Clinical trials: Hypogonadism, Male
Male Hypogonadism
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men
- Trial name
- NCT01446042
- Testing
- Testosterone
- Where
- 30 sites in United States
- Volunteers
- 306 people
- Sponsor
- Acerus Pharmaceuticals Corporation
Adult Male Hypogonadism
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
- Trial name
- NCT01703741
- Testing
- Testosterone Gel (FE 999093)
- Where
- 18 sites in United States, Canada
- Volunteers
- 145 people
- Sponsor
- Ferring Pharmaceuticals
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
Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.
- Trial name
- NCT02697188
- Testing
- Testosterone undecanoate, Testosterone enanthate
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Clarus Therapeutics, Inc.
Adult Male Hypogonadism
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
- Trial name
- NCT02149264
- Testing
- Testosterone gel (FE 999303)
- Where
- 22 sites in United States
- Volunteers
- 160 people
- Sponsor
- Ferring Pharmaceuticals
Hypogonadism, Male
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
- Trial name
- DV (NCT03242590)
- Testing
- LPCN 1021
- Volunteers
- 95 people
- Sponsor
- Lipocine Inc.
Hypogonadism
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
- Trial name
- NCT02504541
- Testing
- Testosterone enanthate auto-injector
- Where
- 20 sites in United States
- Volunteers
- 133 people
- Sponsor
- Antares Pharma Inc.
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
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
The goal of this study was to determine how well LB54640 (also known as bivamelagon) worked and how safe it was in participants with Hypothalamic Obesity (HO).
- Trial name
- NCT06046443
- Testing
- Bivamelagon
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hypogonadism, Male
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated…
- Trial name
- NCT03868059
- Testing
- LPCN 1021
- Where
- 16 sites in United States
- Volunteers
- 138 people
- Sponsor
- Lipocine Inc.
Male Hypogonadism
Safety and Efficacy Trial of Testosterone Undecanoate
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
- Trial name
- NCT01765179
- Testing
- Oral testosterone undecanoate
- Where
- 27 sites in United States
- Volunteers
- 144 people
- Sponsor
- Clarus Therapeutics, Inc.
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, Hypogonadism, Male
A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males
This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to: 1. evaluate the dose-response curve following ascending single doses of TSX-011; 2. confirm optimum dosing conditions; 3.
- Conditions
- Hypogonadism, Hypogonadism, Male, Gonadal Disorders, Endocrine System Diseases
- Trial name
- NCT03335254
- Testing
- TSX-011
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- TesoRx Pharma, LLC
Hypogonadism, Male
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)
This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
- Trial name
- DF (NCT03242408)
- Testing
- LPCN 1021
- Volunteers
- 100 people
- Sponsor
- Lipocine Inc.
Male Hypogonadism
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
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
- NCT01403116
- Testing
- Oral testosterone undecanoate, topical testosterone gel
- Where
- 30 sites in United States, Germany
- Volunteers
- 325 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadism
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
Evaluation of pharmacokinetics of subcutaneous testosterone enanthate
- Trial name
- NCT02233751
- Testing
- Testosterone enanthate auto-injector
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Antares Pharma Inc.
Ejaculatory Dysfunction, Hypogonadism
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.
- Trial name
- NCT01419236
- Testing
- Testosterone Solution 2%
- Where
- 7 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Eli Lilly and Company
Male Hypogonadism
Time to Eugonadal Range, Time to Steady State and Drying Time
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and…
- Trial name
- NCT01228071
- Testing
- testosterone gel 2%
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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
Oral Testosterone for the Treatment of Hypogonadism in Males
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors.
- Trial name
- NCT02222558
- Testing
- TSX-002
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- TesoRx Pharma, LLC