Clinical trials: Hypogonadotropic Hypogonadism
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.
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
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.
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, 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
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
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
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.
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
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, 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.)
Hypogonadotropic Hypogonadism
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
- Trial name
- NCT00328926
- Testing
- Luveris® 75 IU, Luveris® 25 IU, Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- EMD Serono
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.
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.
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, 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
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
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
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
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.