testosterone undecanoate profile

ID Source	ID
PubMed CID	65157
CHEMBL ID	2107067
CHEBI ID	135741
SCHEMBL ID	147620
MeSH ID	M0056567

Synonym
restandol
pantestone
androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17-beta)
andriol (tn)
5949-44-0
aveed (tn)
D06087
testosterone undecanoate (usan)
androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17-beta)-
testosterone, undecanoate (ester)
17beta-hydroxyandrost-4-en-3-one undecanoate
einecs 227-712-6
5-alpha-androstan-3-one, 17-beta-hydroxy-, undecanoate
brn 3176734
undestor
t undecanoate
org 538
testosterone undecanoate
3-oxoandrost-4-en-17beta-yl undecanoate
androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-(17beta)
testosterone undecanoate [usan]
nebido
andriol
testosterone undecylate
CHEBI:135741
[(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] undecanoate
4-08-00-00981 (beilstein handbook reference)
nebido-r
reandron 1000
bay 86-5037
clr-610
testosterone undeconate
h16a5vct9c ,
jatenzo
androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17beta)-
aveed
unii-h16a5vct9c
rextoro
testosterone 17.beta.-undecylate
CHEMBL2107067
kyzatrex
tsx-011
org-538
mk-3033
AKOS016010255
tlando
(17.beta.)-17-hydroxyandrost-4-en-3-one undecanoate
.delta.(sup 4)-androsten-17.beta.-ol-3-one undecanoate
testosterone undecanoate [mi]
3-oxoandrost-4-en-17.beta.-yl undecanoate
testosterone undecylate [mart.]
testosterone undecanoate [vandf]
androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-(17beta)
testosterone undecanoate [who-dd]
17.beta.-hydroxyandrost-4-en-3-one undecanoate
testosterone undecanoate [orange book]
SCHEMBL147620
CS-4342
(17-beta)-3-oxoandrost-4-en-17-yl undecanoate
(17beta)-3-oxoandrost-4-en-17-yl undecanoate
W-105318
testosterone, undecanoate
androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17.beta.)-
5-.alpha.-androstan-3-one, 17-.beta.-hydroxy-, undecanoate
HY-B0626
testosterone (undecanoate) ,
(1s,2r,10r,11s,14s,15s)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl undecanoate
GS-6598
(1s,2r,10r,11s,14s,15s)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0?,?.0??,??]heptadec-6-en-14-yl undecanoate
DB13946
BCP11921
Q15410178
NCGC00484056-01
androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17b)-
17beta-undecanoyloxy-4-androsten-3-one
DTXSID90863661
(17beta)-17-hydroxyandrost-4-en-3-one undecanoate
delta(sup 4)-androsten-17beta-ol-3-one undecanoate
testosterone undecylate (mart.)
testosterone 17beta-undecylate
testosterone 17-undecanoate

Excerpt	Reference	Relevance
"Testosterone undecanoate is a hormone agent with long-acting potential and is used for testosterone replacement therapy for hypogonadism. "	( Comparative application of testosterone undecanoate and/or testosterone propionate in induction of benign prostatic hyperplasia in Wistar rats. An, J; Kong, H, 2022)	2.46
"And testosterone undecanoate is an effective and safe supplementary therapy for LOH."	( [Testosterone undecanoate for late -onset hypogonadism: an update]. Fan, XB; Huang, YF, 2010)	1.75
"Testosterone undecanoate is a potentially valuable drug for the oral treatment of male hypogonadism."	( Clinical efficacy of testosterone undecanoate in male hypogonadism. Bingham, J; Chakraborty, J; English, J; Maisey, NM; Marks, V, 1981)	1.3
"Testosterone undecanoate is a safe, well tolerated, and effective treatment in the management of constitutional delay of growth."	( A double blind, placebo controlled study of the effects of low dose testosterone undecanoate on the growth of small for age, prepubertal boys. Brown, DC; Butler, GE; Kelnar, CJ; Wu, FC, 1995)	1.25
"Testosterone undecanoate (Andriol) is an oral androgen that provides the hypogonadal patient with the unmodified testosterone molecule. "	( A ten-year safety study of the oral androgen testosterone undecanoate. Gooren, LJ, )	1.83
"Testosterone undecanoate is an effective agent for treating hypogonadism. "	( Testosterone supplementation for hypogonadal impotence: assessment of biochemical measures and therapeutic outcomes. Heaton, JP; Johnston, B; Lundie, M; Morales, A, 1997)	1.74

Excerpt	Reference	Relevance
"Testosterone undecanoate (TU) has potential as androgen therapy for ovariectomized female to male (FtM) transsexual subjects; however, the long-term physiologic effects of TU treatment, the significance of testosterone (T), and the T metabolites dihydrotestosterone (DHT) and estradiol (E) on specific outcome parameters are currently unknown."	( Effects of testosterone undecanoate administered alone or in combination with letrozole or dutasteride in female to male transsexuals. Altieri, P; Armillotta, F; Costantino, A; Ghi, T; Kalhorn, T; Meriggiola, MC; Pelusi, C; Pelusi, G; Perrone, AM; Saad, F, 2008)	2.18
"Testosterone undecanoate has been available on the market for more than 20 years. "	( A new oral testosterone undecanoate formulation. Köhn, FM; Schill, WB, 2003)	2.15

Excerpt	Reference	Relevance
"Testosterone undecanoate (T) treatment is common in female-to-male transsexuals (FtMs) but can induce impairment of mitochondrial function and oxidative stress."	( Mitochondrial impairment and oxidative stress in leukocytes after testosterone administration to female-to-male transsexuals. Bañuls, C; Gómez, M; Hernández-Mijares, A; Rocha, M; Rovira-Llopis, S; Victor, VM, 2014)	1.85
"Testosterone undecanoate treatment (n = 33) significantly improved sexual dysfunction and symptom scores of metabolic, cardiopulmonary, musculoskeletal and gastrointestinal functions compared to baseline and to placebo (n = 6)."	( Oral testosterone undecanoate (Andriol) supplement therapy improves the quality of life for men with testosterone deficiency. Chung, JM; Lee, KM; Park, NC; Yan, BQ, 2003)	1.55

Excerpt	Reference	Relevance
" These data provide evidence that TU is a reasonably safe form of oral androgen therapy."	( Long-term safety of the oral androgen testosterone undecanoate. Gooren, LJ, 1986)	0.54
" Testosterone undecanoate appears to be a safe oral androgen."	( A ten-year safety study of the oral androgen testosterone undecanoate. Gooren, LJ, )	1.3
" No adverse effects regarding the prostate were observed."	( Androgen receptor gene CAG repeat length and body mass index modulate the safety of long-term intramuscular testosterone undecanoate therapy in hypogonadal men. Nieschlag, E; Zitzmann, M, 2007)	0.55
" Adverse observations are mostly seen in obese patients."	( Androgen receptor gene CAG repeat length and body mass index modulate the safety of long-term intramuscular testosterone undecanoate therapy in hypogonadal men. Nieschlag, E; Zitzmann, M, 2007)	0.55
"TU appears to be a stable and safe treatment modality of hypogonadal men."	( A four-year efficacy and safety study of the long-acting parenteral testosterone undecanoate. Ernst, M; Freude, S; Gouni-Berthold, I; Hübler, D; Jockenhövel, F; Krone, W; Mellinger, U; Minnemann, T; Oettel, M; Schubert, M; Schumann, C; Sommer, F, 2007)	0.58
" No major adverse event due to T treatment occurred."	( Efficacy and safety of two different testosterone undecanoate formulations in hypogonadal men with metabolic syndrome. Aversa, A; Bruzziches, R; Francomano, D; Lenzi, A; Spera, G, 2010)	0.63
" TU was safe over 12 months and discontinuation rates were similar to placebo."	( Efficacy and safety of two different testosterone undecanoate formulations in hypogonadal men with metabolic syndrome. Aversa, A; Bruzziches, R; Francomano, D; Lenzi, A; Spera, G, 2010)	0.63
" No serious adverse reactions were observed."	( The efficacy and safety of testosterone undecanoate (Nebido(®)) in testosterone deficiency syndrome in Korean: a multicenter prospective study. Ahn, TY; Kim, JJ; Kim, SW; Lee, JY; Lee, SW; Moon, DG; Paick, JS; Park, JK; Park, K; Park, MG; Park, NC; Seo, JT; Yang, DY, 2010)	0.66
" Priapism events and adverse drug events were assessed every 3 months."	( Testosterone replacement therapy does not promote priapism in hypogonadal men with sickle cell disease: 12-month safety report. Burnett, AL; Madden, W; Morrison, BF; Reid, M, 2013)	0.39
" Participants were seen six times in the 48-week period and the following data were collected: physical examination results, haemoglobin, haematocrit, TT, lipid profile, fasting blood glucose, sex hormone-binding globulin, liver function test, prostate- specific antigen (PSA) and adverse events."	( Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study. Ho, C; Khoo, EM; Lee, BC; Lee, G; Lee, V; Low, WY; Ng, CJ; Tan, HM; Tan, WK; Tan, WS; Tong, SF, 2013)	0.64
" Common adverse events observed in the treatment arm included itching/swelling/pain at the site of injection, flushing and acne."	( Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study. Ho, C; Khoo, EM; Lee, BC; Lee, G; Lee, V; Low, WY; Ng, CJ; Tan, HM; Tan, WK; Tan, WS; Tong, SF, 2013)	0.64
" PSA, haemoglobin and haematocrit were significantly elevated but were within clinically safe limits."	( Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study. Ho, C; Khoo, EM; Lee, BC; Lee, G; Lee, V; Low, WY; Ng, CJ; Tan, HM; Tan, WK; Tan, WS; Tong, SF, 2013)	0.64
"The aim of this study is to report the short-term effects of CHT on hormonal and clinical changes, side effects, and adverse events in trans men (female-to-male gender dysphoric persons) and trans women (male-to-female gender dysphoric persons)."	( Cross-sex hormone therapy in trans persons is safe and effective at short-time follow-up: results from the European network for the investigation of gender incongruence. Fisher, A; Fisher, AD; Haraldsen, I; Kaufman, JM; Schreiner, T; T'Sjoen, G; Toye, K; Van Caenegem, E; Wierckx, K, 2014)	0.4
" Side effects, adverse events, and desired clinical changes were examined."	( Cross-sex hormone therapy in trans persons is safe and effective at short-time follow-up: results from the European network for the investigation of gender incongruence. Fisher, A; Fisher, AD; Haraldsen, I; Kaufman, JM; Schreiner, T; T'Sjoen, G; Toye, K; Van Caenegem, E; Wierckx, K, 2014)	0.4
"No deaths or severe adverse events were observed."	( Cross-sex hormone therapy in trans persons is safe and effective at short-time follow-up: results from the European network for the investigation of gender incongruence. Fisher, A; Fisher, AD; Haraldsen, I; Kaufman, JM; Schreiner, T; T'Sjoen, G; Toye, K; Van Caenegem, E; Wierckx, K, 2014)	0.4
"Current treatment modalities were effective and carried a low risk for side effects and adverse events at short-time follow-up."	( Cross-sex hormone therapy in trans persons is safe and effective at short-time follow-up: results from the European network for the investigation of gender incongruence. Fisher, A; Fisher, AD; Haraldsen, I; Kaufman, JM; Schreiner, T; T'Sjoen, G; Toye, K; Van Caenegem, E; Wierckx, K, 2014)	0.4
"TU could significantly increase the serum testosterone level and improve the clinical symptoms of LOH patients without inducing serious adverse reactions."	( [Effect and safety of testosterone undecanoate in the treatment of late-onset hypogonadism: a meta-analysis]. Ma, J; Shang, XJ; Shen, XB; Shi, YJ; Zheng, Y; Zhou, YZ, 2015)	0.73
"The development of a safe and effective reversible method of male contraception is still an unmet need."	( Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men. Anderson, RA; Behre, HM; Callahan, MM; Colvard, DS; Festin, MP; Habib, NA; Handelsman, DJ; Lestari, SW; Linton, KA; McLachlan, RI; Meriggiola, MC; Misro, MM; Noe, G; Vogelsong, KM; Wu, FC; Zitzmann, M, 2016)	0.43
" The most common adverse events were acne, injection site pain, increased libido, and mood disorders."	( Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men. Anderson, RA; Behre, HM; Callahan, MM; Colvard, DS; Festin, MP; Habib, NA; Handelsman, DJ; Lestari, SW; Linton, KA; McLachlan, RI; Meriggiola, MC; Misro, MM; Noe, G; Vogelsong, KM; Wu, FC; Zitzmann, M, 2016)	0.43
" 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)	1.92
"Oral TU offers a safe and effective long-term treatment option for men with hypogonadism."	( Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. Amory, JK; Dudley, RE; Gittelman, M; Honig, S; Kaminetsky, J; Newmark, J; Rohowsky, N; Swerdloff, R; Wang, C; Woun Seo, B, 2022)	1

Excerpt	Reference	Relevance
" 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)	0.87
" Pharmacokinetic analysis showed a terminal elimination half-life of 18."	( A pharmacokinetic study of injectable testosterone undecanoate in hypogonadal men. Bremner, WJ; Cui, YG; Gu, YQ; Wang, XH; Zhang, GY, )	0.4
" Mean serum testosterone, area under the curve (AUC), and terminal half-life were calculated."	( Oral testosterone-triglyceride conjugate in rabbits: single-dose pharmacokinetics and comparison with oral testosterone undecanoate. Amory, DW; Amory, JK; Bremner, WJ; Scriba, GK, )	0.34
"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
"To assess the pharmacokinetic parameters of testosterone undecanoate after administration of a new oral formulation, Andriol Testocaps."	( Pharmacokinetic study in women of three different doses of a new formulation of oral testosterone undecanoate, Andriol Testocaps. Bagchus, WM; Houwing, NS; Maris, F; Schnabel, PG, 2003)	0.8
" Pharmacokinetic parameters were calculated using standard methods."	( Pharmacokinetic study in women of three different doses of a new formulation of oral testosterone undecanoate, Andriol Testocaps. Bagchus, WM; Houwing, NS; Maris, F; Schnabel, PG, 2003)	0.54
" The current objective was to develop a population pharmacokinetic (PK) model for intramuscular testosterone undecanoate 750 mg and to perform PK simulations to assess the impact of an 8-week maintenance regimen on testosterone exposure."	( Population Pharmacokinetic Modeling and Simulations to Evaluate a Potential Dose Regimen of Testosterone Undecanoate in Hypogonadal Males. Bush, M; Curd, L; Hu, Y; Pastuszak, AW; Priestley, T; Vijayan, S; Xiang, Q, 2021)	1.06

Excerpt	Reference	Relevance
" with 12 mg/kg testosterone undecanoate (TU) twice in the first and once in each of the succeeding 2 months in combination with oral danazol (DZ) of 30 mg/kg/day."	( [Studies on antifertility effect of testosterone undecanoate in combination with danazol in male rats]. Lu, ZL, 1989)	0.9
" As a prerequisite for a planned multicenter male contraceptive efficacy study, we studied the pharmacokinetics of 2 doses of TU alone or in combination with norethisterone enanthate (NETE) in a prospective 2-center study, randomized for TU dose in each center."	( Pharmacokinetics of testosterone undecanoate injected alone or in combination with norethisterone enanthate in healthy men. Cerpolini, S; Christensen, PD; Hull, L; Lumbreras, L; Meriggiola, C; Ng, CM; Pelusi, G; Qoubaitary, A; Swerdloff, RS; Wang, C, )	0.45
"Treatment with injectable testosterone undecanoate (TU) alone or in combination with oral levonorgestrel (LNG) resulted in marked decreases in sperm concentrations."	( Proteomic analysis of testis biopsies in men treated with injectable testosterone undecanoate alone or in combination with oral levonorgestrel as potential male contraceptive. Cui, Y; Guo, X; Hikim, AS; Huo, R; Jia, Y; Lue, YH; Qian, L; Sha, J; Swerdloff, RS; Tong, J; Wang, C; Wang, X; Zhou, Z; Zhu, H; Zhu, Y, 2008)	0.88
"To observe the clinical effect of low-dose testosterone undecanoate capsules combined with tadalafil on late-onset hypogonadism (LOH) accompanied with ED."	( [Low-dose testosterone undecanoate capsules combined with tadalafil for late-onset hypogonadism accompanied with ED]. Huang, CC; Li, GY; Liang, JH; Liang, SK; Meng, ZB; Shen, SL; Song, WR; Wei, GQ; Zhang, X; Zhu, CH, 2013)	1.05
"Ninety cases of LOH accompanied with ED who met the inclusion criteria were randomly divided into a control group and a combination therapy group, the former treated with tadalafil and the latter with low-dose testosterone undecanoate capsules combined with tadalafil."	( [Low-dose testosterone undecanoate capsules combined with tadalafil for late-onset hypogonadism accompanied with ED]. Huang, CC; Li, GY; Liang, JH; Liang, SK; Meng, ZB; Shen, SL; Song, WR; Wei, GQ; Zhang, X; Zhu, CH, 2013)	0.98
"Low-dose testosterone undecanoate capsules combined with tadalafil has a definite clinical effect and no obvious adverse reactions in the treatment of LOH accompanied with ED."	( [Low-dose testosterone undecanoate capsules combined with tadalafil for late-onset hypogonadism accompanied with ED]. Huang, CC; Li, GY; Liang, JH; Liang, SK; Meng, ZB; Shen, SL; Song, WR; Wei, GQ; Zhang, X; Zhu, CH, 2013)	1.21
"To investigate the clinical effects of oral Testosterone Undecanoate Capsules (TUC) combined with Qilin Pills (QLP) on late-onset hypogonadism (LOH) in men."	( [Oral Testosterone Undecanoate Capsules combined with Qilin Pills for late-onset hypogonadism in males]. Chen, XG; Gui, DW; Mao, JB; Peng, W; Zheng, J, 2017)	1.2
"TUC combined with Qilin Pills has a better effect and a lower rate of adverse reactions than TUC used alone in the treatment of late-onset hypogonadism in males."	( [Oral Testosterone Undecanoate Capsules combined with Qilin Pills for late-onset hypogonadism in males]. Chen, XG; Gui, DW; Mao, JB; Peng, W; Zheng, J, 2017)	0.94
"To evaluate the efficacy and safety of Jiarong Tablets (JRT) combined with Testosterone Undecanoate Capsules (TUC) in the treatment of late-onset hypogonadism (LOH) in males."	( [Jiarong Tablets combined with Testosterone Undecanoate Capsules for late-onset hypogonadism in males: A multicentered clinical trial]. Geng, Q; Hao, BJ; Li, YZ; Liang, WN; Shang, XJ; Wu, M, 2020)	1.07
"JRT combined with TUC is safe and effective and superior to TUC alone in the treatment of LOH in males."	( [Jiarong Tablets combined with Testosterone Undecanoate Capsules for late-onset hypogonadism in males: A multicentered clinical trial]. Geng, Q; Hao, BJ; Li, YZ; Liang, WN; Shang, XJ; Wu, M, 2020)	0.84

