Clinical trials: Secondary Hypogonadism
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
Varicocele, Male Infertility
Intratesticular Artery Resistive Index Changes After Varicocelectomy
This study aims to evaluate how blood flow inside the testicles changes after surgery to correct a varicocele, and whether these changes correlate with improvements in semen quality and testosterone levels.
- Conditions
- Varicocele, Male Infertility, Secondary Hypogonadism
- Trial name
- NCT07517952
- Testing
- Microscopic Sub-inguinal Varicocelectomy
- Volunteers
- 40 people
- Sponsor
- Assiut University
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.
Hypogonadism, Primary Hypogonadism
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
- Conditions
- Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Trial name
- TU (NCT00467870)
- Testing
- Testosterone Undecanoate 750 mg, Testosterone Undecanoate 1000 mg
- Where
- United States
- Volunteers
- 531 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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.)
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
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.
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.
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
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.
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).
- Trial name
- NCT00193661
- Testing
- Testosterone Gel (1%)
- Where
- 19 sites in United States
- Sponsor
- Solvay Pharmaceuticals
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
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.
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.
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.
Type 2 Diabetes Mellitus, Secondary Hypogonadism
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
- Trial name
- NCT01191320
- Testing
- Androxal
- Where
- 18 sites in United States
- Volunteers
- 102 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
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.
- Trial name
- ZA-003Ext (NCT01067365)
- Testing
- Androxal
- Where
- 18 sites in United States
- Volunteers
- 104 people
- Sponsor
- Repros Therapeutics Inc.
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.
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.