Clinical trials: Hypogonadism
Male Hypogonadism, Primary Hypogonadism
Pharmacokinetic Study to Determine Time to Steady-state
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
- Conditions
- Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Trial name
- NCT00911586
- Testing
- Testosterone undecanoate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Clarus Therapeutics, Inc.
Acquired Hypogonadotropic Hypogonadism, Obesity
A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic…
- Trial name
- NCT02651688
- Testing
- Enclomiphene
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Repros Therapeutics Inc.
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, Hypogonadotropic, Obesity
Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism
The investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant…
- Trial name
- NCT03490513
- Testing
- anastrozole (1 mg/day)
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Baylor College of Medicine
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.
Spinal Cord Injury, Hypogonadism
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in…
- Trial name
- NCT00266864
- Testing
- Testosterone Transdermal System (Androderm 5 mg patch)
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- VA Office of Research and Development
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.
Pain, Hypogonadism
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception
Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes.
- Trial name
- TAP (NCT00351819)
- Testing
- AndroGel
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Boston University
Hypogonadism, Cardiovascular Diseases
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.
- Trial name
- TRAVERSE (NCT03518034)
- Testing
- AndroGel®
- Where
- 384 sites in United States, Puerto Rico
- Volunteers
- 5,246 people
- Sponsor
- AbbVie
Healthy
TEAM: Testosterone Supplementation and Exercise in Elderly Men
The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.
- Trial name
- NCT00112151
- Testing
- LowT, Resistance Training, HighT
- Where
- United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Hypogonadotropic Hypogonadism
Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)
The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in…
- Trial name
- NCT03019575
- Testing
- Corifollitropin alfa, hCG
- Where
- 15 sites in Brazil, Denmark and 4 more
- Volunteers
- 17 people
- Sponsor
- Organon and Co
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
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
Hypothalamic Obesity
Effects of Exenatide on Hypothalamic Obesity
The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and…
- Trial name
- NCT01061775
- Testing
- Exenatide
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota
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
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
Hypogonadism
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the…
- Trial name
- NCT00702650
- Testing
- Testosterone MD-Lotion
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 155 people
- Sponsor
- Eli Lilly and Company
Hypogonadism, Osteopenia
Testosterone and Alendronate in Hypogonadal Men
This study will investigate the hypothesis that the combination of testosterone replacement and alendronate will improve bone density and parameters of bone quality more than either medication alone in older men with low…
- Conditions
- Hypogonadism, Osteopenia, Osteoporosis
- Trial name
- NCT01460654
- Testing
- Testosterone, Alendronate
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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.
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.