Excerpt	Reference	Relevance
" The study shows that testosterone undecanoate is well absorbed from the gut and releases significantly elevated amounts of testosterone which is available to target tissues."	( Saliva and serum testosterone following oral testosterone undecanoate administration in normal and hypogonadal men. Freischem, CW; Nieschlag, E; Schürmeyer, T; Wickings, EJ, 1983)	0.84
"To assess the effects of food on the bioavailability of testosterone undecanoate, testosterone, and 5alpha-dihydrotestosterone (DHT) after administration of a new oral testosterone undecanoate formulation, Andriol Testocaps."	( Important effect of food on the bioavailability of oral testosterone undecanoate. Bagchus, WM; Houwing, NS; Hust, R; Maris, F; Schnabel, PG, 2003)	0.81
"Food increases the bioavailability of testosterone undecanoate, testosterone, and DHT."	( Important effect of food on the bioavailability of oral testosterone undecanoate. Bagchus, WM; Houwing, NS; Hust, R; Maris, F; Schnabel, PG, 2003)	0.84
" However, there are no definitive data regarding the oral bioavailability of TU or the extent to which lymphatically transported TU contributes to the systemic availability of T after oral TU administration."	( Contribution of lymphatically transported testosterone undecanoate to the systemic exposure of testosterone after oral administration of two andriol formulations in conscious lymph duct-cannulated dogs. Charman, WN; Edwards, GA; Faassen, WA; Houwing, N; Lass, H; Porter, CJ; Shackleford, DM, 2003)	0.58
" And the bioavailability was compared to a marketed product."	( Production and characterization of testosterone undecanoate-loaded NLC for oral bioavailability enhancement. Keck, CM; Maincent, P; Muchow, M; Müller, RH, 2011)	0.65
"Nanostructured lipid carriers with up to 30% TU load and sizes of about 600 and 200 nm could be achieved, allowing a direct comparison of the size effect in in vivo bioavailability studies."	( Production and characterization of testosterone undecanoate-loaded NLC for oral bioavailability enhancement. Keck, CM; Maincent, P; Muchow, M; Müller, RH, 2011)	0.65
"This opens the perspective of administering a single dose of dose of TU in one oral dosage unit and simultaneously having a bioavailability less dependent on the fed state."	( Production and characterization of testosterone undecanoate-loaded NLC for oral bioavailability enhancement. Keck, CM; Maincent, P; Muchow, M; Müller, RH, 2011)	0.65
" It was expected to improve the dissolution and oral bioavailability of TU, as a result of investigating the feasibility of the clinical application of SEDDS."	( Solid Self-Emulsifying Drug Delivery System (Solid SEDDS) for Testosterone Undecanoate: In Vitro and In Vivo Evaluation. Gao, J; Hua, Y; Li, Z; Liang, X; Liu, Q; Yu, F; Zhang, H; Zheng, A, 2021)	0.86

Excerpt	Relevance	Reference
"In 35 men treated with testosterone undecanoate (TU) at a dosage of 80-200 mg/day, liver function was measured every 6 months for a period of 72 months."	( Long-term safety of the oral androgen testosterone undecanoate. Gooren, LJ, 1986)	0.85
" Mean serum i-FSH levels were decreased by TU injection at both doses without dose-response effects."	( Quantitative and qualitative changes in serum luteinizing hormone after injectable testosterone undecanoate treatment in hypogonadal men. Bremner, WJ; Ge, ZY; Gu, YQ; Zhang, GY, 2000)	0.53
" The dosage was then decreased to 80 mg daily and changes in symptoms were assessed at every visit."	( Oral testosterone replacement in Korean patients with PADAM. Ahn, TY; Hong, JH, 2002)	0.31
"The castrated rats were given high and low dosage Andriol respectively, compared with intact and castrated rats."	( [The effects of testosterone undecanoate on relaxation of rat corpus cavernosum smooth muscle in vitro]. Han, YF; Li, Z; Wang, YX; Xiang, ZQ; Zheng, S, 2002)	0.66
"Two oral doses each of testosterone undecanoate 20, 40, or 80 mg were administered with meals, separated by a 12-hour dosing interval."	( Pharmacokinetic study in women of three different doses of a new formulation of oral testosterone undecanoate, Andriol Testocaps. Bagchus, WM; Houwing, NS; Maris, F; Schnabel, PG, 2003)	0.85
" Results demonstrated that the combined dosage regimen could damage epididymal sperm motility and density, and induce infertility within 8 weeks in rats; the infertility could be consistently sustained by giving single GA (12."	( Combined administration of low-dose gossypol acetic acid with desogestrel/mini-dose ethinylestradiol/testosterone undecanoate as an oral contraceptive for men. Cui, GH; Guo, Y; Xue, SP; Yang, ZJ; Ye, WS, 2004)	0.54
"The lower combined dosage is recommended for further testing in an expanded clinical trial or contraceptive efficacy study."	( [Effect of injection of testosterone undecanoate and depot medroxyprogesterone acetate on the suppression of spermatogenesis]. Bremner, WJ; Chen, Z; Gu, Y; Ma, D; Tang, W; Tong, J; Wang, X; Yuan, D, 2004)	0.63
" An initial loading dose of either 3 x 1000 mg TU every 6 wk at the beginning of hormone substitution or 2 x 1000 mg TU every 8 wk after switching from the short-acting TE to TU were found to be a adequate dosing regimens for starting of treatment with the long-acting TU preparation."	( Intramuscular testosterone undecanoate: pharmacokinetic aspects of a novel testosterone formulation during long-term treatment of men with hypogonadism. Christoph, A; Ernst, M; Hübler, D; Jockenhövel, F; Krone, W; Mellinger, U; Minnemann, T; Oettel, M; Rouskova, D; Schubert, M, 2004)	0.68
"Serial blood samples were collected until 24 h after dosing to determine testosterone and dihydrotestosterone (DHT) by gas chromatography-mass spectroscopy (GC-MS)."	( The effect of food composition on serum testosterone levels after oral administration of Andriol Testocaps. Bagchus, W; Geurts, TB; Lass, H; Schnabel, PG; Thomsen, T, 2007)	0.34
"The objective of this study was to observe the dose-response effects of testosterone (T) treatment on symptoms of sexual dysfunction and the metabolic syndrome."	( A dose-response study of testosterone on sexual dysfunction and features of the metabolic syndrome using testosterone gel and parenteral testosterone undecanoate. Gooren, LJ; Haider, A; Saad, F; Yassin, A, )	0.33
" Testosterone gels minimize the skin irritation while providing flexibility in dosing and a low discontinuation rate."	( Recent trends in the treatment of testosterone deficiency syndrome. Ahn, TY; Hong, BS, 2007)	0.34
" The study was performed in 43 centres in Austria and a dosage of oral testosterone undecanoate of 2 x 80 mg/day was used for three months."	( Clinical experience with Andriol Testocaps--the first Austrian surveillance study on the treatment of late-onset hypogonadism. Geurts, P; Jungwirth, A; Plas, E, 2007)	0.57
"Oral testosterone undecanoate supplementation, in dosage of 160 mg daily for 26 weeks, does not increase hs-CRP levels in elderly men."	( Oral testosterone supplementation and chronic low-grade inflammation in elderly men: a 26-week randomized, placebo-controlled trial. Bots, ML; Emmelot-Vonk, MH; Grobbee, DE; Nakhai-Pour, HR; van der Schouw, YT; Verhaar, HJ, 2007)	0.85
" At week 18 age and body size correlated with the cBioT and TT and this may then be used to estimate dosing frequency for this therapy."	( Serum testosterone and bioavailable testosterone correlate with age and body size in hypogonadal men treated with testosterone undecanoate (1000 mg IM--Nebido). Moisey, R; Orme, S; Swinburne, J, 2008)	0.56
"46 ng/dl during the 70-day dosing interval and mean +/- SD maximum serum testosterone was 890."	( Long acting testosterone undecanoate therapy in men with hypogonadism: results of a pharmacokinetic clinical study. Dobs, AS; Kaufman, JM; Miner, MM; Morgentaler, A; Shabsigh, R; Swerdloff, RS; Wang, C, 2008)	0.72
"This 24-week clinical study demonstrated that 750 mg testosterone undecanoate depot injection administered intramuscularly at 0, 4 and 14 weeks achieves serum testosterone levels in the normal range during a 10-week dosing interval."	( Long acting testosterone undecanoate therapy in men with hypogonadism: results of a pharmacokinetic clinical study. Dobs, AS; Kaufman, JM; Miner, MM; Morgentaler, A; Shabsigh, R; Swerdloff, RS; Wang, C, 2008)	0.97
"Testosterone undecanoate (TU) represents an exciting new testosterone replacement therapy for hypogonadal men due to its convenient dosing schedule and favorable pharmacokinetic and safety profiles."	( Testosterone undecanoate in the treatment of male hypogonadism. Basaria, S; Edelstein, D, 2010)	3.25
" Patient preference for the convenient dosing schedule might also lead to better compliance and therapeutic benefit."	( Testosterone undecanoate in the treatment of male hypogonadism. Basaria, S; Edelstein, D, 2010)	1.8
" On the seventh day of each dosing period, serum testosterone, DHT and oestradiol were measured at baseline and 1, 2, 4, 8, 12, 13, 14, 16, 20 and 24 h after the morning dose."	( Steady-state pharmacokinetics of oral testosterone undecanoate with concomitant inhibition of 5α-reductase by finasteride. Amory, JK; Christenson, P; Dudley, RE; Hull, L; Leung, A; Roth, MY; Swerdloff, R; Wang, C, 2011)	0.64
" The weight gain of the highest NETE plus TU dosage was mainly because of gain in muscle mass."	( A placebo-controlled, randomized clinical trial using testosterone undecanoate with injectable norethisterone enanthate: effect on anthropometric, metabolic and biochemical parameters. Cerpolini, S; Costantino, A; Meriggiola, MC; Pasquali, R; Pelusi, C; Pelusi, G, 2011)	0.62
"This opens the perspective of administering a single dose of dose of TU in one oral dosage unit and simultaneously having a bioavailability less dependent on the fed state."	( Production and characterization of testosterone undecanoate-loaded NLC for oral bioavailability enhancement. Keck, CM; Maincent, P; Muchow, M; Müller, RH, 2011)	0.65
" Pharmacokinetics studies were conducted in 3 parts: 12 hypogonadal men were enrolled in 2 centers for a 1-day dosing study; 29 participants were enrolled from 3 centers for a 7-day dosing study; and 15 participants were enrolled from 1 center for a 28-day dosing study."	( Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. Baravarian, S; Bross, R; Diaz-Arjonilla, M; Dudley, RE; Faulkner, S; Flippo, G; Htun, M; Hull, L; Kulback, S; Leung, A; Longstreth, JA; Swerdloff, RS; Wang, C; Yin, AY, )	0.4
"5 mg×kg(-1)×d(-1)) was given; group H, the same dosage of DSG/EE/TU as in group GH were administered; group C, rats were treated with vehicle (1% methyl cellulose) as control."	( Drug synergistic antifertility effect of combined administration of low-dose gossypol with steroid hormones in rats. Chang, Q; Hei, CC; Liu, Z; Ma, WZ; Qian, XJ; Shen, XS; Xu, ZL, 2011)	0.37
" Additional outcome measures were changes in the dosing and/or interval regimens for TUD therapy."	( Retrospective investigation of testosterone undecanoate depot for the long-term treatment of male hypogonadism in clinical practice. Conaglen, HM; Conaglen, JV; Elston, MS; Kamp, J; Paul, RG; Yarndley, T, 2014)	0.69
" At 2 years, 91% of men received the standard 1,000 mg TUD dose with 66% at the standard dosing interval of 10-14 weekly."	( Retrospective investigation of testosterone undecanoate depot for the long-term treatment of male hypogonadism in clinical practice. Conaglen, HM; Conaglen, JV; Elston, MS; Kamp, J; Paul, RG; Yarndley, T, 2014)	0.69
" Optimal dosing may be less than 10 weeks for some individuals."	( Initial Clinical Experience With Testosterone Undecanoate Therapy (AVEED) in Men With Testosterone Deficiency in the United States. Conners, W; Davidson, E; Krakowsky, Y; Morgentaler, A; Rawji, A, 2017)	0.74
" However, there is no consensus on the optimal timing, dosage and dosage interval of testosterone therapy to induce pubertal development and achieve a normal adult height and bone mass in children with hypogonadism."	( Growth, sexual and bone development in a boy with bilateral anorchia under testosterone treatment guided by the development of his monozygotic twin. Craen, M; Kaufman, JM; T'Sjoen, G; Taes, Y; Van Caenegem, E; Vandewalle, S, 2018)	0.48
" The results provide a rationale for individualizing hormone therapy in transmen, by considering individual effects rather than solely relying on a standardized dosage of hormone therapy."	( Variation in sensitivity and rate of change in body composition: steps toward individualizing transgender care. Conemans, EB; den Heijer, M; Nota, NM; Simsek, S; T'Sjoen, G; van Velzen, DM, 2020)	0.56
" However, a more frequent maintenance regimen may improve symptom management of low testosterone at the end of each dosing interval."	( Population Pharmacokinetic Modeling and Simulations to Evaluate a Potential Dose Regimen of Testosterone Undecanoate in Hypogonadal Males. Bush, M; Curd, L; Hu, Y; Pastuszak, AW; Priestley, T; Vijayan, S; Xiang, Q, 2021)	0.84
" We conducted two-part studies to determine the optimal dosage and dosing cycle for efficient and stable induction of benign prostatic hyperplasia using testosterone undecanoate."	( Comparative application of testosterone undecanoate and/or testosterone propionate in induction of benign prostatic hyperplasia in Wistar rats. An, J; Kong, H, 2022)	1.22

