NCT02159469)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Patients with any TEAEPatients with any TEAE related to IPPatients with any SAEPatients with TEAE leading to discontinuationPatients discontinued due to IP related TEAEPatients with any adverse event leading to death
Testosterone Enanthate Auto-injector1256633011

[back to top]

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

InterventionParticipants (Count of Participants)
Testosterone Enanthate Auto-injector139

[back to top]

Vd/F (L)

Vd/F (L) = Apparent volume of distribution (NCT02233751)
Timeframe: 168 hours

,
InterventionLiters (Mean)
TTTE
Testosterone Enanthate 200 mg10959.562366.4
Testosterone Enanthate 50 mg6655.8NA

[back to top]

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)
TTTE
Testosterone Enanthate 200 mg362627.462497.5
Testosterone Enanthate 50 mg279062.2NA

[back to top]

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)
TTTE
Testosterone Enanthate 200 mg176112.833535.5
Testosterone Enanthate 50 mg103731.56122.2

[back to top]

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

,
Interventionhours (Mean)
TTTE
Testosterone Enanthate 200 mg19.0074.00
Testosterone Enanthate 50 mg40.5182.01

[back to top]

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

,
Interventionng/dL (Mean)
Serum testosteroneSerum testosterone enanthate
Testosterone Enanthate 200 mg1487.0267.33
Testosterone Enanthate 50 mg773.749.25

[back to top]

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

,
Interventionhours (Mean)
TTTE
Testosterone Enanthate 200 mg131.75133.00
Testosterone Enanthate 50 mg261.73NA

[back to top]

Clearance CL/F (L/hr)

Clearance - volume of plasma from which TT/TE is completely removed per unit time (NCT02233751)
Timeframe: 168 hours

,
InterventionL/hr (Mean)
TTTE
Testosterone Enanthate 200 mg60.46352.84
Testosterone Enanthate 50 mg18.07NA

[back to top]

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

,
Interventionpercent change (Mean)
6 months12 months
Placebo Treatment-0.9-1.9
Testosterone Enanthate, Finasteride7.911.4

[back to top]

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

,
Interventionpercent change (Mean)
6 months12 months
Placebo Treatment-3.20.2
Testosterone Enanthate, Finasteride-8.2-13.6

[back to top]

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

,
Interventionpercent change (Mean)
6 months12 months
Placebo Treatment-4.7-1.9
Testosterone Enanthate, Finasteride-6.8-8.7

[back to top]

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

,
Interventionpercent change (Mean)
6 months12 months
Placebo Treatment-8.60.5
Testosterone Enanthate, Finasteride19.915.5

[back to top]

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

,
Interventionpercent change (Mean)
Change at 6 monthsChange at 12 months
Placebo Treatment-0.51.1
Testosterone Enanthate, Finasteride1.71.2

[back to top]

Absolute Change in Walking Speed

Absolute change in 10 m walking speed (NCT02248701)
Timeframe: Baseline, 6 months, 12 months

,
Interventionmeters/second (m/s) change (Mean)
6 months12 months
Placebo Treatment0.050.01
Testosterone Enanthate, Finasteride00.10

[back to top]

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

,
Interventionscore on a scale (Mean)
Month 1Month 3Month 6Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate38.1338.3939.2341.67
Arm B: Enzalutamide32.6033.5134.5134.58

[back to top]

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

,
Interventionscore on a scale (Mean)
EF - baseline to month 1EF - baseline to month 3EF - baseline to month 6EF - baseline to month 12OF - baseline to month 1OF - baseline to month 3OF - baseline to month 6OF - baseline to month 12SD - baseline to month 1SD - baseline to month 3SD - baseline to month 6SD - baseline to month 12IS - baseline to month 1IS - baseline to month 3IS - baseline to month 6IS - baseline to month 12OS - baseline to month 1OS - baseline to month 3OS - baseline to month 6OS - baseline to month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate1.172.652.362.50.911.932.192.930.971.852.522.380.361.550.742.400.651.130.602.00
Arm B: Enzalutamide0.090.050.650.050.25-0.020.040.17-0.270.100.180.30-0.010.050.080.000.170.25-0.090.20

[back to top]

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

,
Interventionscore on a scale (Mean)
BaselineMonth 1Month 3Month 6Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate63.1661.6862.3463.4967.35
Arm B: Enzalutamide61.8956.9455.3458.6759.65

[back to top]

