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.
Testosterone Deficiency, Hypogonadism, Male
Subcutaneous vs. Intramuscular Testosterone
In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy.
- Trial name
- NCT03091348
- Testing
- Testosterone
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Men's Health Boston
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.
Klinefelter Syndrome
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition.
- Trial name
- NCT02408445
- Testing
- testosterone cypionate 200mg/ml
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Hypogonadism, Male, Physical Activity
Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male
This study examines the effect of 12-week strength training program with and without testosterone replacement therapy (TRT) on body composition, physical function, selected biochemical markers of metabolic health, molecular…
- Conditions
- Hypogonadism, Male, Physical Activity, Testosterone Deficiency
- Trial name
- NCT03282682
- Testing
- Strength training
- Where
- Slovakia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Comenius University
Hypogonadotropic Hypogonadism
Effect of Intranasal Insulin on LH Concentrations in Man
Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a condition called hypogonadotrophic hypogonadism (HH). People with this condition produce little or no sex hormones.
- Trial name
- NCT02154477
- Testing
- intranasal insulin
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Texas Tech University Health Sciences Center
Hypogonadism
Cycled Testosterone Replacement Study
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years.
- Trial name
- NCT00957528
- Testing
- Testosterone
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
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.
Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism
The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .
- Trial name
- NCT00467987
- Testing
- androgel
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University at Buffalo
Male Infertility, Klinefelter's Syndrome
RA-2 13-cis Retinoic Acid (Isotretinoin)
Men with infertility and normal hormone levels have few options for fertility treatment. Previous research work has suggested that men with infertility may have low levels of the active form of Vitamin A, called retinoic acid, in…
- Conditions
- Male Infertility, Klinefelter's Syndrome, Y-chromosome Microdeletions
- Trial name
- RA-2 (NCT02061384)
- Testing
- 13-cis retinoic acid, Calcitriol
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Washington
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.
Bladder Cancer, Low Testosterone Levels
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.
- Trial name
- NCT03063125
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Kansas Medical Center
Hypogonadism, Male
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week…
- Trial name
- CAP (NCT03933618)
- Testing
- Anastrozole 1mg, Clomiphene Citrate 25mg
- Volunteers
- 24 people
- Sponsor
- Albany Medical College