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

Protein	Taxonomy	Measurement	Average (µ)	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Spike glycoprotein	Severe acute respiratory syndrome-related coronavirus	Potency	10.0000	0.0096	10.5250	35.4813	AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
virion membrane	Spike glycoprotein	Severe acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	44 (11.22)	18.7374
1990's	34 (8.67)	18.2507
2000's	125 (31.89)	29.6817
2010's	157 (40.05)	24.3611
2020's	32 (8.16)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	164 (37.70%)	5.53%
Reviews	28 (6.44%)	6.00%
Case Studies	13 (2.99%)	4.05%
Observational	23 (5.29%)	0.25%
Other	207 (47.59%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (223)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study [NCT01092858]	Phase 4	4 participants (Actual)	Interventional	2010-09-30	Terminated
A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair [NCT04345666]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2021-08-31	Withdrawn(stopped due to Unable to obtain funding to complete the study)
Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer. [NCT01122342]	Phase 1/Phase 2	30 participants (Anticipated)	Interventional	2006-12-31	Suspended(stopped due to Evaluating outcomes of current subjects pre further enrollment/dose reduction.)
Bipolar Androgen Therapy Plus Olaparib in Patient With Castration-Resistant Prostate Cancer [NCT03516812]	Phase 2	36 participants (Actual)	Interventional	2018-08-29	Active, not recruiting
Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients [NCT02990533]	Phase 1	80 participants (Actual)	Interventional	2016-09-30	Active, not recruiting
Subcutaneous Testosterone Therapy in Men Compared to Intramuscular Testosterone Therapy in Men [NCT03091348]	Phase 4	4 participants (Actual)	Interventional	2017-08-29	Completed
Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study. [NCT01291212]		104 participants (Actual)	Interventional	2011-01-31	Active, not recruiting
Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study [NCT04731376]	Phase 1	100 participants (Anticipated)	Interventional	2021-01-25	Recruiting
Androgen Treatment in Leydig Cell Proliferation [NCT01206270]	Phase 2/Phase 3	56 participants (Actual)	Interventional	2009-06-30	Completed
Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW [NCT03768258]		1,268 participants (Actual)	Observational	2008-03-31	Completed
Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD [NCT03674320]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2021-12-01	Withdrawn(stopped due to No Funding)
A Phase 1, Open-label, Randomized, Three-cohort, Two-period Crossover Study to Determine the Relative Bioavailability of Testosterone Following Application of Two Testosterone Transdermal Spray (TTS) Formulations Once Daily and Intrinsa® Patch Twice Weekl [NCT01096329]	Phase 1	16 participants (Actual)	Interventional	2010-02-28	Terminated
Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents [NCT02679274]	Early Phase 1	3 participants (Actual)	Interventional	2016-02-16	Terminated(stopped due to Lack of funding.)
Patient Satisfaction After Switching to Oral Testosterone Undecanoate in Men Currently on Testosterone Therapy [NCT04983940]	Phase 4	41 participants (Actual)	Interventional	2021-06-18	Completed
A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH) [NCT04134091]	Phase 2	56 participants (Actual)	Interventional	2019-08-27	Completed
Effects of Fast Acting Testosterone Nasal Spray on Anxiety [NCT02361190]		96 participants (Actual)	Interventional	2015-02-28	Completed
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 [NCT03792321]	Phase 4	55 participants (Actual)	Interventional	2014-01-10	Completed
A 150-Day, Prospective, Phase 4, Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Testosterone Nasal Gel (Natesto™) [NCT02937740]	Phase 4	117 participants (Actual)	Interventional	2016-10-31	Completed
Pubertal Replacement In Boys Study Pubertal Induction in Boys With Delayed Puberty: Comparison Between Testosterone Enanthate and Testosterone Undecanoate Treatment. [NCT05417035]		27 participants (Actual)	Interventional	2014-06-01	Completed
Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study [NCT05649605]		70 participants (Anticipated)	Interventional	2023-03-07	Recruiting
Phase 4 Study That Evaluates the Presence of Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism and Effects of Two Different Testosterone Replacement Regiments on These Parameters. [NCT02171390]	Phase 4	130 participants (Actual)	Interventional	2008-08-31	Completed
Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism [NCT04798469]	Phase 2	150 participants (Anticipated)	Interventional	2022-01-10	Recruiting
Transdermal Testosterone Nanoemulsion Effects Emergent Loss of Libido in Women: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT02445716]	Phase 2	70 participants (Anticipated)	Interventional	2015-10-31	Recruiting
A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception [NCT00403793]	Phase 2	350 participants (Actual)	Interventional	2003-10-31	Completed
Mechanisms of Hormonal Control of Spermatogenesis in Man [NCT02147964]	Phase 2	0 participants (Actual)	Interventional	2019-06-30	Withdrawn(stopped due to No funding was obtained for this study.)
Feasibility Study of Post-hospitalization Interventions to Improve Physical Function [NCT02203656]	Phase 1	113 participants (Actual)	Interventional	2013-10-31	Completed
A Randomized Phase I Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer [NCT01187485]	Phase 1	15 participants (Actual)	Interventional	2004-06-30	Completed
A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women [NCT01235754]	Phase 3	626 participants (Actual)	Interventional	2010-10-31	Completed
Effects of Testosterone on Myocardial Repolarization in Patients With Hypogonadism With/Without Chronic Heat Failure (NYHA Class I-II) [NCT03126656]	Phase 4	123 participants (Actual)	Interventional	2016-09-30	Completed
Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism [NCT05541172]		27 participants (Anticipated)	Observational	2022-03-01	Recruiting
Prospective, Randomized, Open-label and Comparative Study to Determine the Pharmacokinetic Parameters of Vaginal Rings That Contain DHEA, Testosterone, or the Combination of Both Androgens, in Comparison With Oral Administration of DHEA and Transdermal Ad [NCT03967964]	Phase 1	46 participants (Actual)	Interventional	2015-11-20	Completed
A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hyp [NCT01133548]	Phase 1	62 participants (Actual)	Interventional	2010-05-31	Completed
Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome [NCT01160341]	Phase 4	312 participants (Actual)	Interventional	2009-08-31	Completed
Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue [NCT03379012]	Phase 2	60 participants (Actual)	Interventional	2016-02-08	Completed
A 54 Week Treatment, Randomized, Multi Center, Double Blind, Placebo Controlled Study to Assess the Safety and Efficacy of NEBIDO 1000 mg (4 ml) in Elderly Men With Symptomatic Late Onset Hypogonadism (SLOH) [NCT00710827]	Phase 4	0 participants (Actual)	Interventional	2008-10-31	Withdrawn
Phase I Clinical Trial for Evaluation of Pharmacokinetics, Pharmacodynamics and Safety of Testosterone Gel 1% for Topical Use, After Administration of Three Different Doses (2.2 mg, 4.4 mg, 8.8 mg and Placebo) for 28 Consecutive Days in Post-menopausal Wo [NCT02667561]	Phase 1	0 participants (Actual)	Interventional	2017-07-31	Withdrawn(stopped due to Study has been cancelled and it has not been initiated.)
Effect of Dose Fractionation of Testosterone Cypionate on Hematocrit in Transgender Men With Erythrocytosis Secondary to Testosterone Use. [NCT05487794]		40 participants (Anticipated)	Interventional	2022-09-01	Recruiting
Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study [NCT03339635]	Phase 2	40 participants (Anticipated)	Interventional	2018-12-21	Active, not recruiting
The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans With Spinal Cord Injury [NCT06130449]	Early Phase 1	15 participants (Anticipated)	Interventional	2024-04-01	Not yet recruiting
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? [NCT05964920]	Phase 2/Phase 3	40 participants (Anticipated)	Interventional	2024-01-01	Not yet recruiting
A Randomized, Parallel, Double-dummy, Multi-center Phase III Study for Evaluation of Efficacy and Safety of Nasotestt Compared to Androgel Treating Hypogonadism in Male Research Participants. [NCT03281187]	Phase 3	228 participants (Anticipated)	Interventional	2018-07-16	Not yet recruiting
Prospective Biomarker Analysis of Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Undergoing Bipolar Androgen Therapy (BAT) [NCT04424654]	Phase 2	20 participants (Actual)	Interventional	2020-09-22	Completed
A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer [NCT06100705]	Phase 2	26 participants (Anticipated)	Interventional	2023-11-30	Not yet recruiting
A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer [NCT04363164]	Phase 2	150 participants (Anticipated)	Interventional	2020-08-19	Recruiting
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men [NCT03868059]	Phase 3	138 participants (Actual)	Interventional	2018-04-30	Completed
Phase IV: Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism [NCT01084369]	Phase 4	22 participants (Actual)	Interventional	2013-10-11	Terminated(stopped due to Withdrawal of sponsorship)
Testosterone Replacement Therapy in Chronic Spinal Cord Injury [NCT00266864]	Phase 2/Phase 3	31 participants (Actual)	Interventional	2003-08-31	Completed
Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men [NCT00799617]	Phase 3	790 participants (Actual)	Interventional	2009-11-30	Completed
Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels [NCT00613782]	Phase 2/Phase 3	88 participants (Actual)	Interventional	2009-01-31	Completed
52 Week RCT to Investigate the Effect of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese/Overweight Men With T2DM/Prediabetes and Hypogonadism and Subsequent 108 Week Open Label Phase to Investigate Effects on Cardiometabolic Para [NCT03851627]	Phase 4	32 participants (Anticipated)	Interventional	2022-01-25	Recruiting
Repeat Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Asymptomatic Patients With Metastatic Castration-Resistant Prostate Cancer: The APEX (Androgen and Polyamine Elimination Alternating With Xtandi) Trial [NCT06059118]	Phase 2	50 participants (Anticipated)	Interventional	2023-10-04	Recruiting
Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction. [NCT02803073]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2016-08-31	Withdrawn(stopped due to Subjects could not be recruited)
Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor [NCT05484167]	Phase 4	0 participants (Actual)	Interventional	2023-01-01	Withdrawn(stopped due to They study lost funding and decided to close the study down.)
Testosterone Supplementation in Men With MCI [NCT00539305]	Phase 3	22 participants (Actual)	Interventional	2009-07-31	Completed
Phase II Trial of Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer [NCT00853697]	Phase 2	6 participants (Actual)	Interventional	2009-03-31	Completed
Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use [NCT04895306]	Phase 2	40 participants (Anticipated)	Interventional	2022-04-30	Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men [NCT01017458]	Phase 1	68 participants (Actual)	Interventional	2007-06-30	Completed
An Open-Label Study to Evaluate the Safety of Testosterone Enanthate After Two Single-Dose Injections Via QuickShot® Testosterone by Intended Users and QuickShot™ Summative Usability Study [NCT02777242]	Phase 2	66 participants (Actual)	Interventional	2016-06-30	Completed
Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men [NCT00695110]	Phase 2	29 participants (Actual)	Interventional	2008-06-30	Completed
The Effect of Male Hormonal Contraceptive Regimens on Prostate Tissue In Normal Men [NCT00490555]	Phase 2/Phase 3	32 participants (Actual)	Interventional	2009-01-31	Completed
A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR) [NCT00816712]	Phase 1	28 participants (Actual)	Interventional	2008-01-31	Completed
Compromised Microcirculation in Women With Polycystic Ovary Syndrome [NCT00757185]	Early Phase 1	28 participants (Actual)	Interventional	2008-02-29	Completed
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [NCT00957801]	Phase 4	29 participants (Actual)	Interventional	2009-03-31	Completed
Effects of Early Testosterone Gel Administration on Physical Performance in the Critically Ill: a Randomised Double Blind Clinical Trial [NCT05825092]	Phase 2	600 participants (Anticipated)	Interventional	2023-07-21	Recruiting
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer [NCT06145399]	Early Phase 1	10 participants (Anticipated)	Interventional	2023-10-24	Recruiting
Nutrition and Anabolic Interventions in Squamous Cell Carcinoma [NCT00878995]	Phase 1	28 participants (Actual)	Interventional	2009-06-03	Completed
Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01) [NCT00848497]	Early Phase 1	3 participants (Actual)	Interventional	2007-11-30	Terminated(stopped due to Lack of volunteers who would consent to participate and lack of funding)
High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer [NCT03522064]	Phase 2	30 participants (Anticipated)	Interventional	2018-07-30	Recruiting
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men [NCT02081300]	Phase 3	315 participants (Actual)	Interventional	2014-02-28	Completed
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203 [NCT01386567]	Phase 2	48 participants (Actual)	Interventional	2011-07-31	Completed
Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men [NCT04134130]		33 participants (Actual)	Interventional	2019-09-16	Completed
The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men [NCT00700024]	Phase 4	60 participants (Anticipated)	Interventional	2008-04-30	Active, not recruiting
An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to Assess Bioequivalence of the 300 Mcg/Day Testosterone Reduced-size Patch (14 cm2) Relative to the 300 Mcg/Day Testosterone Reference Patch (28 cm2) [NCT00791856]	Phase 1	110 participants (Actual)	Interventional	2007-07-31	Completed
COMbination of Bipolar Androgen Therapy and Nivolumab in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03554317]	Phase 2	53 participants (Actual)	Interventional	2018-09-05	Completed
Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men Title Changed With New Protocol (12/14/09): Hormonal Regulation of HDL-C in Men [NCT00729859]	Phase 2	31 participants (Actual)	Interventional	2008-12-31	Completed
A Single-Center, Double-Masked, Randomized, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Testosterone 0.03% Ophthalmic Solution Compared to Vehicle for the Treatment of Meibomian Gland Dysfunction [NCT00755183]	Phase 2	60 participants (Actual)	Interventional	2008-07-31	Completed
Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer [NCT04049331]	Phase 2	240 participants (Anticipated)	Interventional	2021-03-22	Recruiting
A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism [NCT00812396]	Phase 1	30 participants (Actual)	Interventional	2007-11-30	Completed
A Two-Arm, Open-Label, Randomized, Multi-Center Pharmacokinetic and Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men [NCT00467870]	Phase 3	531 participants (Actual)	Interventional	2006-03-31	Completed
Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease [NCT00239590]	Phase 2	28 participants (Actual)	Interventional	2001-06-30	Completed
A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes [NCT03973840]	Phase 1	13 participants (Actual)	Interventional	2018-07-15	Completed
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections: A Phase IV, Prospective, Randomized, Non-Blinded, Multi-Institutional Study [NCT04439799]	Phase 4	81 participants (Actual)	Interventional	2020-08-07	Completed
Pilot Open Study of Testosterone Replacement in Non-alcoholic Steatohepatitis [NCT01919294]	Phase 2	3 participants (Actual)	Interventional	2013-07-31	Completed
Androgen Regulation of Priapism in Sickle Cell Disease [NCT01940718]	Early Phase 1	0 participants (Actual)	Interventional	2014-03-31	Withdrawn(stopped due to Funding could not be secured)
Clinical Trial of Androgen Effects on the Reproductive Neuroendocrine Axis [NCT04321551]	Phase 4	40 participants (Anticipated)	Interventional	2023-07-01	Not yet recruiting
Double-Blind, Placebo Controlled Randomized Study of Co-Administering Testosterone With PDE5 Inhibitors in Patients Non-Responders to PDE5 Inhibitors Alone [NCT00244023]	Phase 3	173 participants (Actual)	Interventional	2005-10-31	Completed
A Pilot Study in Healthy Male Volunteers to Evaluate a Skeletal-Muscle Microbiopsy Technique for Suitability of Use With Dynamic Proteomic Measurement [NCT01962454]	Phase 1	20 participants (Actual)	Interventional	2014-05-05	Completed
A Preliminary Trial of Testosterone Replacement for Fatigue in Male Hypogonadic Patients With Advanced Cancer. [NCT00965341]	Phase 3	53 participants (Actual)	Interventional	2009-09-30	Completed
Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women [NCT02215434]	Phase 2	60 participants (Actual)	Interventional	2009-09-30	Completed
A Randomized Double-blind Placebo-controlled Pilot Trial on the Effects of Testosterone Undecanoate Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolic Profile in Transmen [NCT04545450]	Phase 3	16 participants (Actual)	Interventional	2008-11-04	Completed
Testosterone and Alendronate in Hypogonadal Men [NCT01460654]	Phase 2	44 participants (Actual)	Interventional	2011-10-31	Terminated
Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience [NCT01601327]	Phase 4	119 participants (Actual)	Interventional	2008-01-31	Completed
Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia [NCT00838838]		26 participants (Actual)	Observational	2005-09-30	Completed
Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption: Evaluation of Newly Developed Markers [NCT04166786]	Phase 1	4 participants (Actual)	Interventional	2019-05-06	Completed
Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation [NCT00675714]	Phase 2/Phase 3	1,126 participants (Actual)	Interventional	2004-01-31	Terminated(stopped due to At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.)
The Effects of Cyclic Testosterone Administration on Muscle Function in Older Individuals [NCT00957528]	Phase 1	26 participants (Actual)	Interventional	2006-01-31	Completed
The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men [NCT01417364]	Phase 4	0 participants (Actual)	Interventional	2016-01-31	Withdrawn(stopped due to Unable to identify any qualifying subjects willing to enroll into this study.)
The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1) [NCT00161486]	Phase 1	13 participants (Actual)	Interventional	2004-07-31	Completed
The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa [NCT00853502]	Phase 2	0 participants (Actual)	Interventional	2008-12-31	Withdrawn(stopped due to No recruitment)
A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men [NCT00696748]	Phase 3	250 participants (Anticipated)	Interventional	2005-10-31	Recruiting
Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application [NCT00705796]	Phase 1	0 participants (Actual)	Interventional		Withdrawn(stopped due to financial constraints)
Locomotor Training With Testosterone to Promote Bone and Muscle Health [NCT04460872]	Phase 2	21 participants (Anticipated)	Interventional	2021-01-31	Recruiting
Salivary Testosterone in Men: Diurnal Variation and Post-prandial Responses [NCT04326673]		40 participants (Actual)	Observational	2020-10-30	Active, not recruiting
Study of Testosterone and rHGH in FSHD (STARFISH): A Proof-of-Concept Study [NCT03123913]	Phase 1	20 participants (Actual)	Interventional	2017-12-18	Completed
Exercise Training and Testosterone Replacement in Heart Failure Patients [NCT01852994]	Phase 4	39 participants (Actual)	Interventional	2009-07-31	Completed
The Effects of Natesto For Treatment Of Hypogonadism On Maintenance Of Spermatogensis. [NCT04717362]	Early Phase 1	40 participants (Anticipated)	Interventional	2024-03-01	Not yet recruiting
An Open-Label, Randomized, Balanced, Single-Dose, Two Treatment, Four Period, Two Sequence Replicate Design, Bioequivalence Study Of Testosterone Topical Gel, 1.62% Metered Pump, Manufactured By Amneal Pharmaceuticals LLC With AndroGel (Testosterone Gel) [NCT02110368]	Phase 3	32 participants (Actual)	Interventional	2014-03-31	Completed
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV. [NCT00555087]	Phase 4	50 participants (Anticipated)	Interventional	2007-05-31	Recruiting
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women [NCT01724658]	Phase 2	70 participants (Actual)	Interventional	2012-06-30	Completed
Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men [NCT00452322]	Phase 2	60 participants	Interventional	1997-04-30	Completed
Phase IV Study of The Therapy of Long-acting Testosterone Undecanoate,1000mg in 4 ml Oily Solution for i.m.Injection(Nebido) as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction [NCT00421460]	Phase 4	30 participants (Actual)	Interventional	2007-01-31	Completed
Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome [NCT00487734]	Phase 4	19 participants (Actual)	Interventional	2007-08-31	Completed
Pilot Study: Evaluating the Effect of 300 Micrograms Testosterone Patches in Addition to Hormone Replacement Therapy on Arterial Compliance, Insulin Resistance and Sexual Desire. [NCT01208038]	Phase 4	22 participants (Actual)	Interventional	2011-03-31	Completed
The Role of 5-Alpha Reductase in Mediating Testosterone Actions [NCT00070733]	Phase 3	184 participants	Interventional	2003-08-31	Recruiting
Testosterone and Physical Function in HIV Associate Weight Loss [NCT00260143]	Phase 2	61 participants (Actual)	Interventional	2003-05-31	Completed
An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components [NCT00400335]	Phase 1	60 participants (Actual)	Interventional	2006-10-31	Completed
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency [NCT00434824]	Phase 2	322 participants (Actual)	Interventional	2001-11-30	Completed
The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly [NCT00117000]	Phase 3	200 participants	Interventional	2003-07-31	Active, not recruiting
[NCT00119483]		200 participants	Interventional	2005-09-30	Completed
The Role of 5-alpha Reductase in Mediating Testosterone Actions [NCT00493987]	Phase 4	184 participants (Anticipated)	Interventional	2002-11-30	Completed
Muscle Strength and -Mass After Bariatric Surgery - a Possible Effect of Testosterone Replacement Therapy? Randomized, Placebo-controlled and Double-blinded Study [NCT03721497]	Phase 4	50 participants (Anticipated)	Interventional	2020-12-17	Recruiting
The Effect of Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina [NCT00131183]	Phase 4	15 participants (Actual)	Interventional	2005-09-30	Completed
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women [NCT00141570]	Phase 2	350 participants	Interventional	2004-06-30	Completed
Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men) [NCT00161304]	Phase 2/Phase 3	44 participants (Actual)	Interventional	2003-04-30	Completed
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women [NCT00141557]	Phase 2	133 participants (Actual)	Interventional	2004-07-31	Terminated(stopped due to Lack of enrollment)
Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men. [NCT00911586]	Phase 2	15 participants (Actual)	Interventional	2009-07-31	Completed
Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men [NCT00924612]	Phase 2	16 participants (Actual)	Interventional	2009-07-31	Completed
Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics [NCT00220298]	Phase 3	96 participants (Actual)	Interventional	2003-02-28	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two Period Cross Over Trial to Validate Patient-Reported Outcome Measures for Use in Men With Late Onset Hypogonadism [NCT00254553]	Phase 2	150 participants (Actual)	Interventional	2005-07-31	Terminated(stopped due to Recruitment issues)
Regulation of Cortisol Metabolism and Fat Patterning [NCT00694733]		140 participants (Actual)	Interventional	2005-05-31	Active, not recruiting
Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2) [NCT01327495]	Phase 2/Phase 3	62 participants (Actual)	Interventional	2011-10-31	Completed
A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients [NCT01516554]	Phase 2	3 participants (Actual)	Interventional	2012-02-29	Terminated(stopped due to Poor recruitment)
Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus (HIV)-Associated Wasting. [NCT00001079]	Phase 2	80 participants	Interventional		Completed
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women [NCT00141544]	Phase 2	28 participants (Actual)	Interventional	2004-07-31	Terminated(stopped due to Lack of enrollment)
Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme [NCT00847314]		30 participants (Actual)	Observational	2007-06-30	Completed
A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease [NCT00392912]		10 participants (Actual)	Interventional	2007-04-30	Completed
A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride [NCT00398580]	Phase 2	43 participants (Actual)	Interventional	2006-10-31	Completed
Oral Androgens in Man-4: Gonadotropin Suppression Medicated by Oral Testosterone Enanthate in Oil Plus Dutasteride (Short Title: Oral T-4) [NCT00399165]	Phase 1/Phase 2	20 participants (Actual)	Interventional	2006-11-30	Completed
A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State and Compared to Testosterone Undecanoate in Adult Men W [NCT02966652]	Phase 1	25 participants (Actual)	Interventional	2016-11-03	Completed
Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals) [NCT00146146]	Phase 3	15 participants (Actual)	Interventional	2005-05-31	Completed
A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women [NCT00160342]	Phase 2	1,251 participants (Anticipated)	Interventional	2005-06-30	Completed
Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial [NCT00405353]	Phase 1/Phase 2	10 participants (Actual)	Interventional	2002-04-30	Completed
5-Alpha Reductase and Anabolic Effects of Testosterone [NCT00475501]	Phase 2	60 participants (Actual)	Interventional	2007-01-31	Completed
Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism [NCT00663793]	Phase 1	16 participants (Actual)	Interventional	2008-10-31	Completed
A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors [NCT00698035]	Phase 2	76 participants (Actual)	Interventional	2007-03-31	Completed
A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer [NCT02286921]	Phase 2	222 participants (Actual)	Interventional	2015-01-31	Completed
Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical Disabilities [NCT02990507]		40 participants (Actual)	Interventional	2017-02-10	Completed
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment [NCT02408445]	Phase 4	20 participants (Actual)	Interventional	2015-05-08	Completed
Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury [NCT01652040]	Phase 2/Phase 3	26 participants (Actual)	Interventional	2012-07-02	Completed
A Phase II Study of Bipolar Androgen-based Therapy for Men With Androgen Ablation NaÃ-ve Recurrent Prostate Cancer [NCT01750398]	Phase 2	33 participants (Actual)	Interventional	2013-01-31	Completed
An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women With Low Testosterone and Hypoactive Sexual Desire Disorder [NCT06082817]	Phase 2	30 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
SPECTRA: SupraPhysiological Androgen to Enhance Chemotherapy TReatment Activity [NCT06039371]	Phase 2	46 participants (Anticipated)	Interventional	2024-01-01	Not yet recruiting
International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido) [NCT00410306]		1,493 participants (Actual)	Observational	2006-10-31	Completed
Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion. [NCT00230984]	Phase 3	200 participants	Interventional	2003-04-30	Completed
The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes: OTEST [NCT01510847]	Phase 4	19 participants (Actual)	Interventional	2011-10-31	Terminated(stopped due to Unable to reach the target recruitment within timeline)
A Randomized Double Blind Control Trial of Transdermal Testosterone Supplementation vs Placebo on Follicular Development and Atresia, Oocyte and Embryo Quality Among Women With Diminished Ovarian Reserve Undergoing in Vitro Fertilization [NCT01662466]	Phase 1/Phase 2	180 participants (Anticipated)	Interventional	2012-07-01	Recruiting
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men [NCT01252745]	Phase 2	22 participants (Actual)	Interventional	2010-08-31	Completed
Satisfaction and Quality of Life of Men and Spouses of Hypogonadal Men Treated With Injectable Testosterone Undecanoate [NCT01758029]		80 participants (Anticipated)	Observational	2013-01-31	Not yet recruiting
A Randomized and Double-blind Study to Evaluate the Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects [NCT01813201]	Phase 4	14 participants (Actual)	Interventional	2011-03-31	Completed
Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men [NCT01143818]		1,053 participants (Actual)	Observational	2007-12-31	Completed
A Phase II Study Assessing the Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer [NCT05081193]	Phase 2	30 participants (Anticipated)	Interventional	2022-03-07	Recruiting
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY [NCT03325647]	Phase 4	72 participants (Actual)	Interventional	2017-11-06	Completed
Collaborative Study: Testosterone Antidepressant Augmentation in Women [NCT01783574]		101 participants (Actual)	Interventional	2013-08-31	Completed
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men [NCT01686828]	Phase 1/Phase 2	53 participants (Actual)	Interventional	2013-06-30	Completed
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial [NCT05722301]	Phase 3	0 participants (Actual)	Interventional	2019-11-01	Withdrawn(stopped due to Study was never initiated.)
A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days [NCT01446042]	Phase 3	306 participants (Actual)	Interventional	2011-09-30	Completed
A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men [NCT01386606]	Phase 2	60 participants (Actual)	Interventional	2011-06-30	Completed
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical [NCT04342247]		30 participants (Actual)	Observational	2019-01-01	Completed
Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men. [NCT03242590]	Phase 3	95 participants (Actual)	Interventional	2016-12-31	Completed
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer [NCT01084759]		16 participants (Actual)	Interventional	2010-03-31	Completed
A Pilot Study of Subcutaneous vs. Intramuscular Testosterone for Gender Affirming Therapy [NCT02229617]	Phase 1/Phase 2	14 participants (Actual)	Interventional	2015-07-31	Completed
An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels [NCT01364623]	Phase 1	24 participants (Actual)	Interventional	2011-09-30	Completed
IGF-1 and Bone Loss in Women Anorexia Nervosa [NCT00089843]	Phase 2/Phase 3	77 participants (Actual)	Interventional	2003-06-30	Completed
A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II) [NCT04120363]	Phase 4	34 participants (Actual)	Interventional	2019-09-23	Completed
Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatmen [NCT01454011]	Phase 4	140 participants (Actual)	Interventional	2008-09-30	Completed
CYP19A1 Gene and Pharmacogenetics of Response [NCT01378299]	Phase 1	105 participants (Actual)	Interventional	2011-10-01	Completed
Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) [NCT04558866]	Phase 2	51 participants (Actual)	Interventional	2021-04-30	Active, not recruiting
Hormones and Decision Making [NCT04865562]	Phase 4	30 participants (Actual)	Interventional	2015-03-01	Completed
Will Testosterone and Growth Hormone Improve Bone Structure? [NCT00080483]	Phase 2	35 participants (Actual)	Interventional	2004-03-31	Completed
Testosterone Supplementation and Exercise in Elderly Men [NCT00112151]	Phase 2	167 participants (Actual)	Interventional	2005-01-31	Completed
A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism [NCT02504541]	Phase 3	133 participants (Actual)	Interventional	2015-07-31	Completed
The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery [NCT01595581]	Phase 3	14 participants (Actual)	Interventional	2012-04-30	Completed
A Phase 2 Study of the Effect of Meals With Various Amounts of Fat Given Immediately After Dosing on the Pharmacokinetics of an Oral Testosterone Undecanoate [NCT02921386]	Phase 2	18 participants (Actual)	Interventional	2016-10-31	Completed
An Open-Label, Nine-Month Randomized Controlled Study of Testosterone (Testopel) Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease [NCT01578473]	Phase 1	75 participants (Actual)	Interventional	2013-05-23	Completed
An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Administration With Marketed Testosterone Products [NCT04456296]	Phase 4	676 participants (Actual)	Interventional	2020-06-30	Completed
Effect of Transgender Therapy on Hormone Receptors, Adipogenesis, Myogenesis and Inflammation [NCT04551144]		4 participants (Actual)	Observational	2020-10-06	Active, not recruiting
Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers. [NCT04757532]	Phase 1	9 participants (Actual)	Interventional	2020-12-03	Completed
Testosterone and Long Pulse Width Stimulation for Denervated Muscles After Spinal Cord Injury [NCT03345576]	Phase 2	12 participants (Actual)	Interventional	2018-07-01	Completed
Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters [NCT03203681]	Phase 4	60 participants (Actual)	Interventional	2017-10-27	Completed
Randomized Control Trial of Long Acting Subcutaneous Testosterone Pellets for Hypogonadism: Testopel ® vs. Generic Testosterone Pellets. [NCT04523480]	Phase 3	75 participants (Actual)	Interventional	2020-03-12	Completed
Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury [NCT03576001]	Phase 2	88 participants (Anticipated)	Interventional	2019-08-23	Recruiting
Phase IIa, Pilot, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men [NCT02697188]	Phase 2	12 participants (Actual)	Interventional	2007-11-30	Completed
Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men [NCT02670343]	Phase 1/Phase 2	8 participants (Actual)	Interventional	2016-01-31	Completed
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial [NCT02734238]	Phase 4	53 participants (Actual)	Interventional	2016-04-30	Completed
Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters. [NCT04336891]		81 participants (Actual)	Observational	2019-03-20	Completed
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men. [NCT03242408]	Phase 3	100 participants (Actual)	Interventional	2017-01-31	Completed
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis [NCT03910738]	Phase 2	40 participants (Anticipated)	Interventional	2019-10-29	Recruiting
Pilot Randomized, Controlled Trial of Testosterone Therapy in Chronic Critically Ill Patients and Its Potential Effects on Weaning From Mechanical Ventilation and Intensive Care Unit-acquired Weakness [NCT03038919]	Phase 2/Phase 3	30 participants (Anticipated)	Interventional	2016-10-31	Recruiting
A Randomized, Two Center, Double-Blind Trial to Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Healthy Men [NCT02432261]	Phase 1	44 participants (Actual)	Interventional	2015-04-30	Completed
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence [NCT03116087]		60 participants (Actual)	Interventional	2007-03-01	Completed
An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects [NCT02233751]	Phase 1	12 participants (Actual)	Interventional	2014-09-30	Completed
A Pilot Study To Evaluate The Effect of Testosterone Enanthate On Structural and Functional Characteristics of Pelvic Floor Muscles In Postmenopausal Women With Urinary Incontinence [NCT04026880]	Phase 3	0 participants (Actual)	Interventional	2021-01-01	Withdrawn(stopped due to Lack of funds)
Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI [NCT02248701]	Phase 2	33 participants (Actual)	Interventional	2017-04-27	Terminated(stopped due to Enrollment difficulties)
A Pilot Study of Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer [NCT02995330]	Phase 1	3 participants (Actual)	Interventional	2017-02-09	Terminated(stopped due to lack of accrual)
Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT01699178]	Phase 3	182 participants (Actual)	Interventional	2012-08-31	Completed
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency [NCT03716739]	Phase 2	142 participants (Anticipated)	Interventional	2019-03-19	Recruiting
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women [NCT03314298]	Phase 1	11 participants (Actual)	Interventional	2017-08-14	Completed
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel [NCT01893281]	Phase 4	78 participants (Actual)	Interventional	2013-07-31	Completed
Optimizing Protein Intake in Older Americans With Mobility Limitations [NCT01275365]	Phase 3	92 participants (Actual)	Interventional	2011-05-31	Completed
Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men [NCT01765179]	Phase 3	144 participants (Actual)	Interventional	2013-01-31	Completed
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT01403116]	Phase 3	325 participants (Actual)	Interventional	2011-07-31	Completed
A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men [NCT01816295]	Phase 3	715 participants (Actual)	Interventional	2013-05-31	Completed
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men [NCT02722278]	Phase 3	222 participants (Actual)	Interventional	2016-03-31	Completed
A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence [NCT06111209]	Phase 2	30 participants (Anticipated)	Interventional	2024-05-31	Not yet recruiting
Clinical Effect of Follicular Preparation With Testosterone in Poor Ovarian Response: a Randomized Controlled Clinical Trial (TESTOPRIM) [NCT03378713]	Phase 3	63 participants (Actual)	Interventional	2017-08-07	Completed
Hormonal Mechanisms of Sleep Restriction [NCT02256865]	Early Phase 1	40 participants (Actual)	Interventional	2014-10-31	Completed
Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism [NCT00350701]	Phase 4	49 participants (Actual)	Interventional	2006-07-31	Completed
A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy (BAT) Followed by Enzalutamide or Abiraterone Post-BAT in Men With Prostate Cancer Progressing on Combined Androgen Ablative Therapies [NCT02090114]	Phase 2	112 participants (Actual)	Interventional	2014-08-25	Completed
Cardiovascular Consequences of Hypogonadism in Men [NCT02758431]		379 participants (Anticipated)	Interventional	2016-07-01	Active, not recruiting
Randomized, Double-blind, Parallel, Placebo-controlled, Clinical Trial to Assess the Efficacy of Testosterone, Metformin, or Both, for the Treatment of Obesity-induced Male Hypogonadism [NCT02514629]	Phase 3	107 participants (Actual)	Interventional	2013-07-04	Completed
3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males [NCT01887418]	Phase 1/Phase 2	39 participants (Actual)	Interventional	2013-09-30	Completed
A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism [NCT02159469]	Phase 3	150 participants (Actual)	Interventional	2014-07-31	Completed
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome [NCT04327934]	Early Phase 1	22 participants (Actual)	Interventional	2017-12-01	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00080483 (1) [back to overview]	MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.
NCT00089843 (2) [back to overview]	Markers of Bone Metabolism
NCT00089843 (2) [back to overview]	Bone Mineral Density
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)
NCT00112151 (6) [back to overview]	Lower Body Muscle Strength (1-RM, kg)
NCT00112151 (6) [back to overview]	Fat Mass (kg)
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 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 With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C
NCT00467870 (35) [back to overview]	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]	Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2
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]	Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Serum Total Testosterone 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 B
NCT00467870 (35) [back to overview]	Serum Total Testosterone Maximum Concentration in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2
NCT00467870 (35) [back to overview]	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 4th Injection Interval in Part C
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]	Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2
NCT00467870 (35) [back to overview]	Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C
NCT00467870 (35) [back to overview]	Percentage of Participants 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]	Grip Strength kg
NCT00475501 (11) [back to overview]	Geriatric Depression Scale
NCT00475501 (11) [back to overview]	Dietary Protein Intake
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]	Benton Judgment of Line Orientation Test
NCT00475501 (11) [back to overview]	Trail-Making Test, Part A
NCT00475501 (11) [back to overview]	Transrectal Ultrasound Sizing of Prostate
NCT00475501 (11) [back to overview]	Lumbar Spine L2-L4 Bone Mineral Density
NCT00475501 (11) [back to overview]	Life Satisfaction
NCT00475501 (11) [back to overview]	Hematocrit
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]	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]	Serum Estradiol (E2)
NCT00698035 (7) [back to overview]	Matched E2 by Commercial and Research (RIA) Analyses
NCT00698035 (7) [back to overview]	Sexual Quality of Life
NCT00698035 (7) [back to overview]	Sexual Satisfaction
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]	Estradiol Concentration
NCT00729859 (10) [back to overview]	Endothelial Progenitor Cells
NCT00729859 (10) [back to overview]	Follicle Stimulating Hormone (FSH)
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
NCT00729859 (10) [back to overview]	Homeostasis Model of Insulin Resistance (HOMA-IR)
NCT00755183 (2) [back to overview]	Meibomian Gland Secretion Appearance at Visit 4 (Day 168)
NCT00755183 (2) [back to overview]	Ocular Discomfort Score at Visit 4
NCT00799617 (37) [back to overview]	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 ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
NCT00848497 (4) [back to overview]	Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
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.
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 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]	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 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.
NCT00878995 (47) [back to overview]	Concentration of Cytokine Interleukin 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 10 (IL-10) 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]	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 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]	Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
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]	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]	Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.
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
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 Body Mass Index (BMI)
NCT01143818 (4) [back to overview]	Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score
NCT01143818 (4) [back to overview]	Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score
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
NCT01208038 (4) [back to overview]	Insulin Resistance - HOMA-IR
NCT01252745 (3) [back to overview]	Cavg of Serum Testosterone
NCT01252745 (3) [back to overview]	Cmax of Serum Testosterone
NCT01252745 (3) [back to overview]	AUC0-t of Serum Testosterone
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
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 50-meter Loaded Walking Test
NCT01275365 (10) [back to overview]	Change of 6-minute Walking Distance
NCT01275365 (10) [back to overview]	Change of Stair Climbing Tests
NCT01275365 (10) [back to overview]	Change of Psychological Well Being Index (PGWBI)
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 Maximal Voluntary Strength
NCT01327495 (14) [back to overview]	Progesterone
NCT01327495 (14) [back to overview]	17-OHPreg
NCT01327495 (14) [back to overview]	Dihydrotestosterone (DHT)
NCT01327495 (14) [back to overview]	Androsterone
NCT01327495 (14) [back to overview]	International Prostate Symptom Score (IPSS)
NCT01327495 (14) [back to overview]	Serum Testosterone
NCT01327495 (14) [back to overview]	Prostate Volume
NCT01327495 (14) [back to overview]	Prostate Tissue Testosterone Concentrations After Treatment
NCT01327495 (14) [back to overview]	Prostate Tissue DHT Concentrations After Treatment
NCT01327495 (14) [back to overview]	DHEA
NCT01327495 (14) [back to overview]	17-OHP
NCT01327495 (14) [back to overview]	Androstenedione
NCT01327495 (14) [back to overview]	Prostate Specific Antigen
NCT01327495 (14) [back to overview]	Pregnenolone
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 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
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 Bone Turnover Markers According the Presence of Diabetes Mellitus
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 Turnover Markers According to the rs700518 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 re1062033 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
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]	Morning Testosterone Correlated With Serial Testosterone.
NCT01386606 (7) [back to overview]	Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
NCT01386606 (7) [back to overview]	Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
NCT01386606 (7) [back to overview]	Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
NCT01386606 (7) [back to overview]	24 Hour Average and Maximum Testosterone Concentration
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]	Changes in Lean Mass
NCT01595581 (3) [back to overview]	KOOS Scores
NCT01595581 (3) [back to overview]	Strength
NCT01652040 (2) [back to overview]	Body Composition
NCT01652040 (2) [back to overview]	Metabolic Profile
NCT01686828 (3) [back to overview]	Changes in Adipose Tissue Gene Expression
NCT01686828 (3) [back to overview]	Insulin Sensitivity Quantified by Matsuda Index
NCT01686828 (3) [back to overview]	Changes in Body Composition
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in T Cholesterol
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in LDL
NCT01699178 (6) [back to overview]	Absolute Change From Baseline in Prostate Volume
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
NCT01750398 (7) [back to overview]	Patients With PSA <4 ng/mL at the End of the Study
NCT01750398 (7) [back to overview]	Change in C-telopeptides
NCT01750398 (7) [back to overview]	Radiographic or Clinical Progression
NCT01750398 (7) [back to overview]	Quality of Life Survey
NCT01750398 (7) [back to overview]	Complete PSA Response
NCT01750398 (7) [back to overview]	Change in Weight
NCT01750398 (7) [back to overview]	Change in Waist Circumference
NCT01765179 (2) [back to overview]	Percentage of Treated Patients With 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]	Sexual Dysfunction
NCT01783574 (3) [back to overview]	Fatigue
NCT01783574 (3) [back to overview]	Depressive Symptom Severity
NCT01816295 (5) [back to overview]	Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
NCT01816295 (5) [back to overview]	Change From Baseline 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)
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]	Change From Baseline in Serum Testosterone Levels
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]	Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level
NCT01893281 (4) [back to overview]	Percentage of Participants Achieving Normal Serum Testosterone Levels
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]	Half-life (t 1/2)(hr)
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]	Clearance CL/F (L/hr)
NCT02233751 (7) [back to overview]	Area Under the Concentration-time Curve From Time Zero to Time t
NCT02233751 (7) [back to overview]	Area Under the Concentration-time Curve From Time Zero to Infinity
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]	Pain Severity as Assessed by the Brief Pain Inventory
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]	Radiographic Progression
NCT02286921 (14) [back to overview]	Time to Prostate-Specific Antigen Progression
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 the Positive 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 FACIT Fatigue Scale
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 Total Motor Standard Score on the Peabody Developmental Motor Scales 2
NCT02408445 (10) [back to overview]	Change in Raw Score on the Alberta Infant Motor Scale
NCT02408445 (10) [back to overview]	Change in Penile Length
NCT02408445 (10) [back to overview]	Change in Fat Free Mass
NCT02408445 (10) [back to overview]	Change in Body Fat Percent Z-score
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]	Serum Follicle Stimulating Hormone (FSH)
NCT02408445 (10) [back to overview]	Serum Anti-Mullerian Hormone (AMH)
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 Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7
NCT02722278 (2) [back to overview]	Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8
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]	Change in Hypogonadism Symptoms
NCT02937740 (2) [back to overview]	Patient Satisfaction - Change From Baseline
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 Level of Free Testosterone in the Blood
NCT03123913 (8) [back to overview]	Number of Participants Who Experienced an AE
NCT03123913 (8) [back to overview]	Mean Change in Total Lean Body Mass
NCT03123913 (8) [back to overview]	Mean Change in Level of FSH in the Blood
NCT03123913 (8) [back to overview]	Mean Change in Level of IGF-1 in the Blood
NCT03203681 (6) [back to overview]	Incidence of Adverse Events
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]	Number of Participants With an Increase in SF-36 QOL Scores From Baseline
NCT03203681 (6) [back to overview]	Change in Gonadotropin Levels From Baseline to 27 Weeks
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 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]	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 is SBP Dip
NCT03868059 (26) [back to overview]	Change in Patient Reported Sexual Distress
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
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 in Patient Reported Sexual Desire
NCT03868059 (26) [back to overview]	Change in ABPM-measured Average 24-hour Pulse Rate (PR)
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]	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]	Relative Change in Whole Body Fat Mass
NCT04134091 (13) [back to overview]	Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
NCT04134091 (13) [back to overview]	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]	Mean Changes in Serum Lipid Profile Parameters 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 Hematocrit (Hct) Levels.
NCT04523480 (4) [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
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

