Clinical trials: Hypogonadotrophic Hypogonadism
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.
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
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.
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
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
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 Hypogonadism, Hypogonadotropic Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
- Trial name
- NCT02110368
- Testing
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Male Hypogonadism
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.
- Trial name
- NCT00924612
- Testing
- Oral testosterone undecanoate (containing 300 mg T)
- Where
- 2 sites in United States, Canada
- Volunteers
- 16 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadism, Hypogonadism, Male
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Testosterone is the principal androgen produced by the male testes. Male Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of…
- Conditions
- Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
- Trial name
- NCT04456296
- Testing
- Aveed Injectable Product, Fortesta, Testim
- Where
- 35 sites in United States
- Volunteers
- 673 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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.
Hypogonadism, Male
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.
- Trial name
- NCT06689085
- Testing
- Testosterone enanthate
- Where
- 22 sites in United States
- Volunteers
- 100 people
- Sponsor
- Halozyme Therapeutics
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
Hypogonadotropic Hypogonadism
A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism
The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with…
- Trial name
- NCT02369796
- Testing
- TAK-448
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Takeda
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.
Idiopathic Hypogonadotropic Hypogonadism
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection
- Trial name
- NCT06561594
- Testing
- recombinant human follicle-stimulating hormone-CTP Fusion protein injection
- Where
- 17 sites in China
- Volunteers
- 60 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
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
Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism
The purpose of ZA-302 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
- NCT01739595
- Testing
- enclomiphene citrate
- Where
- 13 sites in United States
- Volunteers
- 181 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.