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

,
Interventionscore on a scale (Mean)
BaselineMonth 1Month 3Month 6Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate13.8914.2814.4414.2614.24
Arm B: Enzalutamide13.9614.9015.4314.8013.48

[back to top]

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

,
Interventionscore on a scale (Mean)
BaselineMonth 1Month 3Month 6Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate1.221.552.001.961.04
Arm B: Enzalutamide1.272.261.941.841.70

[back to top]

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

,
Interventionscore on a scale (Mean)
BaselineMonth 1Month 3Month 6Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate33.9933.7233.2333.9636.24
Arm B: Enzalutamide32.3532.3331.4831.8429.88

[back to top]

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

,
Interventionscore on a scale (Mean)
BaselineMonth 1Month 3Month 6Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate1.291.191.671.570.76
Arm B: Enzalutamide1.201.941.621.811.13

[back to top]

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

Interventionmonth (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate2.79
Arm B: Enzalutamide3.81

[back to top]

Radiographic Progression

Number of months until 20% increase in the sum of target lesions on CT scans. (NCT02286921)
Timeframe: up to 2 years

Interventionmonths (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate5.75
Arm B: Enzalutamide8.28

[back to top]

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

InterventionParticipants (Count of Participants)
Arm A: Testosterone Cypionate or Testosterone Enanthate14
Arm B: Enzalutamide18

[back to top]

Progression Free Survival on Crossover Treatment

Time from initiation of therapy to progression on crossover treatment (NCT02286921)
Timeframe: up to 2 years

Interventionmonths (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate28.2
Arm B: Enzalutamide19.6

[back to top]

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

Interventionmonths (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate5.62
Arm B: Enzalutamide5.72

[back to top]

Overall Survival

Time until death for any reasons (NCT02286921)
Timeframe: up to 3 years

Interventionmonths (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate32.9
Arm B: Enzalutamide29

[back to top]

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

InterventionParticipants (Count of Participants)
Arm A: Testosterone Cypionate or Testosterone Enanthate8
Arm B: Enzalutamide1

[back to top]

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

Interventioncm (Mean)
Testosterone Treatment0.9
No Treatment-0.3

[back to top]

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

Interventionkg (Mean)
Testosterone Treatment1.4
No Treatment0.6

[back to top]

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

Interventionscore on a scale (Mean)
Testosterone Treatment-0.12
No Treatment0.92

[back to top]

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

Interventionpmol/l (Mean)
Testosterone Treatment1377
No Treatment2208

[back to top]

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

InterventionmIU/mL (Mean)
Testosterone Treatment1.8
No Treatment1.7

[back to top]

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

Interventionpg/ml (Mean)
Testosterone Treatment244
No Treatment355

[back to top]

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

InterventionmIU/mL (Mean)
Testosterone Treatment2.5
No Treatment2.5

[back to top]

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

Interventionng/dl (Mean)
Testosterone Treatment181
No Treatment166

[back to top]

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

Interventionchange in standard score (Mean)
Testosterone Treatment2.8
No Treatment2.0

[back to top]

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

Interventionraw score (Mean)
Testosterone Treatment10.5
No Treatment8.9

[back to top]

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

InterventionParticipants (Count of Participants)
Patients with any TEAEPatients with any TEAE related to QSTPatients with SAEPatients with TEAE leading to DiscontinuationPatients with QST related TEAE and discontinuation
Testosterone Enanthate Auto-injector8734484

[back to top]

% 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.

InterventionDifference as % of Mean of T results (Mean)
NAF+EDTANAF+OxalateNAF
Oral Testosterone Undecanoate8.616.623.2

[back to top]

Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks

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 best time. (NCT02679274)
Timeframe: 10 Weeks

Interventionseconds (Number)
Placebo1.08
Testosterone1.01

[back to top]

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

Interventionseconds (Number)
Placebo1.08
Testosterone2.02

[back to top]

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

Interventionkg (Number)
Placebo0.8
Testosterone2.5

[back to top]

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

Interventionmeters/second (Number)
Placebo0.10
Testosterone0.48

[back to top]

Change in Handgrip Strength

Measured using a handgrip dynamometer (NCT02679274)
Timeframe: 0 to 10 Weeks

Interventionkg (Number)
Placebo-5.0
Testosterone5.0

[back to top]

Change in Hip Abduction Strength (Supine)

Collected using a manual muscle tester (MMT). (NCT02679274)
Timeframe: 0 to 10 Weeks

Interventionkg (Number)
Placebo0.9
Testosterone2.6

[back to top]

Change in Knee Extension Strength (Seated)

Collected using a manual muscle tester (MMT). (NCT02679274)
Timeframe: 0 to 10 Weeks

Interventionkg (Number)
Placebo1.7
Testosterone5.9

[back to top]

Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks.

