Clinical trials: Hypogonadism, Hypogonadotropic
Male Hypogonadism, Primary Hypogonadism
Pharmacokinetic Study to Determine Time to Steady-state
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
- Conditions
- Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Trial name
- NCT00911586
- Testing
- Testosterone undecanoate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Clarus Therapeutics, Inc.
Secondary Hypogonadism, Sexual Dysfunction
Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men
To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.
- Conditions
- Secondary Hypogonadism, Sexual Dysfunction, Erectile Dysfunction
- Trial name
- NCT02443090
- Testing
- fispemifene
- Where
- 16 sites in United States
- Volunteers
- 160 people
- Sponsor
- NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Acquired Hypogonadotropic Hypogonadism, Obesity
A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic…
- Trial name
- NCT02651688
- Testing
- Enclomiphene
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Repros Therapeutics Inc.
Secondary Hypogonadism
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in…
- Trial name
- NCT02274181
- Testing
- Androxal
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism, Low Testosterone
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203.
- Trial name
- NCT01386567
- Testing
- Androxal (enclomiphene citrate), Testim (topical testosterone)
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadotropic Hypogonadism
Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)
The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in…
- Trial name
- NCT03019575
- Testing
- Corifollitropin alfa, hCG
- Where
- 15 sites in Brazil, Denmark and 4 more
- Volunteers
- 17 people
- Sponsor
- Organon and Co
Secondary Hypogonadism
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with the 12.5…
- Trial name
- NCT01993212
- Testing
- Androxal 12.5 mg or 25 mg, AndroGel 1.62%
- Where
- 8 sites in United States
- Volunteers
- 120 people
- Sponsor
- Repros Therapeutics Inc.
Primary Amenorrhea With Hypogonadotropic Hypogonadism
LutrePulse Hypogonadotropic Hypogonadism
To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo
- Trial name
- NCT01976728
- Testing
- Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
- Where
- 35 sites in United States, Canada
- Volunteers
- 39 people
- Sponsor
- Ferring Pharmaceuticals
Secondary Hypogonadism
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T<300 ng/dL) and normal sperm…
- Trial name
- NCT01532414
- Testing
- Androxal
- Where
- 23 sites in United States
- Volunteers
- 151 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation…
- Trial name
- NCT01084265
- Testing
- Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH), Human chorionic gonadotropin (hCG)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)
Pharmacokinetic Evaluation of Testosterone Gel (1%)
Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel.
- Trial name
- NCT00193700
- Testing
- Testosterone Gel (1%)
- Where
- 9 sites in United States
- Sponsor
- Solvay Pharmaceuticals
Secondary Hypogonadism
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.
- Trial name
- NCT01386606
- Testing
- Androxal (enclomiphene citrate), Testosterone
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Repros Therapeutics Inc.
Secondary Hypogonadism
Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
- Trial name
- NCT01534208
- Testing
- Androxal
- Where
- 31 sites in United States
- Volunteers
- 499 people
- Sponsor
- Repros Therapeutics Inc.
Secondary Hypogonadism
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.
- Trial name
- NCT00706719
- Testing
- 25 mg Androxal, Testim 1%
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism, Hypogonadotropic Hypogonadism
A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)
This study will assess if corifollitropin alfa (MK-8962), when administered in combination with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who remain azoospermic after treatment with hCG…
- Trial name
- NCT01709331
- Testing
- Corifollitropin alfa, hCG
- Volunteers
- 18 people
- Sponsor
- Organon and Co
Secondary Hypogonadism
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary…
- Trial name
- NCT00962637
- Testing
- Androxal, AndroGel
- Where
- 18 sites in United States
- Volunteers
- 194 people
- Sponsor
- Repros Therapeutics Inc.
Male Hypogonadism
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed…
- Trial name
- NCT02966652
- Testing
- DITEST, Testosterone undecanoate
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Neurocrine UK Limited
Secondary Hypogonadism
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
To determine the safety profile of Androxal in men with secondary hypogonadism.
- Trial name
- NCT01739582
- Testing
- Androxal
- Volunteers
- 300 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadotropic Hypogonadism
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks.
- Trial name
- NCT02730169
- Testing
- BGS649
- Where
- 63 sites in United States, Italy and 2 more
- Volunteers
- 271 people
- Sponsor
- Mereo BioPharma
Obese Hypogonadotropic Hypogonadism
Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men
This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design.
- Trial name
- OHH (NCT01200862)
- Testing
- Investigational new drug company code: BGS649
- Where
- 5 sites in United States, Canada
- Volunteers
- 29 people
- Sponsor
- Mereo BioPharma