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

[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

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

[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

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

[back to top]

Fat Free Mass (kg)

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

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

[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

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

[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

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

[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

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

[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

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

[back to top]

Fat Mass (kg)

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

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

[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)

Intervention	myocardial perfusion index (Mean)
Testosterone	1.83
Placebo	1.52

[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)

Intervention	Augmentation index (Mean)
Testosterone	76.5
Placebo	79.4

[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

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

[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

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

[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

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

[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

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

[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

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

[back to top]

Whole Brain Atrophy Rate

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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[back to top]

Change in Weight From Baseline to Week 24 in Part C

(NCT00467870)
Timeframe: Baseline, Week 24

Intervention	kg (Mean)
C-TU 750 mg	0.06

[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

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

[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

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

[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

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

[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

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

[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

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

[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

Intervention	days (Mean)
C-TU 750 mg	50.2

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

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

[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

Intervention	days (Mean)
C-TU 750 mg	60.6

[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

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

[back to top]

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

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

[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

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

[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

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

[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

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

[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

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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

,,,

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

[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 1	42.6	3.6	4.044	4.071	5.22
Arm 2	41.2	0.611	0.557	0.63	-1.175
Arm 3	42.0	4.593	4.331	3.38	4.173
Arm 4	40.3	-0.06	0.514	-0.155	-0.192

[back to top]

Prostate-specific Antigen (PSA)

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

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

[back to top]

Testosterone Concentration

(NCT00490555)
Timeframe: 10 weeks

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

[back to top]

Dihydrotestosterone (DHT) Concentration

(NCT00490555)
Timeframe: 10 weeks

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

[back to top]

Dehydroepiandrosterone (DHEA)

(NCT00490555)
Timeframe: 10 weeks

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

[back to top]

Androstenedione (AED)

(NCT00490555)
Timeframe: 10 weeks

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

[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

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

[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

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

[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

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

[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

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

[back to top]

Area Under the Curve-E2

(NCT00663793)
Timeframe: 14 Days

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

[back to top]

Area Under the Curve-Serum T

(NCT00663793)
Timeframe: 14 days

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

[back to top]

Area Under the Curve-serum DHT

(NCT00663793)
Timeframe: 14-days

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

[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

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

[back to top]

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

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

[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 food	AUC (12-24) (PM dose) with food
Treatment Period 1	19009	9179	9830
Treatment Period 2	15693	7881	7812
Treatment Period 4	12980	6601	2894

[back to top]

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

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

[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

Intervention	participants (Number)
Estring	0
Testosterone Cream	4

[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

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

[back to top]

Serum Estradiol (E2)

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

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

[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

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

[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

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

[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

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

[back to top]

Total Testosterone Levels

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

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

[back to top]

Luteinizing Hormone Concentration (LH)

(NCT00729859)
Timeframe: Baseline, Day 28

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

[back to top]

Fasting Lipid Levels

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

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

[back to top]

Fasting Serum Insulin

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

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

[back to top]

Estradiol Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

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

[back to top]

Endothelial Progenitor Cells

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

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

[back to top]

Follicle Stimulating Hormone (FSH)

(NCT00729859)
Timeframe: Baseline, 28 days

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

[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

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

[back to top]

Sex Hormone Binding Globulin (SHBG)

(NCT00729859)
Timeframe: Baseline, Day 28

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

[back to top]

Testosterone Concentration

(NCT00729859)
Timeframe: Baseline, Day 28

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

[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

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

[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

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

[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

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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)

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

[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

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

[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

Intervention	units 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

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

[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

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

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	13.35
Arm II: Standard of Care Therapy + Testosterone	94.52

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	4.36
Arm II: Standard of Care Therapy + Testosterone	28.36

[back to top]

1-year Survival

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

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

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	11.45
Arm II: Standard of Care Therapy + Testosterone	12.34

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.11
Arm II: Standard of Care Therapy + Testosterone	1.98

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	8.89
Arm II: Standard of Care Therapy + Testosterone	23.09

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	11.04
Arm II: Standard of Care Therapy + Testosterone	43.99

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	9.97
Arm II: Standard of Care Therapy + Testosterone	18.16

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	6.57
Arm II: Standard of Care Therapy + Testosterone	21.61

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.94
Arm II: Standard of Care Therapy + Testosterone	44.04

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	12.84
Arm II: Standard of Care Therapy + Testosterone	82.46

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	14.57
Arm II: Standard of Care Therapy + Testosterone	16.62

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	33.52
Arm II: Standard of Care Therapy + Testosterone	12.22

[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

Intervention	kilo-calories per day (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	1338.10
Arm II: Standard of Care Therapy + Testosterone	1260.98

[back to top]

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

Intervention	kilo-calories per day (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	1329.20
Arm II: Standard of Care Therapy + Testosterone	1310.81

[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

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

[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

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

[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

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

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	11.87
Arm II: Standard of Care Therapy + Testosterone	13.88

[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

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

[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

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

[back to top]

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

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

[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

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

[back to top]

Mood Measured by Profile of Mood States at Baseline

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

[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

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

[back to top]

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

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

[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 Testosterone	73.55
Arm II: Standard of Care Therapy + Testosterone	74.74

[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

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

[back to top]

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

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

[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

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

[back to top]

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

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

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	2.50
Arm II: Standard of Care Therapy + Testosterone	20.50

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.02
Arm II: Standard of Care Therapy + Testosterone	2.39

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.62
Arm II: Standard of Care Therapy + Testosterone	3.92

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	10.48
Arm II: Standard of Care Therapy + Testosterone	2.35

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	4.30
Arm II: Standard of Care Therapy + Testosterone	3.13

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.82
Arm II: Standard of Care Therapy + Testosterone	17.95

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.13
Arm II: Standard of Care Therapy + Testosterone	12.62

[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

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

[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

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

[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

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

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	64.15
Arm II: Standard of Care Therapy + Testosterone	191.17

[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

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

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	3.02
Arm II: Standard of Care Therapy + Testosterone	14.56

[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

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

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	21.62
Arm II: Standard of Care Therapy + Testosterone	15.71

[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

Intervention	picogram/milliliter (Mean)
Arm I: Standard of Care Therapy + Placebo Testosterone	2.13
Arm II: Standard of Care Therapy + Testosterone	1.71

[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

Intervention	ng/dL (Least Squares Mean)
Testosterone Undecanoate	4.114

[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

Intervention	ng/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.

Intervention	ng/dL (Geometric Mean)
Fasting	6.38
Very Low Fat Diet	6.73
Low Fat Diet	6.88
Normal Diet	7.00
High Fat Diet	7.18

[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

Intervention	grams (Mean)
	Lean Body Mass Baseline	Lean Body Mass Month 1	Lean Body Mass Month 2	Lean Body Mass Month 3	Lean Body Mass Month 4	Lean Body Month 5
Continuous Testosterone	57746	60469.3	62680.1	61167.3	61436.6	60871.4
Monthly Cycled Testosterone	57101	59155.4	56787.8	59186	59838.6	58846.9
Placebo	62344	62994.7	62038.7	62256.5	62755.4	61250.6

[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

Intervention	pounds (Mean)
	Arm Curl Baseline	Arm Extension Baseline	Leg Curl Baseline	Leg Extension Baseline	Arm Curl Month 1	Arm Curl Month 2	Arm Curl Month 3	Arm Curl Month 4	Arm Curl Month 5	Arm Extension Month 1	Arm Extension Month 2	Arm Extension Month 3	Arm Extension Month 4	Arm Extension Month 5	Leg Curl Month 1	Leg Curl Month 2	Leg Curl Month 3	Leg Curl Month 4	Leg Curl Month 5	Leg Extension Month 1	Leg Extension Month 2	Leg Extension Month 3	Leg Extensuion Month 4	Leg Extension Month 5
Continuous Testosterone	32	38	40	66	34	39	37	41	38	37	44	44	44	45	41	48	48	50	51	67	78	76	82	83
Monthly Cycled Testosterone	39	41	44	73	41	40	43	43	45	41	42	43	44	45	46	47	43	50	50	73	77	80	79	85
Placebo	39	40	46	70	39	38	39	38	40	40	41	42	42	42	48	51	48	48	48	70	69	74	72	72

[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

Intervention	nM BCE (Bone Collagen Equivalents) (Mean)
	NTX Baseline	NTX Five Months	TRAP5b Baseline	TRAP5b Five Months	Osteocalcin Baseline	Osteocalcin Five Months	BAP Baseline	BAP Five Months	iPTH Baseline	iPTH Five Months	Calcitonin Baseline	Calcitonin Five months
Continuous Testosterone	15	11	2	1	9	7	17	15	53	60	4	3
Monthly Cycled Testosterone	14	11	2	2	8	8	20	19	37	28	4	4
Placebo	12	13	2	2	8	8	22	21	40	45	3	3

[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

Intervention	pg/mL (Mean)
	IL-B1 Baseline	IL-B1 Five Months	IL-2 Baseline	IL-2 Five Months	IL-5 Baseline	IL-5 Five Months	IL-6 Baseline	IL-6 Five months	IL-7 Baseline	IL-7 Five Months	IL-8 Baseline	IL-8 Five months	IL-10 Baseline	IL-10 Five Months	IL-12 Baseline	IL-12 Five Months	IL-13 baseline	IL-13 Five Months	IFN gamma Baseline	IFN gamma Five Months	GM-CSF Baseline	GM-CSF Five Months	TNF alpha Baseline	TNF alpha Five Months
Continuous Testosterone	1.44143	2.538	2.538	3.862	1.41875	1.94125	10.4025	13.89	5.19875	16.2763	8.45625	11.8025	109.446	135.64	35.3583	58.4217	60.2125	73.674	23.425	36.822	7.94875	14.965	13.215	15.4138
Monthly Cycled Testosterone	0.475	3.19	3.19	1.45333	0.79	0.32286	4.90857	6.487	11.9688	23.1888	6.66375	4.06286	11.2588	8.34143	4.242	2.66	23.33	12.72	4.58	1.758	2.4	1.312	10.0863	8.1529
Placebo	0.14	0.20833	1.32	2.84	0.6	0.705	5.68375	5.05	8.78	7.68	4.5575	4.3225	22.6363	25.4525	7.075	10.902	37.045	43.465	10.115	36.05	1.52429	2.27857	9.0175	8.14

[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

Intervention	Percent per hour (%/hr) (Mean)
	Baseline	Five Months
Continuous Testosterone	0.06	0.101
Monthly Cycled Testosterone	0.06	0.094
Placebo	0.05	0.066

[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

Intervention	gm/cm^2 (Mean)
	Total Baseline	Total Five Months	Lumbar Spine Baseline	Lumbar Spine Five Months	Pelvis baseline	Pelvis Five Months	Forearm Baseline	Forearm Five Months
Continuous Testosterone	1.12	1.14	1.16	1.19	1.27	1.28	0.61	0.62
Monthly Cycled Testosterone	1.07	1.05	1.00	1.00	1.15	1.14	0.59	0.59
Placebo	1.12	1.08	1.06	1.07	1.46	1.28	0.59	0.61

[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

Intervention	mg/dL (Mean)
Testosterone Injection	104.0
Testosterone Gel	94.57
Medrol 6 Day Dose Pack	87.5
Testosterone Injection and Medrol 6 Day Dose Pack	75.14

[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

Intervention	ng/mL (Mean)
Testosterone Injection	1.92
Testosterone Gel	2.33
Medrol 6 Day Dose Pack	1.85
Testosterone Injection and Medrol 6 Day Dose Pack	1.83

[back to top]

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

Intervention	ng/mL (Mean)
Testosterone Injection	1.98
Testosterone Gel	2.32
Medrol 6 Day Dose Pack	1.78
Testosterone Injection and Medrol 6 Day Dose Pack	2.07

[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

Intervention	pg/mL (Mean)
Testosterone Injection	22.86
Testosterone Gel	33.69
Medrol 6 Day Dose Pack	36.33
Testosterone Injection and Medrol 6 Day Dose Pack	34.71

[back to top]

Serum Estradiol Measured on Treatment Day 8 (Post Study)

Intervention	pg/mL (Mean)
Testosterone Injection	48.29
Testosterone Gel	33.43
Medrol 6 Day Dose Pack	30.83
Testosterone Injection and Medrol 6 Day Dose Pack	47.14

[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

Intervention	ng/dL (Mean)
Testosterone Injection	307.57
Testosterone Gel	363.43
Medrol 6 Day Dose Pack	408.17
Testosterone Injection and Medrol 6 Day Dose Pack	318.68

[back to top]

Serum Total Testosterone Measured on Treatment Day 2

Intervention	ng/dL (Mean)
Testosterone Injection	980.86
Testosterone Gel	526.71
Medrol 6 Day Dose Pack	191.87
Testosterone Injection and Medrol 6 Day Dose Pack	675.86

[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

Intervention	ng/dL (Mean)
Testosterone Injection	828.71
Testosterone Gel	527.43
Medrol 6 Day Dose Pack	206.0
Testosterone Injection and Medrol 6 Day Dose Pack	673.29

[back to top]

Serum Total Testosterone Measured on Treatment Day 4

Intervention	ng/dL (Mean)
Testosterone Injection	779.57
Testosterone Gel	441.71
Medrol 6 Day Dose Pack	271.6
Testosterone Injection and Medrol 6 Day Dose Pack	734.57

[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

Intervention	ng/dL (Mean)
Testosterone Injection	722.0
Testosterone Gel	460.14
Medrol 6 Day Dose Pack	246.33
Testosterone Injection and Medrol 6 Day Dose Pack	669.71

[back to top]

Serum Total Testosterone Measured on Treatment Day 6

Intervention	ng/dL (Mean)
Testosterone Injection	629.0
Testosterone Gel	536.43
Medrol 6 Day Dose Pack	284.5
Testosterone Injection and Medrol 6 Day Dose Pack	645.14

[back to top]

Serum Total Testosterone Measured on Treatment Day 7

Intervention	ng/dL (Mean)
Testosterone Injection	578.29
Testosterone Gel	485.86
Medrol 6 Day Dose Pack	320.0
Testosterone Injection and Medrol 6 Day Dose Pack	579.57

[back to top]

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

Intervention	ng/dL (Mean)
Testosterone Injection	454.29
Testosterone Gel	435.14
Medrol 6 Day Dose Pack	340.17
Testosterone Injection and Medrol 6 Day Dose Pack	481.14

[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

Intervention	nmol/L (Mean)
Testosterone Injection	21.78
Testosterone Gel	19.86
Medrol 6 Day Dose Pack	25.66
Testosterone Injection and Medrol 6 Day Dose Pack	24.70

[back to top]

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

Intervention	nmol/L (Mean)
Testosterone Injection	17.62
Testosterone Gel	20.13
Medrol 6 Day Dose Pack	19.22
Testosterone Injection and Medrol 6 Day Dose Pack	14.57

[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

Intervention	mg/dL (Mean)
Testosterone Injection	171.29
Testosterone Gel	165.57
Medrol 6 Day Dose Pack	168.00
Testosterone Injection and Medrol 6 Day Dose Pack	156.71

[back to top]

Total Cholesterol Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	172
Testosterone Gel	162.86
Medrol 6 Day Dose Pack	166.17
Testosterone Injection and Medrol 6 Day Dose Pack	141.86

[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

Intervention	mg/dL (Mean)
Testosterone Injection	140.42
Testosterone Gel	164.0
Medrol 6 Day Dose Pack	122.5
Testosterone Injection and Medrol 6 Day Dose Pack	119.71

[back to top]

Triglycerides Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	112.57
Testosterone Gel	160.0
Medrol 6 Day Dose Pack	155.17
Testosterone Injection and Medrol 6 Day Dose Pack	116.28

[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

Intervention	mg/dL (Mean)
Testosterone Injection	28
Testosterone Gel	33.14
Medrol 6 Day Dose Pack	24.67
Testosterone Injection and Medrol 6 Day Dose Pack	23.86

[back to top]

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

Intervention	mg/dL (Mean)
Testosterone Injection	26.71
Testosterone Gel	29.29
Medrol 6 Day Dose Pack	31.0
Testosterone Injection and Medrol 6 Day Dose Pack	24.71