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: 10 Weeks

Interventionseconds (Number)
Placebo10
Testosterone10

[back to top]

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

Interventionseconds (Number)
Placebo0
Testosterone0

[back to top]

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

Interventionseconds (Number)
Placebo10
Testosterone10

[back to top]

Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline

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: baseline

Interventionseconds (Number)
Placebo0
Testosterone10

[back to top]

Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks

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: 10 Weeks

Interventionseconds (Number)
Placebo0
Testosterone2.6

[back to top]

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

Interventionseconds (Number)
Placebo0
Testosterone0

[back to top]

Mean Serum Dihydrotestosterone Cmax

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: 24 hours post-dose in each period

Interventionng/dL (Mean)
TE Period 1 400 mg QDTU Period 2 200 mg QDTU Period 3 100 mg BIDTU Period 4 200 mg BIDTE Period 5 400 mg BID
Testosterone Enanthate and Testosterone Undecanoate14012297.9114127

[back to top]

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

Interventionng/dL (Mean)
TE Period 1 400 mg QDTU Period 2 200 mg QDTU Period 3 100 mg BIDTU Period 4 200 mg BIDTE Period 5 400 mg BID
Testosterone Enanthate and Testosterone Undecanoate293246281385316

[back to top]

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

InterventionParticipants (Count of Participants)
Oral TU Cosyntropin Substudy Subjects19
Axiron Cosyntropin Substudy Subjects8

[back to top]

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

InterventionParticipants (Count of Participants)
Oral Testosterone Undecanoate145
Axiron Testosterone Topical Solution48

[back to top]

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

,
Interventionkilograms (Least Squares Mean)
Total Body Mass at end of Phase 1Total Body Mass at end of Phase 2Total Body Mass at end of Phase 3Fat-free Mass at end of Phase 1Fat-free Mass at end of Phase 2Fat-free Mass at end of Phase 3Fat Mass at end of Phase 1Fat Mass at end of Phase 2Fat Mass at end of Phase 3
Energy Deficit78.373.376.558.358.060.516.812.212.8
Energy Deficit + Testosterone78.075.879.357.960.463.116.812.012.8

[back to top]

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

InterventionParticipants (Count of Participants)
Patients with any TEAEPatients with any TEAE related to QSTPatients with SAEPatients with TEAE leading to discontinuationPatients with QST related TEAE and discontinuation
Testosterone Enanthate Auto-injector51000

[back to top]

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

Interventionng/dL (Geometric Mean)
Breakfast A - Fasting160.0
Breakfast B - 15 g Fat203.7
Breakfast C - 30 g Fat275.1
Breakfast D - 45 g Fat285.1
Breakfast E - High Fat267.3

[back to top]

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

Interventionng*hr/dL (Geometric Mean)
Breakfast A - Fasting1905
Breakfast B - 15 g Fat2428
Breakfast C - 30 g Fat3279
Breakfast D - 45 g Fat3395
Breakfast E - High Fat3187

[back to top]

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

Interventionng/dL (Geometric Mean)
Breakfast A - Fasting250.7
Breakfast B - 15 g Fat334.7
Breakfast C - 30 g Fat529.7
Breakfast D - 45 g Fat506.0
Breakfast E - High Fat463.4

[back to top]

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

Interventionhours (Median)
Breakfast A - Fasting4.000
Breakfast B - 15 g Fat2.000
Breakfast C - 30 g Fat2.000
Breakfast D - 45 g Fat2.000
Breakfast E - High Fat2.000

[back to top]

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

,
InterventionUnits on a scale (Mean)
Effectiveness Domain Change from BaselineConvenience Domain Change from BaselineGlobal Satisfaction Domain Change from Baseline
Natesto Testosterone Intranasal Gel Given BID9.618.9-0.6
Natesto Testosterone Intranasal Gel Given TID21.521.913.3

[back to top]

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

InterventionUnits on a scale (Mean)
Non-naive Patients - BID Treatment4.8
Naive Patients - BID Treatment12.0
Non-naive Patients - TID Treatment3.9
Naive Patients - TID Treatment6.8

