Clinical trials: Hypogonadism, Male
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.)
Hypogonadism
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study.
- Trial name
- NCT02777242
- Testing
- Testosterone enanthate auto-injector
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Antares Pharma Inc.
Testicular Hypogonadism
Efficacy, Pharmacokinetics and Safety of Testosterone
This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.
- Trial name
- NCT01370369
- Testing
- Testosterone gel (FE 99903)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ferring 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
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
Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal…
- Trial name
- NCT01786473
- Testing
- Testogel 1%
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Laboratoires Besins International
Hypogonadism, Late Onset Hypogonadism
Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80
The purpose of this study is to evaluate whether DHT-Gel, when applied daily to the skin, can relieve the symptoms of low testosterone in men aged 55-80.
- Conditions
- Hypogonadism, Late Onset Hypogonadism, Low Testosterone
- Trial name
- NCT00163566
- Testing
- Dihydrotestosterone (0.7%) in hydroalcoholic gel
- Where
- 16 sites in United States
- Volunteers
- 128 people
- Sponsor
- ASCEND Therapeutics
Hypothalamic Obesity
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO).
- Trial name
- NCT05774756
- Testing
- Setmelanotide
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 143 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hypothalamic Obesity, Prader-Willi Syndrome
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
- Conditions
- Hypothalamic Obesity, Prader-Willi Syndrome, PWS
- Trial name
- NCT06239116
- Testing
- Part C: RM-718, Part D: RM-718
- Where
- 7 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hypogonadism
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector
- Trial name
- STEADY (NCT02159469)
- Testing
- Testosterone enanthate auto-injector
- Where
- 28 sites in United States
- Volunteers
- 150 people
- Sponsor
- Antares Pharma Inc.
Hypogonadism, Male
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month…
- Trial name
- NCT03198728
- Testing
- SOV2012-F1, AndroGel
- Where
- 36 sites in United States
- Volunteers
- 314 people
- Sponsor
- Marius Pharmaceuticals
Male Hypogonadism
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Trial name
- SOAR (NCT02081300)
- Testing
- Oral testosterone undecanoate, LPCN 1021, Topical testosterone gel 1.62 %
- Volunteers
- 315 people
- Sponsor
- Lipocine Inc.
Hypogonadism
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.
- Trial name
- NCT00695110
- Testing
- Oral testosterone undecanoate (TU) (300 mg T equivalents/dose), Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose), Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadism
NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers
In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol).
- Trial name
- NCT00647868
- Testing
- testosterone
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Acerus Pharmaceuticals Corporation
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
Hypothalamic Obesity
Open-Label Study of Setmelanotide in Hypothalamic Obesity
Open-label, single-arm study designed to evaluate the body weight response to setmelanotide administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).
- Trial name
- NCT04725240
- Testing
- Setmelanotide
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Rhythm Pharmaceuticals, 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
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Halozyme Therapeutics
Male Hypogonadism
Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.
- Trial name
- NCT01699178
- Testing
- Oral testosterone undecanoate, Transdermal testosterone gel (AndroGel)
- Where
- 30 sites in United States, Germany
- Volunteers
- 182 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadism, Erectile Dysfunction
Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction…
- Trial name
- NCT00415571
- Testing
- Fispemifene (once daily for 8 weeks)
- Where
- 14 sites in United States
- Volunteers
- 72 people
- Sponsor
- QuatRx Pharmaceuticals Company
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.