[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

Intervention	ug/dL (Mean)
Testosterone Injection	7.84
Testosterone Gel	5.97
Medrol 6 Day Dose Pack	6.28
Testosterone Injection and Medrol 6 Day Dose Pack	5.19

[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

Intervention	mg/dL (Mean)
Testosterone Injection	0.47
Testosterone Gel	0.33
Medrol 6 Day Dose Pack	0.32
Testosterone Injection and Medrol 6 Day Dose Pack	0.4

[back to top]

C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)

Intervention	mg/dL (Mean)
Testosterone Injection	0.47
Testosterone Gel	0.31
Medrol 6 Day Dose Pack	0.32
Testosterone Injection and Medrol 6 Day Dose Pack	0.3

[back to top]

Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol

Intervention	ug/dL (Mean)
Testosterone Injection	7.71
Testosterone Gel	7.20
Medrol 6 Day Dose Pack	4.76
Testosterone Injection and Medrol 6 Day Dose Pack	4.15

[back to top]

Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol

Intervention	ug/dL (Mean)
Testosterone Injection	7.25
Testosterone Gel	6.00
Medrol 6 Day Dose Pack	6.64
Testosterone Injection and Medrol 6 Day Dose Pack	6.28

[back to top]

Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol

Intervention	ug/dL (Mean)
Testosterone Injection	7.05
Testosterone Gel	6.28
Medrol 6 Day Dose Pack	4.40
Testosterone Injection and Medrol 6 Day Dose Pack	5.78

[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

Intervention	ug/dL (Mean)
Testosterone Injection	46.34
Testosterone Gel	34.16
Medrol 6 Day Dose Pack	62.55
Testosterone Injection and Medrol 6 Day Dose Pack	46.07

[back to top]

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

Intervention	ug/dL (Mean)
Testosterone Injection	37.96
Testosterone Gel	35.54
Medrol 6 Day Dose Pack	34.74
Testosterone Injection and Medrol 6 Day Dose Pack	36.07

[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)

Intervention	units on a scale (Mean)
Testosterone Injection	1.84
Testosterone Gel	1.79
Medrol 6 Day Dose Pack	2.19
Testosterone Injection and Medrol 6 Day Dose Pack	1.57

[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

Intervention	percent (Mean)
Testosterone Injection	39.17
Testosterone Gel	38.4
Medrol 6 Day Dose Pack	40.45
Testosterone Injection and Medrol 6 Day Dose Pack	39.86

[back to top]

Hematocrit Measured on Treatment Day 8 (Post Study)

Intervention	percent (Mean)
Testosterone Injection	38.74
Testosterone Gel	37.23
Medrol 6 Day Dose Pack	40.53
Testosterone Injection and Medrol 6 Day Dose Pack	39.24

[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)

Intervention	units on a scale (Mean)
Testosterone Injection	2.25
Testosterone Gel	1.47
Medrol 6 Day Dose Pack	2.26
Testosterone Injection and Medrol 6 Day Dose Pack	1.86

[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

Intervention	mg/dL (Mean)
Testosterone Injection	40.29
Testosterone Gel	38.86
Medrol 6 Day Dose Pack	46.50
Testosterone Injection and Medrol 6 Day Dose Pack	42.14

[back to top]

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

Intervention	mg/dL (Mean)
Testosterone Injection	41.29
Testosterone Gel	36.71
Medrol 6 Day Dose Pack	47.67
Testosterone Injection and Medrol 6 Day Dose Pack	43.43

[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

Intervention	ng/mL (Mean)
Testosterone Injection	71.77
Testosterone Gel	69.2
Medrol 6 Day Dose Pack	61.42
Testosterone Injection and Medrol 6 Day Dose Pack	90.74

[back to top]

Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)

Intervention	ng/mL (Mean)
Testosterone Injection	80.16
Testosterone Gel	72.11
Medrol 6 Day Dose Pack	69.17
Testosterone Injection and Medrol 6 Day Dose Pack	54.86

[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

Intervention	uIu/mL (Mean)
Testosterone Injection	8.53
Testosterone Gel	10.28
Medrol 6 Day Dose Pack	4.09
Testosterone Injection and Medrol 6 Day Dose Pack	9.89

[back to top]

Insulin Measured on Treatment Day 8 (Post Study)

Intervention	uIu/mL (Mean)
Testosterone Injection	7.47
Testosterone Gel	10.58
Medrol 6 Day Dose Pack	3.92
Testosterone Injection and Medrol 6 Day Dose Pack	3.89

[back to top]

Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)

Intervention	mg/dL (Mean)
Testosterone Injection	103.0
Testosterone Gel	93.57
Medrol 6 Day Dose Pack	96.83
Testosterone Injection and Medrol 6 Day Dose Pack	90.71

[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)

Intervention	units on a scale (Mean)
	FACIT-F Total Score (29 days-baseline)	FACIT-F Fatigue Subscale (29 days-baseline)
Placebo	13	14
Testosterone	12	12

[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)

Intervention	units on a scale (Mean)
	Anxiety, ESAS	Depression, HADS	Well being, ESAS	Sleep, ESAS	Appetite, ESAS	Dyspnea, ESAS	Drowsiness, ESAS	Nausea, ESAS	Fatigue, ESAS	Pain, ESAS
Placebo	5	6	3	4	4	3	4	2	6	3
Testosterone	7	7	5	5	5	2	5	2	6	3

[back to top]

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

(NCT01084759)
Timeframe: 3 months

Intervention	Percentage of Participants (Number)
Treatment Group	42.9

[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

Intervention	participants (Number)
Treatment Group	7

[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

Intervention	days (Median)
Treatment Group	221

[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

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	-29.0

[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

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	-2.38

[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

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	115.7

[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

Intervention	Percent Change (Mean)
AndroGel (Testosterone Gel) 1%	-21.5

[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

Intervention	percentage of Arterial stiffness (Mean)
Testosterone	1.067

[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

Intervention	units on a scale (Mean)
Testosterone	0.06

[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

Intervention	units on a scale (Mean)
Testosterone	5.05

[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

Intervention	units on a scale (Mean)
Testosterone	0.106

[back to top]

Cavg of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Intervention	ng/dL (Mean)
10.0 mg of TBS-1, 4.0% T.I.D.	413
13.5 mg of TBS-1, 4.5% B.I.D	408
11.25 mg of TBS-1, 4.5% T.I.D	396

[back to top]

Cmax of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Intervention	ng/dL (Mean)
10.0 mg Testosterone t.i.d.	830
13.5 mg Testosterone b.i.d.	1050
11.25 mg Testosterone t.i.d.	883

[back to top]

AUC0-t of Serum Testosterone

(NCT01252745)
Timeframe: 24 hours

Intervention	ng.h/dL (Mean)
10.0 mg Testosterone t.i.d.	9920.07
13.5 mg Testosterone b.i.d.	9781.39
11.25 mg Testosterone t.i.d.	9505.03

[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

Intervention	units on a scale (Mean)
Placebo/Low Protein	0.14
Placebo/High Protein	-0.14
Testosterone/Low Protein	-0.53
Testosterone/High Protein	1.05

[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

Intervention	watts (Mean)
Placebo/Low Protein	26.9
Placebo/High Protein	96.9
Testosterone/Low Protein	61.5
Testosterone/High Protein	81.7

[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

Intervention	kg (Mean)
Placebo/Low Protein	0.14
Placebo/High Protein	0.74
Testosterone/Low Protein	4.43
Testosterone/High Protein	4.13

[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

Intervention	meters per second (Mean)
Placebo/Low Protein	0.15
Placebo/High Protein	0.11
Testosterone/Low Protein	0.06
Testosterone/High Protein	0.08

[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

Intervention	meters (Mean)
Placebo/Low Protein	44.2
Placebo/High Protein	49.9
Testosterone/Low Protein	38.2
Testosterone/High Protein	25.5

[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

,,,

Intervention	watts (Mean)
	Unloaded	Loaded
Placebo/High Protein	55.4	83.7
Placebo/Low Protein	50.8	56.8
Testosterone/High Protein	4.2	26.9
Testosterone/Low Protein	53.2	56.6

[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

Intervention	units on a scale (Mean)
Placebo/Low Protein	-0.56
Placebo/High Protein	1.17
Testosterone/Low Protein	0.32
Testosterone/High Protein	2.68

[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

Intervention	units on a scale (Mean)
Placebo/Low Protein	-1.4
Placebo/High Protein	-5.5
Testosterone/Low Protein	2.1
Testosterone/High Protein	-2.9

[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

,,,

Intervention	units on a scale (Mean)
	Affects Expressiveness Index (AEI)	Positive Total score (PTOT)	Negative Total score (NTOT)
Placebo/High Protein	1.45	2.10	-0.65
Placebo/Low Protein	0.65	1.38	-1.50
Testosterone/High Protein	-3.17	1.89	-5.53
Testosterone/Low Protein	-0.50	0.69	-0.88

[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

,,,

Intervention	newton (Mean)
	Maximal voluntary strength in leg press	Maximal voluntary strength in chest press
Placebo/High Protein	156.0	16.6
Placebo/Low Protein	134.6	41.5
Testosterone/High Protein	191.4	59.3
Testosterone/Low Protein	201.8	64.5

[back to top]

Progesterone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.09
Arm 2	0.08
Arm 3	0.06
Arm 4	0.08
Arm 5	0.09
Arm 6	0.07

[back to top]

17-OHPreg

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	1.19
Arm 2	1.25
Arm 3	1.23
Arm 4	1.05
Arm 5	1.02
Arm 6	1.36

[back to top]

Dihydrotestosterone (DHT)

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/mL (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	0.3
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	0.6
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	0.9
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	1.0
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	1.5
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	1.8

[back to top]

Androsterone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.17
Arm 2	0.15
Arm 3	0.12
Arm 4	0.17
Arm 5	0.17
Arm 6	0.21

[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

Intervention	units on a scale (Median)
Arm 1	1
Arm 2	2
Arm 3	2.5
Arm 4	0
Arm 5	2.5
Arm 6	4

[back to top]

Serum Testosterone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/mL (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	4.6
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	1.9
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	3.4
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	3.5
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	6.1
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	7.7

[back to top]

Prostate Volume

(NCT01327495)
Timeframe: 12 weeks

Intervention	cm^3 (Median)
Arm 1	19
Arm 2	18
Arm 3	19
Arm 4	15
Arm 5	16
Arm 6	20

[back to top]

Prostate Tissue Testosterone Concentrations After Treatment

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

Intervention	ng/g (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	0.3
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	0.13
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	0.125
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	0.18
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	0.195
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	0.3

[back to top]

Prostate Tissue DHT Concentrations After Treatment

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

Intervention	ng/g (Median)
Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel	4.05
Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g	4.26
Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5	2.99
Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g	3.88
Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g	4.12
Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g	5.11

[back to top]

DHEA

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	29.3
Arm 2	26.2
Arm 3	22.1
Arm 4	26.8
Arm 5	24.4
Arm 6	18.6

[back to top]

17-OHP

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.05
Arm 2	0.05
Arm 3	0.05
Arm 4	0.05
Arm 5	0.05
Arm 6	0.05

[back to top]

Androstenedione

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	0.16
Arm 2	0.11
Arm 3	0.12
Arm 4	0.13
Arm 5	0.18
Arm 6	0.14

[back to top]

Prostate Specific Antigen

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/dL (Median)
Arm 1	0.82
Arm 2	0.48
Arm 3	0.61
Arm 4	0.58
Arm 5	0.52
Arm 6	0.76

[back to top]

Pregnenolone

(NCT01327495)
Timeframe: 12 weeks

Intervention	ng/g (Median)
Arm 1	28.7
Arm 2	29.5
Arm 3	32.7
Arm 4	32.4
Arm 5	27.9
Arm 6	23.9

[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

Intervention	ng/dL (Mean)
Medium Dose TBS-2 - Multiple Dose	0.944

[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

Intervention	ng*h/dL (Geometric Mean)
Low Dose TBS-2 Single Dose	223.981
Medium Dose TBS-2 Single Dose	328.002
High Dose TBS-2 Single Dose	834.391
Medium Dose TBS-2 Multiple-Dose	553.325

[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

Intervention	pg*h/mL (Geometric Mean)
Low Dose TBS-2 - Single Dose	105.763
Medium Dose TBS-2 - Single Dose	75.97
High Dose TBS-2 - Single Dose	43.97
Medium Dose TBS-2 - Multiple Dose	400.264

[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

Intervention	ng/dL (Geometric Mean)
Low Dose TBS-2 - Single Dose	34.058
Medium Dose TBS-2 - Single Dose	62.880
High Dose TBS-2 - Single Dose	113.912
Medium Dose TBS-2 - Multiple Dose	137.555

[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

Intervention	ng*h/dL (Geometric Mean)
Low Dose TBS-2 - Single Dose	23.515
Medium Dose TBS-2 - Single Dose	38.457
High Dose TBS-2 - Single Dose	85.180
Medium Dose TBS-2 - Multiple Dose	122.194

[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

Intervention	Percent change (Mean)
	LUMBAR SPINE	TOTAL HIP	FEMORAL NECK
Subjects With Diabetes Mellitus	4.05	1.81	1.63
Subjects Without Diabetes Mellitus	3.28	0.53	-0.55

[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

Intervention	PERCENT CHANGE (Mean)
	LUMBAR SPINE	FEMORAL NECK	TOTAL HIP
CC Genotype for the rs1062033	3.74	0.22	0.64
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	2.85	0.64	0.70
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene	4.72	-1.04	0.33

[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

Intervention	Percent change (Mean)
	lumbar spine	Total hip	femoral neck
BMI Group 1	3.00	0.14	0.71
BMI Group 2	4.90	1.74	-0.33
BMI Group 3	3.90	-0.27	0.16

[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

Intervention	Percent change (Mean)
	C-telopeptide	Osteocalcin
GC Genotype for the rs1062033 Polymorphism of the	5.89	-20.59
GG Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene	-14.49	-26.96
GG Genotype for the rs1062033 Polymorphism of the CYP19A1 Gene	48.96	33.59

[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

Intervention	Percentage Changes (Mean)
	C-telopeptide	Osteocalcin
Subjects With Diabetes Mellitus	73.55	20.54
Subjects Without Diabetes Mellitus	2.05	-6.62

[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

Intervention	percent change (Mean)
	Lumbar spine	Total hip	Femoral neck
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	3.82	0.08	-1.25
GA Genotype for the rs700518 Polymorphisms of the CYP19A1 Gene	4.13	0.93	1.51
GG Genotype for RS 700518 Polymorphism of the CYP19A1 Gene	3.69	0.38	-1.09

[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

Intervention	perecent change (Mean)
	C-teloepetide	Osteocalcin
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	-9.75	-7.27
GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	3.35	-31.22
GG Genotype for RS 700518 of the CYP19A1 Gene	41.47	12.40

[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

Intervention	percent change (Mean)
GG Genotype for the rs700518 Polymorphism in the cYP19A1 Gene	25.0
GA Genoypr for the rs700518 Polymorphism of the CYP19A1 Gene	65.25
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	113.33

[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

Intervention	percent change (Mean)
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene	11.56
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	9.67
CC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	9.46

[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

Intervention	Percent change (Mean)
GG Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	11.32
GA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	9.71
AA Genotype for the rs700518 Polymorphism of the	9.41

[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

Intervention	precent change (Mean)
GG Genotype of the rs1062033 Polymorphism in the CYP19A1 Gene	85.15
GC Genotype of rs1062033 Polymorphism in the CYP19A1 Gene	62.86
CC Genotype for the rs1062033 Polymorphism in the CYP19A1 Gene	52.93

[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

Intervention	percent change (Mean)
GG Genotype for the rs700518 Polymor[Hism of the CYP19A1 Gene	105.78
GA Genotype of the rs700518 Polymorphism in CYP19A1 Gen	58.52
AA Genotype for the rs700518 Polymorphism of the CYP19A1 Gene	44.44

[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

,,,

Intervention	mIU/mL (Mean)
	Morning FSH at Baseline	Morning FSH at Week 2	Morning FSH Change from Baseline at Week 2	Morning FSH at Week 4	Morning FSH Change from Baseline at Week 4	Morning FSH at Week 6	Morning FSH Change from Baseline at Week 6
AndroGel	6.38	3.80	-2.58	3.72	-2.66	3.35	-3.03
Androxal 12.5 mg	5.63	7.77	2.14	7.12	1.48	8.19	2.56
Androxal 25 mg	6.31	11.41	5.09	12.34	6.03	13.45	7.14
Androxal 6.25 mg	4.61	6.18	1.60	6.45	1.66	5.69	1.42

[back to top]

Change in Leuteinizing Hormone (LH)

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

,,,

Intervention	mIU/mL (Mean)
	Morning LH at Baseline	Morning LH at Week 2	Morning LH Change from Baseline at Week 2	Morning LH at Week 4	Morning LH Change from Baseline at Week 4	Morning LH at Week 6	Morning LH Change from Baseline at Week 6
AndroGel	3.57	2.00	-1.57	1.88	-1.69	2.2	-1.41
Androxal 12.5 mg	4.82	8.60	3.78	7.20	2.38	8.2	3.39
Androxal 25 mg	4.98	9.64	4.66	11.78	6.79	14.5	9.51
Androxal 6.25 mg	3.63	5.49	1.99	6.92	3.43	6.1	2.60

[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

Intervention	Number of Subjects (Number)
Androxal Pooled Dose Levels	35

[back to top]

Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.

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

Intervention	h (Mean)
Androxal 6.25 mg	2.33
Androxal 12.5 mg	2.42
Androxal 25 mg	2.41

[back to top]

Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.