[back to top]

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"

,
Interventionng/dl (Number)
visit 2visit 3visit 4vist 5visit 6visit 7
"IM"1043.6785.7NANANANA
"SQ"NANA203.51367.9980.8144.7

[back to top]

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"

,
Interventionnmol/l (Number)
visit 2visit 3visit 4visit 5visit 6visit 7
"IM"25.522NANANANA
"SQ"NANA27.824.822.920.7

[back to top]

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"

,
Interventionmiu/ml (Number)
visit 2visit 3visit 4visit 5visit 6visit 7
"IM"0.40.3NANANANA
"SQ"NANA0.20.040.10.4

[back to top]

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"

,
Interventionmiu/ml (Number)
visit 2visit 3visit 4visit 5visit 6visit 7
"IM"1.30.4NANANANA
"SQ"NANA0.20.10.050.3

[back to top]

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"

,
Interventionpg/mL (Number)
visit 2visit 3visit 4visit 5visit 6visit 7
"IM"70.0352.00NANANANA
"SQ"NANA30.0645.1264.7425.99

[back to top]

Change in Levels of Whole Blood Hematocrit

Blood samples measured by Quest assays and equipment. (NCT03091348)
Timeframe: "Last visit (Visit 7)"

Interventiong/dL (Number)
"SQ"NA
"IM"1.9

[back to top]

Change in Levels of Serum Calculated Free T Concentration

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Last visit ( Visit 7)"

Interventionng/dL (Number)
"SQ"0.84
"IM"14.74

[back to top]

Change in Level of Serum PSA

Blood samples measured by Beckman assays and equipment. (NCT03091348)
Timeframe: "Last visit (Visit 7)"

Interventionng/mL (Number)
"SQ"0.25
"IM"0.02

[back to top]

Mean Change in Level of Luteinizing Hormone in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

InterventionmIU/mL (Mean)
Combination Therapy-3.48

[back to top]

Mean Change in Level of Total Testosterone in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Interventionng/dL (Mean)
Combination Therapy8.26

[back to top]

Mean Change in Level of TSH in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

InterventionuIU/mL (Mean)
Combination Therapy0.37

[back to top]

Mean Change in Total Lean Body Mass

(NCT03123913)
Timeframe: Baseline to 24 weeks

InterventionKg (Mean)
Combination Therapy2.21

[back to top]

Mean Change in Level of Free Testosterone in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Interventionpg/mL (Mean)
Combination Therapy17.42

[back to top]

Mean Change in Level of FSH in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

InterventionmIU/mL (Mean)
Combination Therapy-3.29

[back to top]

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

InterventionParticipants (Count of Participants)
Combination Therapy14

[back to top]

Mean Change in Level of IGF-1 in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Interventionng/mL (Mean)
Combination Therapy89.79

[back to top]

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

InterventionParticipants (Count of Participants)
Natesto32

[back to top]

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

Interventionpg/mL (Mean)
Natesto21.6

[back to top]

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

Interventionmillion sperm/mL (Mean)
Natesto33.9

[back to top]

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

Interventionng/dL (Mean)
Natesto652

[back to top]

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

InterventionmIU/mL (Mean)
Follicle Stimulating HormoneLuteinizing Hormone
Natesto3.02.6

[back to top]

Incidence of Adverse Events

Incidence of adverse events as assessed per treating physician (NCT03203681)
Timeframe: 27 Weeks

InterventionParticipants (Count of Participants)
AzoospermiaSevere OligospermiaNasal irritationsinusitisepistaxis
Natesto13511

[back to top]

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

InterventionPercent of participants (Number)
Oral Testosterone Undecanoate, LPCN 102169

[back to top]

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

InterventionPercent of participants (Number)
Oral Testosterone Undecanoate, LPCN 102180

[back to top]

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

InterventionParticipants (Count of Participants)
Treatment (Olaparib, Testosterone Enanthate or Cypionate)8

[back to top]

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.

