Clinical trials: Hypogonadotrophic Hypogonadism
Secondary Hypogonadism
Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function
To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.
- Trial name
- NCT01923857
- Testing
- Androxal 25 mg
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- 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
Hypogonadism
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.
- Trial name
- NCT00975650
- Testing
- Nasobol®, Androderm® (Positive Control)
- Where
- 6 sites in United States
- Volunteers
- 57 people
- Sponsor
- Acerus Pharmaceuticals Corporation
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
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.
Secondary Hypogonadism
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with…
- Trial name
- NCT01270841
- Testing
- topical testosterone, Androxal
- Where
- 18 sites in United States
- Volunteers
- 83 people
- Sponsor
- Repros Therapeutics Inc.
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
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.
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 12.5 mg…
- Trial name
- NCT01993225
- Testing
- Androxal 12.5 mg/25 mg, AndroGel 1.62%
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism, Male, Secondary Hypogonadism
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
AIM-TEST is a randomized, double-blind, placebo-controlled clinical trial evaluating whether an AI-guided, microbiome-targeted nutritional intervention can increase the body's own testosterone production in men aged 30-65 years…
- Trial name
- AIM-TEST (NCT07761546)
- Testing
- Fixed-Formula Microbiome-Targeted Oral Nutritional Supplement
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people
- Sponsor
- Varol TUNALI
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
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
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
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
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function
To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
- Trial name
- NCT01923870
- Testing
- Androxal 25 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Repros 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.)
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
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.
Hypogonadotropic Hypogonadism
A 6 Month Safety Extension Study of MBGS205
Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)
- Trial name
- NCT02908074
- Testing
- BGS649
- Where
- 37 sites in United States
- Volunteers
- 143 people
- Sponsor
- Mereo BioPharma
Effect of Treatment on Bone Mineral Density
Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.
- Trial name
- NCT01619683
- Testing
- enclomiphene citrate
- Where
- 17 sites in United States
- Volunteers
- 300 people
- Sponsor
- Repros Therapeutics Inc.