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

Intervention	ng/mL (Mean)
Androxal 6.25 mg	1.8154
Androxal 12.5 mg	3.3899
Androxal 25 mg	16.2993

[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

Intervention	ng*h/mL (Mean)
Androxal 6.25 mg	21.200
Androxal 12.5 mg	34.012
Androxal 25 mg	150.51

[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

,,,

Intervention	ng/dL (Mean)
	TTavg at Baseline	TTavg at Week 6	TTmax at Baseline	TTmax at Week 6
AndroGel	322.4	543.9	562.3	930.1
Androxal 12.5 mg	373.6	460.8	513.7	607.5
Androxal 25 mg	298.3	586.7	425.9	764.3
Androxal 6.25 mg	262.3	392.4	358.5	524.5

[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

Intervention	Participants (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

Intervention	percentage of partipants (Geometric Mean)
Oral Testosterone Undecanoate (TU)	83.6
Topical Testosterone Gel	79.2

[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

Intervention	Participants (Count of Participants)
	Cmax <=1500 ng/dL	1800 ng/dL <= Cmax <=2500 ng/dL	Cmax >2500 ng/dL
TBS-1 - b.i.d.	107	6	1
TBS-1 - b.i.d./t.i.d.	77	2	0
TBS-1 - t.i.d.	58	1	0

[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

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

[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

Intervention	percent change of bone mineral density (Mean)
Testosterone and Placebo Alendronate	2.52
Alendronate and Placebo Testosterone	0.61
Testosterone and Alendronate	3.16

[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

Intervention	kg (Mean)
	6 weeks post op	12 weeks post op	24 weeks post op
Placebo	-0.1	0.01	1.05
Testosterone	2.8	2.16	2.13

[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

Intervention	score on a scale (Mean)
	6 weeks post op	12 weeks post op	24 weeks post op
Placebo	65.5	73.2	86.6
Testosterone	63.2	76.7	84

[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

Intervention	Nm (Mean)
	6 weeks post op	12 weeks post op	24 weeks post op
Placebo	-33.4	-6.6	19.0
Testosterone	-53.5	-18.3	19.2

[back to top]

Body Composition

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

Intervention	percentage of fat mass (Mean)
	Baseline	Post-Intervention (After 16 weeks)
RT+Tp	31.84	30.75
Testosteroe Replacement Patches (Tp)	33.4	32.12

[back to top]

Metabolic Profile

Basal Metabolic Rate (NCT01652040)
Timeframe: 16 weeks

Intervention	kcal/day (Mean)
	Baseline	Post-Intervention (After 16 weeks)
RT+Tp	1525	1665
Testosterone Replacement Patches (Tp)	1491	1502

[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

Intervention	gene copy number per ng RNA (Mean)
Acyline + Placebo Gel + Placebo Pills	7493
Acyline + Testosterone Gel (1.25g/d) + Placebo Pills	8224
Acyline + Testosterone Gel (5g/d) + Placebo Pills	7885
Acyline + Testosterone Gel (5g/d) + Letrozole	8320

[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

Intervention	units on a scale (Median)
Acyline & Placebo Gel & Placebo Pill	5.0
Acyline & Testosterone Gel 1.25g/d & Placebo Pill	9.4
Acyline & Testosterone Gel 5g/d & Placebo Pill	7.2
Acyline & Testosterone Gel & Letrozole	7.3

[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

,,,

Intervention	kg (Mean)
	Change in fat mass	Change in lean mass
Acyline & Placebo Gel & Placebo Pill	1.1	-1.2
Acyline & Testosterone Gel & Letrozole	0.5	-0.3
Acyline & Testosterone Gel 1.25g/d & Placebo Pill	0.7	-1.4
Acyline & Testosterone Gel 5g/d & Placebo Pill	-0.4	0.0

[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

Intervention	mg/dL (Mean)
Oral TU	0.2
Transdermal T-gel	8.2

[back to top]

Absolute Change From Baseline in LDL

Intervention	mg/dL (Mean)
Oral TU	-1.5
Transdermal T-gel	6.0

[back to top]

Absolute Change From Baseline in Prostate Volume

Intervention	cc (Mean)
Oral TU	1.09
Transdermal T-gel	0.40

[back to top]

Absolute Change From Baseline in Hct

Intervention	percent (Mean)
Oral TU	0.38
Transdermal T-gel	0.37

[back to top]

Absolute Change From Baseline in HDL

Intervention	mg/dL (Mean)
Oral TU	2.4
Transdermal T-gel	4.0

[back to top]

Absolute Change From Baseline in Hgb

Intervention	g/dL (Mean)
Oral TU	0.36
Transdermal T-gel	0.36

[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

Intervention	participants (Number)
ADT Plus IM Testosterone	17

[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

Intervention	pg/ml (Mean)
ADT Plus IM Testosterone	-159.77

[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

Intervention	participants (Number)
	Patients with radiographic/clinical progression	Patients without radiographic/clinical progression
ADT Plus IM Testosterone	6	23

[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

Intervention	units on a scale (Median)
	Change in SF-36 after round 1 of BAT	Change in FACT-P after round 1 of BAT	Change in IIEF after round 1 of BAT	Change in IPSS after round 1 of BAT
ADT Plus IM Testosterone	3.2	3.5	10	0

[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

Intervention	participants (Number)
	Patients with PSA <0.2 ng/ml	Patients with PSA ≥0.2 ng/ml
ADT Plus IM Testosterone	3	26

[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.

Intervention	kg (Mean)
	Following ADT lead in	Following round 1 of BAT
ADT Plus IM Testosterone	2.08	1.21

[back to top]

Change in Waist Circumference

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

Intervention	cm (Mean)
	Following ADT lead in	Following round 1 of BAT
ADT Plus IM Testosterone	3.9	-1.09

[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

Intervention	Participants (Count of Participants)
Oral Testosterone Undecanoate	87

[back to top]

Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population

Intervention	Participants (Count of Participants)
	Cmax less that 1500 ng/dL	Cmax between 1500 and 1800 ng/dL	Cmax >1800 to 2500 ng/dL	Cmax >2500 ng/dL
Oral Testosterone Undecanoate	95	10	7	4

[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

Intervention	units on a scale (Mean)
Testosterone	45.1
Placebo	47.5

[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

Intervention	units on a scale (Mean)
Testosterone	4.0
Placebo	3.7

[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

Intervention	units on a scale (Mean)
Testosterone	15.3
Placebo	14.1

[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

Intervention	participants (Number)
	Double-Blind Baseline (n=350, 347)	Week 12 (n=289, 299)	Open Label Baseline (n=269, 278)	Week 36 (n=219, 223)
Placebo Solution	1	3	0	4
Testosterone Solution	0	4	0	4

[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

Intervention	units on a scale (Least Squares Mean)
Placebo Solution	7.5
Testosterone Solution	10.5

[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

Intervention	units on a scale (Least Squares Mean)
Placebo Solution	6.3
Testosterone Solution	11.4

[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

Intervention	participants (Number)
Placebo Solution	43
Testosterone Solution	217

[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

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

[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

Intervention	participants (Number)
QuickShot™ - 100 mg Treatment A	10
QuickShot™ - 50 mg Treatment B	12
Delatestryl 200 mg IM Treatment C	3

[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

Intervention	ng*hr/dL (Mean)
QuickShot™ - 100 mg Treatment A	150445.2
QuickShot™ - 50 mg Treatment B	70955.7
Delatestryl 200 mg IM Treatment C	278657.9

[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

Intervention	ng/dL (Mean)
QuickShot™ - 100 mg Treatment A	895.5
QuickShot™ - 50 mg Treatment B	422.4
Delatestryl 200 mg IM Treatment C	1658.7

[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

Intervention	ng/dL (Mean)
QuickShot™ - 100 mg Treatment A	1345.6
QuickShot™ - 50 mg Treatment B	622.4
Delatestryl 200 mg IM Treatment C	261.9

[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)

Intervention	ng/dL (Mean)
Topical Testosterone Solution	354.8

[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

Intervention	percentage of participants (Number)
	Very much better - Day 15 (n=76)	Much better - Day 15 (n=76)	A little better - Day 15 (n=76)	No change - Day 15 (n=76)	A little worse - Day 15 (n=76)	Much worse - Day 15 (n=76)	Very much worse - Day 15 (n=76)	Very much better - Day 22 (n=76)	Much better - Day 22 (n=76)	A little better - Day 22 (n=76)	No change - Day 22 (n=76)	A little worse - Day 22 (n=76)	Much worse - Day 22 (n=76)	Very much worse - Day 22 (n=76)	Very much better - Day 36 (n=22)	Much better - Day 36 (n=22)	A little better - Day 36 (n=22)	No change - Day 36 (n=22)	A little worse - Day 36 (n=22)	Much worse - Day 36 (n=22)	Very much worse - Day 36 (n=22)	Very much better - Day 43 (n=22)	Much better - Day 43 (n=22)	A little better - Day 43 (n=22)	No change - Day 43 (n=22)	A little worse - Day 43 (n=22)	Much worse - Day 43 (n=22)	Very much worse - Day 43 (n=22)	Very much better - Day 57 (n=6)	Much better - Day 57 (n=6)	A little better - Day 57 (n=6)	No change - Day 57 (n=6)	A little worse - Day 57 (n=6)	Much worse - Day 57 (n=6)	Very much worse - Day 57 (n=6)	Very much better - Day 64 (n=6)	Much better - Day 64 (n=6)	A little better - Day 64 (n=6)	No change - Day 64 (n=6)	A little worse - Day 64 (n=6)	Much worse - Day 64 (n=6)	Very much worse - Day 64 (n=6)	Very much better - Endpoint (n=77)	Much better - Endpoint (n=77)	A little better - Endpoint (n=77)	No change - Endpoint (n=77)	A little worse - Endpoint (n=77)	Much worse - Endpoint (n=77)	Very much worse - Endpoint (n=77)
Topical Testosterone Solution	3.95	11.84	44.74	38.16	1.32	0.00	0.00	5.26	25.00	39.47	30.26	0.00	0.00	0.00	0.00	22.73	45.45	31.82	0.00	0.00	0.00	4.55	22.73	36.36	31.82	4.55	0.00	0.00	0.00	50.00	0.00	50.00	0.00	0.00	0.00	16.67	33.33	0.00	50.00	0.00	0.00	0.00	7.79	27.27	35.06	28.57	1.30	0.00	0.00

[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

Intervention	percentage of participants (Number)
	Very much better - Day 15 (n=75)	Much better - Day 15 (n=75)	A little better - Day 15 (n=75)	No change - Day 15 (n=75)	A little worse - Day 15 (n=75)	Much worse - Day 15 (n=75)	Very much worse - Day 15 (n=75)	Very much better - Day 22 (n=76)	Much better - Day 22 (n=76)	A little better - Day 22 (n=76)	No change - Day 22 (n=76)	A little worse - Day 22 (n=76)	Much worse - Day 22 (n=76)	Very much worse - Day 22 (n=76)	Very much better - Day 36 (n=22)	Much better - Day 36 (n=22)	A little better - Day 36 (n=22)	No change - Day 36 (n=22)	A little worse - Day 36 (n=22)	Much worse - Day 36 (n=22)	Very much worse - Day 36 (n=22)	Very much better - Day 43 (n=22)	Much better - Day 43 (n=22)	A little better - Day 43 (n=22)	No change - Day 43 (n=22)	A little worse - Day 43 (n=22)	Much worse - Day 43 (n=22)	Very much worse - Day 43 (n=22)	Very much better - Day 57 (n=6)	Much better - Day 57 (n=6)	A little better - Day 57 (n=6)	No change - Day 57 (n=6)	A little worse - Day 57 (n=6)	Much worse - Day 57 (n=6)	Very much worse - Day 57 (n=6)	Very much better - Day 64 (n=6)	Much better - Day 64 (n=6)	A little better - Day 64 (n=6)	No change - Day 64 (n=6)	A little worse - Day 64 (n=6)	Much worse - Day 64 (n=6)	Very much worse - Day 64 (n=6)	Very much better - Endpoint (n=77)	Much better - Endpoint (n=77)	A little better - Endpoint (n=77)	No change - Endpoint (n=77)	A little worse - Endpoint (n=77)	Much worse - Endpoint (n=77)	Very much worse - Endpoint (n=77)
Topical Testosterone Solution	4.00	16.00	44.00	36.00	0.00	0.00	0.00	7.89	27.63	40.79	22.37	1.32	0.00	0.00	4.55	18.18	50.00	22.73	4.55	0.00	0.00	4.55	27.27	40.91	22.73	4.55	0.00	0.00	0.00	33.33	50.00	16.67	0.00	0.00	0.00	16.67	16.67	33.33	33.33	0.00	0.00	0.00	10.39	29.87	35.06	22.08	2.60	0.00	0.00

[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)

Intervention	percentage of participants (Number)
Topical Testosterone Solution	94.7

[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

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	6
Cohort B: Post-abiraterone	2
Cohort C: Castration Only	4
Cohort D: Mutation	0

[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

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	9
Cohort B: Post-abiraterone	5
Cohort C: Castration Only	4
Cohort D: Mutation	2

[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

Intervention	months (Median)
Cohort A:Post-enzalutamide	3.3
Cohort B: Post-abiraterone	3.2
Cohort C: Castration Only	0.93
Cohort D: Mutation	3

[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

Intervention	months (Median)
Cohort A:Post-enzalutamide	5.5
Cohort B: Post-abiraterone	3.7
Cohort C: Castration Only	NA

[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

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	15
Cohort B: Post-abiraterone	3
Cohort D: Mutation	2

[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

Intervention	Participants (Count of Participants)
Cohort A:Post-enzalutamide	30
Cohort B: Post-abiraterone	29
Cohort C: Castration Only	29
Cohort D: Mutation	7

[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

Intervention	score on a scale (Mean)
	Baseline	Cycle 1 Day 85
Cohort A:Post-enzalutamide	13.28	10.64
Cohort B: Post-abiraterone	16.86	13.85
Cohort C: Castration Only	13	11.55

[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

Intervention	score on a scale (Mean)
	Baseline	BAT C1D85
Cohort A:Post-enzalutamide	8	24.13
Cohort B: Post-abiraterone	7.33	24.94
Cohort C: Castration Only	12.56	22.44

[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

Intervention	score on a scale (Mean)
	Baseline	BAT C1D85
Cohort A:Post-enzalutamide	46.15	45.1
Cohort B: Post-abiraterone	48	45.22
Cohort C: Castration Only	41.24	44.48

[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

Intervention	score on a scale (Mean)
	Baseline	Cycle 1 Day 85
Cohort A:Post-enzalutamide	72.23	71.76
Cohort B: Post-abiraterone	64.36	73.97
Cohort C: Castration Only	69.72	73.40

[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

Intervention	Participants (Count of Participants)
	Patients with any TEAE	Patients with any TEAE related to IP	Patients with any SAE	Patients with TEAE leading to discontinuation	Patients discontinued due to IP related TEAE	Patients with any adverse event leading to death
Testosterone Enanthate Auto-injector	125	66	3	30	1	1

[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

Intervention	Participants (Count of Participants)
Testosterone Enanthate Auto-injector	139

[back to top]

Vd/F (L)

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

Intervention	Liters (Mean)
	TT	TE
Testosterone Enanthate 200 mg	10959.5	62366.4
Testosterone Enanthate 50 mg	6655.8	NA

[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

Intervention	hours (Mean)
	TT	TE
Testosterone Enanthate 200 mg	131.75	133.00
Testosterone Enanthate 50 mg	261.73	NA

[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

Intervention	hours (Mean)
	TT	TE
Testosterone Enanthate 200 mg	19.00	74.00
Testosterone Enanthate 50 mg	40.51	82.01

[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

Intervention	ng/dL (Mean)
	Serum testosterone	Serum testosterone enanthate
Testosterone Enanthate 200 mg	1487.0	267.33
Testosterone Enanthate 50 mg	773.7	49.25

[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

Intervention	L/hr (Mean)
	TT	TE
Testosterone Enanthate 200 mg	60.46	352.84
Testosterone Enanthate 50 mg	18.07	NA

[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)
	TT	TE
Testosterone Enanthate 200 mg	176112.8	33535.5
Testosterone Enanthate 50 mg	103731.5	6122.2

[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)
	TT	TE
Testosterone Enanthate 200 mg	362627.4	62497.5
Testosterone Enanthate 50 mg	279062.2	NA

[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

Intervention	percent change (Mean)
	6 months	12 months
Placebo Treatment	-0.9	-1.9
Testosterone Enanthate, Finasteride	7.9	11.4

[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

Intervention	percent change (Mean)
	6 months	12 months
Placebo Treatment	-3.2	0.2
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

Intervention	percent change (Mean)
	6 months	12 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

Intervention	percent change (Mean)
	6 months	12 months
Placebo Treatment	-8.6	0.5
Testosterone Enanthate, Finasteride	19.9	15.5

[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

Intervention	percent change (Mean)
	Change at 6 months	Change at 12 months
Placebo Treatment	-0.5	1.1
Testosterone Enanthate, Finasteride	1.7	1.2

[back to top]

Absolute Change in Walking Speed

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

Intervention	meters/second (m/s) change (Mean)
	6 months	12 months
Placebo Treatment	0.05	0.01
Testosterone Enanthate, Finasteride	0	0.10

[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

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	1.29	1.19	1.67	1.57	0.76
Arm B: Enzalutamide	1.20	1.94	1.62	1.81	1.13

[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

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	63.16	61.68	62.34	63.49	67.35
Arm B: Enzalutamide	61.89	56.94	55.34	58.67	59.65

[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

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	13.89	14.28	14.44	14.26	14.24
Arm B: Enzalutamide	13.96	14.90	15.43	14.80	13.48

[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

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	5.75
Arm B: Enzalutamide	8.28

[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

Intervention	month (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	2.79
Arm B: Enzalutamide	3.81

[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

Intervention	score on a scale (Mean)
	EF - baseline to month 1	EF - baseline to month 3	EF - baseline to month 6	EF - baseline to month 12	OF - baseline to month 1	OF - baseline to month 3	OF - baseline to month 6	OF - baseline to month 12	SD - baseline to month 1	SD - baseline to month 3	SD - baseline to month 6	SD - baseline to month 12	IS - baseline to month 1	IS - baseline to month 3	IS - baseline to month 6	IS - baseline to month 12	OS - baseline to month 1	OS - baseline to month 3	OS - baseline to month 6	OS - baseline to month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	1.17	2.65	2.36	2.5	0.91	1.93	2.19	2.93	0.97	1.85	2.52	2.38	0.36	1.55	0.74	2.40	0.65	1.13	0.60	2.00
Arm B: Enzalutamide	0.09	0.05	0.65	0.05	0.25	-0.02	0.04	0.17	-0.27	0.10	0.18	0.30	-0.01	0.05	0.08	0.00	0.17	0.25	-0.09	0.20

[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

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	33.99	33.72	33.23	33.96	36.24
Arm B: Enzalutamide	32.35	32.33	31.48	31.84	29.88

[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

Intervention	score on a scale (Mean)
	Baseline	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	1.22	1.55	2.00	1.96	1.04
Arm B: Enzalutamide	1.27	2.26	1.94	1.84	1.70

[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

Intervention	score on a scale (Mean)
	Month 1	Month 3	Month 6	Month 12
Arm A: Testosterone Cypionate or Testosterone Enanthate	38.13	38.39	39.23	41.67
Arm B: Enzalutamide	32.60	33.51	34.51	34.58

[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

Intervention	Participants (Count of Participants)
Arm A: Testosterone Cypionate or Testosterone Enanthate	14
Arm B: Enzalutamide	18

[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

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	28.2
Arm B: Enzalutamide	19.6

[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

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	5.62
Arm B: Enzalutamide	5.72

[back to top]

Overall Survival

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

Intervention	months (Median)
Arm A: Testosterone Cypionate or Testosterone Enanthate	32.9
Arm B: Enzalutamide	29

[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

Intervention	Participants (Count of Participants)
Arm A: Testosterone Cypionate or Testosterone Enanthate	8
Arm B: Enzalutamide	1

[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

Intervention	change in standard score (Mean)
Testosterone Treatment	2.8
No Treatment	2.0

[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

Intervention	raw score (Mean)
Testosterone Treatment	10.5
No Treatment	8.9

[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

Intervention	cm (Mean)
Testosterone Treatment	0.9
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

Intervention	kg (Mean)
Testosterone Treatment	1.4
No Treatment	0.6

[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

Intervention	score on a scale (Mean)
Testosterone Treatment	-0.12
No Treatment	0.92

[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

Intervention	pg/ml (Mean)
Testosterone Treatment	244
No Treatment	355

[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

Intervention	mIU/mL (Mean)
Testosterone Treatment	2.5
No Treatment	2.5

[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

Intervention	ng/dl (Mean)
Testosterone Treatment	181
No Treatment	166

[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

Intervention	mIU/mL (Mean)
Testosterone Treatment	1.8
No Treatment	1.7

[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

Intervention	pmol/l (Mean)
Testosterone Treatment	1377
No Treatment	2208

[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

Intervention	Participants (Count of Participants)
	Patients with any TEAE	Patients with any TEAE related to QST	Patients with SAE	Patients with TEAE leading to Discontinuation	Patients with QST related TEAE and discontinuation
Testosterone Enanthate Auto-injector	87	34	4	8	4

[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.