InterventionParticipants (Count of Participants)
Treatment (Olaparib, Testosterone Enanthate or Cypionate)14

[back to top]

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

InterventionParticipants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab5

[back to top]

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

Interventionmonths (Number)
Bipolar Androgen Therapy + Nivolumab4.0

[back to top]

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

Interventionpercentage of overall participants (Number)
Bipolar Androgen Therapy + Nivolumab18

[back to top]

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

InterventionParticipants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab18

[back to top]

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

InterventionParticipants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab15

[back to top]

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

Interventionmonths (Median)
Bipolar Androgen Therapy + Nivolumab5.6

[back to top]

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

Interventionmonths (Median)
Bipolar Androgen Therapy + Nivolumab24.4

[back to top]

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)

Interventionbpm (Mean)
LPCN 10210.44

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10211.2

[back to top]

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)

Interventionbpm (Mean)
LPCN 10212.0

[back to top]

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)

InterventionmmHg (Mean)
LPCN 1021-3.0

[back to top]

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)

InterventionmmHg (Mean)
LPCN 1021-1.8

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10212.6

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10214.8

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10211.7

[back to top]

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)

Interventionbpm (Mean)
LPCN 10212.6

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10215.2

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10211.7

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10214.3

[back to top]

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)

Interventionunits on a scale (Mean)
LPCN 10211.2

[back to top]

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

[back to top]

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).

InterventionmmHg (Mean)
LPCN 10213.8

[back to top]

Change in Hematocrit From Baseline

Change in Hematocrit (%) from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to end of Study (approximately 4 months)

Interventionpercentage of hematocrit (Mean)
LPCN 10213.2

[back to top]

Change in Hemoglobin From Baseline

Change in Hemoglobin from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Interventiong/dL (Mean)
LPCN 10210.87

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10211.6

[back to top]

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)

Interventionbpm (Mean)
LPCN 10212.0

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10214.8

[back to top]

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)

InterventionmmHg (Mean)
LPCN 10210.5

[back to top]

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)

Interventionunits on a scale (Mean)
LPCN 1021-0.3

[back to top]

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)

InterventionParticipants (Count of Participants)
LPCN 10212

[back to top]

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

[back to top]

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

[back to top]

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

[back to top]

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)

,
Interventioncm (Least Squares Mean)
Vertical Jump Height, Phase 1Vertical Jump Height, Phase 2Vertical Jump Height, Phase 3
Placebo53.650.050.5
Testosterone54.549.154.0

[back to top]

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)

,
Interventionkg (Least Squares Mean)
Total Mass Lifted, Phase 1Total Mass Lifted, Phase 2Total Mass Lifted, Phase 3
Placebo127.9119.0129.8
Testosterone127.4122.7126.7

[back to top]

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)

,
InterventionL/min (Least Squares Mean)
VO2peak, absolute, Phase 1VO2peak, absolute, Phase 2VO2peak, absolute, Phase 3
Placebo3.283.203.44
Testosterone3.223.133.29

[back to top]

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)

,
Interventionmin (Least Squares Mean)
2.5 mile time, Phase 12.5 mile time, Phase 22.5 mile time, Phase 3
Placebo41.5847.1539.34
Testosterone45.2150.9544.31

[back to top]

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)

,
Interventionkg (Least Squares Mean)
Fat-free Mass at end of Phase 1Fat-free Mass at end of Phase 2Fat-free Mass at end of Phase 3Fat Mass at end of Phase 1Fat Mass at end of Phase 2Fat Mass at end of Phase 3
Placebo59.857.959.617.514.415.5
Testosterone59.259.659.517.313.015.1

[back to top]

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)

,
InterventionW (Least Squares Mean)
Wingate peak power, absolute, Phase 1Wingate peak power, absolute, Phase 2Wingate peak power, absolute, Phase 3
Placebo837.8736.0790.8
Testosterone879.4753.8821.8

[back to top]

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

InterventionPercentage change (Least Squares Mean)
Treatment A2.75
Treatment B1.90
Treatment C-1.42

[back to top]

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

InterventionParticipants (Count of Participants)
Treatment A9
Treatment B8
Treatment C2

[back to top]

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

InterventionParticipants (Count of Participants)
Treatment A12
Treatment B6
Treatment C5

[back to top]

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

InterventionParticipants (Count of Participants)
Treatment A6
Treatment B8
Treatment C3

[back to top]

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

InterventionParticipants (Count of Participants)
Treatment A4
Treatment B2
Treatment C6

[back to top]

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

InterventionPercentage change (Least Squares Mean)
Treatment A-3.68
Treatment B-7.33
Treatment C1.78

[back to top]

Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment 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, fibrosis state 0-4, and NAS 0-8. (NCT04134091)
Timeframe: Baseline and Week 36

,,
InterventionNAS score (Least Squares Mean)
Hepatocyte ballooning scoreLobular inflammation scoreSteatosis 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

