Clinical trials: Male Hypogonadism
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.
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
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.
Male Hypogonadism, Muscle Atrophy
5-Alpha Reductase and Anabolic Effects of Testosterone
The purpose of this study is to determine whether a higher-than-replacement dose of testosterone and finasteride can be combined to safely increase muscle strength in older men who have a low blood concentration of testosterone.
- Conditions
- Male Hypogonadism, Muscle Atrophy, Sarcopenia, Benign Prostate Hypertrophy
- Trial name
- NCT00475501
- Testing
- Testosterone Enanthate, Finasteride
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Seizure Disorder, Hypogonadism
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
The purpose of this study is to determine if treatment using a medication (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any active medication, when…
- Conditions
- Seizure Disorder, Hypogonadism, Erectile Dysfunction
- Trial name
- NCT00179517
- Testing
- Anastrozole 1mg
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Beth Israel Deaconess Medical Center
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
ESPRIT Study in Hypogonadal Men
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
- Trial name
- NCT01143818
- Testing
- AndroGel (testosterone gel) 1%
- Where
- 331 sites in Canada, Croatia and 7 more
- Volunteers
- 1,053 people
- Sponsor
- Abbott
Hypogonadism, Severe Obesity
Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)
After the age of 40, there is a gradual decline in the production of testosterone. Among obese men, the decline in testosterone levels is exacerbated by the suppression of the hypothalamic-pituitary-gonadal axis by…
- Trial name
- NCT02959853
- Testing
- Anastrazole, weight loss
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Baylor College of Medicine
Turner Syndrome, Hypogonadism
Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism
Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female.
- Conditions
- Turner Syndrome, Hypogonadism, Premature Ovarian Failure
- Trial name
- NCT00837616
- Testing
- 17 B estradiol orally, 17 B estradiol
- Where
- 3 sites in United States, Chile
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
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
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
Pharmacokinetic Study of Testosterone Enanthate
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
- Trial name
- NCT01887418
- Testing
- QuickShot™ - 50 mg Treatment B, QuickShot™ - 100 mg Treatment A, Delatestryl 200 mg IM Treatment C
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Antares Pharma Inc.
Adult Male Hypogonadism
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an…
- Trial name
- NCT01665599
- Testing
- Testosterone gel (FE 999303)
- Where
- 19 sites in United States, Canada
- Volunteers
- 180 people
- Sponsor
- Ferring Pharmaceuticals
Hypogonadism
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection…
- Trial name
- NCT03792477
- Testing
- Test formulation, Reference formulation
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hypogonadism, Benign Prostatic Hyperplasia
TRADE-Testosterone Replacement and Dutasteride Effectiveness
The purpose of this research study is to determine whether the combination of the male hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large prostate glands can safely reduce the size of the…
- Trial name
- TRADE (NCT00194675)
- Testing
- Dutasteride, Testosterone gel
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Washington
Hypogonadism, Hypogonadotropic
Hypogonadotropic Hypogonadism in Obese Young Males
Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene.
- Trial name
- NCT03245827
- Testing
- Clomiphene
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Sandeep Singh Dhindsa, M.D., F.A.C.E
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
Craniopharyngioma, Hypothalamic Obesity
Intranasal Oxytocin in Hypothalamic Obesity
This research study will test if oxytocin, delivered by nasal spray, will promote weight loss in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The study is divided into two parts.
- Trial name
- NCT02849743
- Testing
- Syntocinon
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Shana McCormack, MD
Contraception, Hypogonadism
ORAL T-6: Oral Androgens in Man-6
We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.
- Trial name
- ORAL-T-6 (NCT00663793)
- Testing
- Acyline, Testosterone, Finasteride
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Washington
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