Intervention	Difference as % of Mean of T results (Mean)
	NAF+EDTA	NAF+Oxalate	NAF
Oral Testosterone Undecanoate	8.6	16.6	23.2

[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

Intervention	seconds (Number)
Placebo	1.08
Testosterone	1.01

[back to top]

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

Intervention	seconds (Number)
Placebo	1.08
Testosterone	2.02

[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

Intervention	kg (Number)
Placebo	0.8
Testosterone	2.5

[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

Intervention	meters/second (Number)
Placebo	0.10
Testosterone	0.48

[back to top]

Change in Handgrip Strength

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

Intervention	kg (Number)
Placebo	-5.0
Testosterone	5.0

[back to top]

Change in Hip Abduction Strength (Supine)

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

Intervention	kg (Number)
Placebo	0.9
Testosterone	2.6

[back to top]

Change in Knee Extension Strength (Seated)

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

Intervention	kg (Number)
Placebo	1.7
Testosterone	5.9

[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

Intervention	seconds (Number)
Placebo	10
Testosterone	10

[back to top]

Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline

Intervention	seconds (Number)
Placebo	0
Testosterone	0

[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

Intervention	seconds (Number)
Placebo	10
Testosterone	10

[back to top]

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

Intervention	seconds (Number)
Placebo	0
Testosterone	10

[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

Intervention	seconds (Number)
Placebo	0
Testosterone	2.6

[back to top]

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

Intervention	seconds (Number)
Placebo	0
Testosterone	0

[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

Intervention	ng/dL (Mean)
	TE Period 1 400 mg QD	TU Period 2 200 mg QD	TU Period 3 100 mg BID	TU Period 4 200 mg BID	TE Period 5 400 mg BID
Testosterone Enanthate and Testosterone Undecanoate	140	122	97.9	114	127

[back to top]

Mean Serum Testosterone Cavg

Intervention	ng/dL (Mean)
	TE Period 1 400 mg QD	TU Period 2 200 mg QD	TU Period 3 100 mg BID	TU Period 4 200 mg BID	TE Period 5 400 mg BID
Testosterone Enanthate and Testosterone Undecanoate	293	246	281	385	316

[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

Intervention	Participants (Count of Participants)
Oral Testosterone Undecanoate	145
Axiron Testosterone Topical Solution	48

[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

Intervention	Participants (Count of Participants)
Oral TU Cosyntropin Substudy Subjects	19
Axiron Cosyntropin Substudy Subjects	8

[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

Intervention	kilograms (Least Squares Mean)
	Total Body Mass at end of Phase 1	Total Body Mass at end of Phase 2	Total Body Mass at end of Phase 3	Fat-free Mass at end of Phase 1	Fat-free Mass at end of Phase 2	Fat-free Mass at end of Phase 3	Fat Mass at end of Phase 1	Fat Mass at end of Phase 2	Fat Mass at end of Phase 3
Energy Deficit	78.3	73.3	76.5	58.3	58.0	60.5	16.8	12.2	12.8
Energy Deficit + Testosterone	78.0	75.8	79.3	57.9	60.4	63.1	16.8	12.0	12.8

[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

Intervention	Participants (Count of Participants)
	Patients with any TEAE	Patients with any TEAE related to QST	Patients with SAE	Patients with TEAE leading to discontinuation	Patients with QST related TEAE and discontinuation
Testosterone Enanthate Auto-injector	5	1	0	0	0

[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

Intervention	ng/dL (Geometric Mean)
Breakfast A - Fasting	160.0
Breakfast B - 15 g Fat	203.7
Breakfast C - 30 g Fat	275.1
Breakfast D - 45 g Fat	285.1
Breakfast E - High Fat	267.3

[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

Intervention	ng*hr/dL (Geometric Mean)
Breakfast A - Fasting	1905
Breakfast B - 15 g Fat	2428
Breakfast C - 30 g Fat	3279
Breakfast D - 45 g Fat	3395
Breakfast E - High Fat	3187

[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

Intervention	ng/dL (Geometric Mean)
Breakfast A - Fasting	250.7
Breakfast B - 15 g Fat	334.7
Breakfast C - 30 g Fat	529.7
Breakfast D - 45 g Fat	506.0
Breakfast E - High Fat	463.4

[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

Intervention	hours (Median)
Breakfast A - Fasting	4.000
Breakfast B - 15 g Fat	2.000
Breakfast C - 30 g Fat	2.000
Breakfast D - 45 g Fat	2.000
Breakfast E - High Fat	2.000

[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

Intervention	Units on a scale (Mean)
Non-naive Patients - BID Treatment	4.8
Naive Patients - BID Treatment	12.0
Non-naive Patients - TID Treatment	3.9
Naive Patients - TID Treatment	6.8

[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

Intervention	Units on a scale (Mean)
	Effectiveness Domain Change from Baseline	Convenience Domain Change from Baseline	Global Satisfaction Domain Change from Baseline
Natesto Testosterone Intranasal Gel Given BID	9.6	18.9	-0.6
Natesto Testosterone Intranasal Gel Given TID	21.5	21.9	13.3

[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"

Intervention	ng/dl (Number)
	visit 2	visit 3	visit 4	vist 5	visit 6	visit 7
"IM"	1043.6	785.7	NA	NA	NA	NA
"SQ"	NA	NA	203.5	1367.9	980.8	144.7

[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"

Intervention	nmol/l (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	25.5	22	NA	NA	NA	NA
"SQ"	NA	NA	27.8	24.8	22.9	20.7

[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"

Intervention	miu/ml (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	0.4	0.3	NA	NA	NA	NA
"SQ"	NA	NA	0.2	0.04	0.1	0.4

[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"

Intervention	miu/ml (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	1.3	0.4	NA	NA	NA	NA
"SQ"	NA	NA	0.2	0.1	0.05	0.3

[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"

Intervention	pg/mL (Number)
	visit 2	visit 3	visit 4	visit 5	visit 6	visit 7
"IM"	70.03	52.00	NA	NA	NA	NA
"SQ"	NA	NA	30.06	45.12	64.74	25.99

[back to top]

Change in Levels of Whole Blood Hematocrit

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

Intervention	g/dL (Number)
"SQ"	NA
"IM"	1.9

[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)"

Intervention	ng/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)"

Intervention	ng/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

Intervention	mIU/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

Intervention	ng/dL (Mean)
Combination Therapy	8.26

[back to top]

Mean Change in Level of TSH in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	uIU/mL (Mean)
Combination Therapy	0.37

[back to top]

Mean Change in Level of Free Testosterone in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	pg/mL (Mean)
Combination Therapy	17.42

[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

Intervention	Participants (Count of Participants)
Combination Therapy	14

[back to top]

Mean Change in Total Lean Body Mass

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	Kg (Mean)
Combination Therapy	2.21

[back to top]

Mean Change in Level of FSH in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	mIU/mL (Mean)
Combination Therapy	-3.29

[back to top]

Mean Change in Level of IGF-1 in the Blood

(NCT03123913)
Timeframe: Baseline to 24 weeks

Intervention	ng/mL (Mean)
Combination Therapy	89.79

[back to top]

Incidence of Adverse Events

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

Intervention	Participants (Count of Participants)
	Azoospermia	Severe Oligospermia	Nasal irritation	sinusitis	epistaxis
Natesto	1	3	5	1	1

[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

Intervention	pg/mL (Mean)
Natesto	21.6

[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

Intervention	million sperm/mL (Mean)
Natesto	33.9

[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

Intervention	ng/dL (Mean)
Natesto	652

[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

Intervention	Participants (Count of Participants)
Natesto	32

[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

Intervention	mIU/mL (Mean)
	Follicle Stimulating Hormone	Luteinizing Hormone
Natesto	3.0	2.6

[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

Intervention	Percent of participants (Number)
Oral Testosterone Undecanoate, LPCN 1021	69

[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

Intervention	Percent of participants (Number)
Oral Testosterone Undecanoate, LPCN 1021	80

[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

Intervention	Participants (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.

Intervention	Participants (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

Intervention	Participants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab	5

[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

Intervention	months (Number)
Bipolar Androgen Therapy + Nivolumab	4.0

[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

Intervention	percentage of overall participants (Number)
Bipolar Androgen Therapy + Nivolumab	18

[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

Intervention	Participants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab	18

[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

Intervention	Participants (Count of Participants)
Bipolar Androgen Therapy + Nivolumab	15

[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

Intervention	months (Median)
Bipolar Androgen Therapy + Nivolumab	5.6

[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

Intervention	months (Median)
Bipolar Androgen Therapy + Nivolumab	24.4

[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)

Intervention	bpm (Mean)
LPCN 1021	0.44

[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)

Intervention	mmHg (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)

Intervention	mmHg (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)

Intervention	mmHg (Mean)
LPCN 1021	2.6

[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)

Intervention	mmHg (Mean)
LPCN 1021	4.8

[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)

Intervention	mmHg (Mean)
LPCN 1021	1.7

[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)

Intervention	bpm (Mean)
LPCN 1021	2.6

[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)

Intervention	mmHg (Mean)
LPCN 1021	5.2

[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)

Intervention	mmHg (Mean)
LPCN 1021	1.7

[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)

Intervention	mmHg (Mean)
LPCN 1021	4.3

[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 is SBP Dip

Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5 (NCT03868059)
Timeframe: Baseline to End of Study (approximately 4 months)

Intervention	mmHg (Mean)
LPCN 1021	0.5

[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)

Intervention	units on a scale (Mean)
LPCN 1021	-0.3

[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)

Intervention	mmHg (Mean)
LPCN 1021	1.2

[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).

Intervention	mmHg (Mean)
LPCN 1021	3.8

[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)

Intervention	percentage of hematocrit (Mean)
LPCN 1021	3.2

[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)

Intervention	g/dL (Mean)
LPCN 1021	0.87

[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)

Intervention	mmHg (Mean)
LPCN 1021	1.6

[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)

Intervention	bpm (Mean)
LPCN 1021	2.0

[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)

Intervention	mmHg (Mean)
LPCN 1021	4.8

[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)

Intervention	units on a scale (Mean)
LPCN 1021	1.2

[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)

Intervention	bpm (Mean)
LPCN 1021	2.0

[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)

Intervention	Participants (Count of Participants)
LPCN 1021	2

[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)

Intervention	cm (Least Squares Mean)
	Vertical Jump Height, Phase 1	Vertical Jump Height, Phase 2	Vertical Jump Height, Phase 3
Placebo	53.6	50.0	50.5
Testosterone	54.5	49.1	54.0

[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)

Intervention	kg (Least Squares Mean)
	Total Mass Lifted, Phase 1	Total Mass Lifted, Phase 2	Total Mass Lifted, Phase 3
Placebo	127.9	119.0	129.8
Testosterone	127.4	122.7	126.7

[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)

Intervention	L/min (Least Squares Mean)
	VO2peak, absolute, Phase 1	VO2peak, absolute, Phase 2	VO2peak, absolute, Phase 3
Placebo	3.28	3.20	3.44
Testosterone	3.22	3.13	3.29

[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)

Intervention	min (Least Squares Mean)
	2.5 mile time, Phase 1	2.5 mile time, Phase 2	2.5 mile time, Phase 3
Placebo	41.58	47.15	39.34
Testosterone	45.21	50.95	44.31

[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)

Intervention	kg (Least Squares Mean)
	Fat-free Mass at end of Phase 1	Fat-free Mass at end of Phase 2	Fat-free Mass at end of Phase 3	Fat Mass at end of Phase 1	Fat Mass at end of Phase 2	Fat Mass at end of Phase 3
Placebo	59.8	57.9	59.6	17.5	14.4	15.5
Testosterone	59.2	59.6	59.5	17.3	13.0	15.1

[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)

Intervention	W (Least Squares Mean)
	Wingate peak power, absolute, Phase 1	Wingate peak power, absolute, Phase 2	Wingate peak power, absolute, Phase 3
Placebo	837.8	736.0	790.8
Testosterone	879.4	753.8	821.8

[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

Intervention	Percentage change (Least Squares Mean)
Treatment A	2.75
Treatment B	1.90
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

Intervention	Participants (Count of Participants)
Treatment A	9
Treatment B	8
Treatment C	2

[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

Intervention	Participants (Count of Participants)
Treatment A	12
Treatment B	6
Treatment C	5

[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

Intervention	Participants (Count of Participants)
Treatment A	6
Treatment B	8
Treatment C	3

[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

Intervention	Participants (Count of Participants)
Treatment A	4
Treatment B	2
Treatment C	6

[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

Intervention	Participants (Count of Participants)
Treatment A	6
Treatment B	9
Treatment C	0

[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

Intervention	Participants (Count of Participants)
Treatment A	7
Treatment B	9
Treatment C	1

[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

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

[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

Intervention	Percentage change (Least Squares Mean)
Treatment A	-3.68
Treatment B	-7.33
Treatment C	1.78

[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

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

[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.

Intervention	NAS score (Least Squares Mean)
	Hepatocyte ballooning score	Lobular inflammation score	Steatosis score
Treatment A	-0.7	-0.2	-0.9
Treatment B	-0.9	-0.5	-1.2
Treatment C	-0.2	-0.1	-0.1

[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

Intervention	mg/dL (Least Squares Mean)
	Total Cholesterol	LDL	HDL	Triglycerides
Treatment A	-1.7	1.8	-3.3	-11.5
Treatment B	7.3	8.7	-2.0	-3.9
Treatment C	1.1	-6.0	-0.0	67.3

[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

Intervention	U/L (Least Squares Mean)
	Aspartate transaminase (AST)	Alanine transaminase (ALT)	Alkaline phosphatase (ALP)	Gamma-glutamyltransferase (GGT)
Treatment A	-8.0	-11.4	-6.1	-2.9
Treatment B	-12.0	-22.9	-8.5	-13.4
Treatment C	1.3	0.6	0.1	0.7

[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

Intervention	ng/dL (Mean)
	Testosterone	17-OHP
Natesto Group	283	-8.8
Testosterone Cypionate Group	511	-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

Intervention	score on a scale (Mean)
Testosterone Cypionate Group	4.8
Natesto Group	0.2

[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

Intervention	ng/mL (Mean)
Testosterone Cypionate Group	0.6
Natesto Group	0.05

[back to top]

Change in Hematocrit (Hct) Levels.

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

Intervention	percentage of hematocrit (Mean)
Testosterone Cypionate Group	3.0
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

Intervention	pg/mL (Mean)
Testosterone Cypionate Group	22.9
Natesto Group	1.1

[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

Intervention	hematocrit percentage (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	42.8	46.7	45.8	43
Testopel 75mg Group	43.7	46.1	45.9	46

[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

Intervention	pg/mL (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	20.6	42.7	18.4	18.8
Testopel 75mg Group	18.2	29.1	13.7	14.3

[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

Intervention	ng/dL (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	202.3	696.5	277	241
Testopel 75mg Group	219.5	543	290	209

[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

Intervention	ng/mL (Median)
	Baseline	Month 2	Month 4	Month 6
Compounded Testosterone Pellets 100mg Group	0.4	0.75	0.65	0.5
Testopel 75mg Group	0.9	1.1	1	0.8

[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

Intervention	pg/mL (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	14.4	21.6	21.2

[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

Intervention	ng/mL (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	1.06	1.14	0.95

[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

Intervention	score on a scale (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	66.7	83.1	83.7

[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

Intervention	score on a scale (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	36.6	34.4	35.5

[back to top]

Hematocrit Levels

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

Intervention	percentage of hematocrit (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	44.9	45	45.2

[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

Intervention	ng/dL (Mean)
	Baseline	Month 3	Month 6
Jatenzo Arm	200.3	486.8	649.3

[back to top]

testosterone undecanoate

Cross-References

Synonyms (81)

Research Excerpts

Overview

Effects

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Drug Classes (1)

Protein Targets (1)

Potency Measurements

Ceullar Components (1)

Research

Studies (392)

Market Indicators

Research Demand Index: 42.85

Study Types

Clinical Trials (223)

Trial Overview

Trial Outcomes

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

Markers of Bone Metabolism

Bone Mineral Density

Fat Free Mass (kg)

Upper Body Muscle Strength (1-RM, kg)

Power (Power Rig, Watts)

Physical Function (CS-PFP Total Score)

Lower Body Muscle Strength (1-RM, kg)

Fat Mass (kg)

Myocardial Perfusion

Endothelial Function

Resting Energy Expenditure

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

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

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

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

Whole Brain Atrophy Rate

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

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

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

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

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

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

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

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

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

Change in Weight From Baseline to Week 24 in Part C

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

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

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

Trough Assessments of Serum Total Testosterone Concentrations in Part C2

Serum Total Testosterone Concentrations in Part C2

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

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

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

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

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 Following the 4th Injection in Part C

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

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

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

Serum Total Testosterone Maximum Concentration in Part A

Serum Total Testosterone Maximum Concentration in Part B

Serum Total Testosterone Maximum Concentration in Part C2

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

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

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

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

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

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

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

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

Grip Strength kg

Geriatric Depression Scale

Dietary Protein Intake

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