[back to top]

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

InterventionParticipants (Count of Participants)
Treatment A6
Treatment B9
Treatment C0

[back to top]

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

InterventionParticipants (Count of Participants)
Treatment A7
Treatment B9
Treatment C1

[back to top]

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

InterventionPercentage of liver fat (Least Squares Mean)
Treatment A-7.68
Treatment B-9.17
Treatment C-1.54

[back to top]

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

,,
Interventionmg/dL (Least Squares Mean)
Total CholesterolLDLHDLTriglycerides
Treatment A-1.71.8-3.3-11.5
Treatment B7.38.7-2.0-3.9
Treatment C1.1-6.0-0.067.3

[back to top]

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

InterventionPercentage change (Least Squares Mean)
Treatment A-39.94
Treatment B-46.84
Treatment C-9.34

[back to top]

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

,,
InterventionU/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 C1.30.60.10.7

[back to top]

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

,
Interventionng/dL (Mean)
Testosterone17-OHP
Natesto Group283-8.8
Testosterone Cypionate Group511-39.8

[back to top]

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

Interventionscore on a scale (Mean)
Testosterone Cypionate Group4.8
Natesto Group0.2

[back to top]

Change in PSA Levels

Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL. (NCT04439799)
Timeframe: Baseline to 4 months

Interventionng/mL (Mean)
Testosterone Cypionate Group0.6
Natesto Group0.05

[back to top]

Change in Hematocrit (Hct) Levels.

Changes in serum Hematocrit levels will be assessed in percentage (NCT04439799)
Timeframe: Baseline to 4 months

Interventionpercentage of hematocrit (Mean)
Testosterone Cypionate Group3.0
Natesto Group-0.6

[back to top]

Change in Estradiol Levels

Change in serum estradiol levels will be assessed in pg/mL. (NCT04439799)
Timeframe: Baseline to 4 months

Interventionpg/mL (Mean)
Testosterone Cypionate Group22.9
Natesto Group1.1

[back to top]

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

,
Interventionng/dL (Median)
BaselineMonth 2Month 4Month 6
Compounded Testosterone Pellets 100mg Group202.3696.5277241
Testopel 75mg Group219.5543290209

[back to top]

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

,
Interventionng/mL (Median)
BaselineMonth 2Month 4Month 6
Compounded Testosterone Pellets 100mg Group0.40.750.650.5
Testopel 75mg Group0.91.110.8

[back to top]

Change in Hematocrit (Hct) Levels.

Changes in serum Hct levels are assessed in %. (NCT04523480)
Timeframe: Baseline, 2 months, 4 months, and 6 months

,
Interventionhematocrit percentage (Median)
BaselineMonth 2Month 4Month 6
Compounded Testosterone Pellets 100mg Group42.846.745.843
Testopel 75mg Group43.746.145.946

[back to top]

Change in Estradiol Levels

Change in serum estradiol levels are assessed in pg/mL. (NCT04523480)
Timeframe: Baseline, 2 months, 4 months, and 6 months

,
Interventionpg/mL (Median)
BaselineMonth 2Month 4Month 6
Compounded Testosterone Pellets 100mg Group20.642.718.418.8
Testopel 75mg Group18.229.113.714.3

[back to top]

Serum Estradiol Levels

Serum estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw. (NCT04983940)
Timeframe: Up to 6 months

Interventionpg/mL (Mean)
BaselineMonth 3Month 6
Jatenzo Arm14.421.621.2

[back to top]

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

Interventionng/mL (Mean)
BaselineMonth 3Month 6
Jatenzo Arm1.061.140.95

[back to top]

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

Interventionscore on a scale (Mean)
BaselineMonth 3Month 6
Jatenzo Arm66.783.183.7

[back to top]

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

Interventionscore on a scale (Mean)
BaselineMonth 3Month 6
Jatenzo Arm36.634.435.5

[back to top]

Hematocrit Levels

Hematocrit levels measured as a percentage analyzed from peripheral venous puncture blood draw. (NCT04983940)
Timeframe: Up to 6 months

Interventionpercentage of hematocrit (Mean)
BaselineMonth 3Month 6
Jatenzo Arm44.94545.2

[back to top]

Serum Testosterone Levels

Serum testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw (NCT04983940)
Timeframe: Up to 6 months

Interventionng/dL (Mean)
BaselineMonth 3Month 6
Jatenzo Arm200.3486.8649.3

[back to top]