Clinical trials: Hypogonadotropism
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.
Hypogonadotropic Hypogonadism
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
- Trial name
- NCT00328926
- Testing
- Luveris® 75 IU, Luveris® 25 IU, Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- EMD Serono
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
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation…
- Trial name
- NCT01084265
- Testing
- Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH), Human chorionic gonadotropin (hCG)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hypogonadism
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety…
- Trial name
- NCT00857454
- Testing
- Testosterone MD-Lotion
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- Eli Lilly and Company
Hypogonadism
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
This study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels [total…
- Trial name
- NCT01893281
- Testing
- Topical Testosterone Solution
- Where
- 21 sites in United States
- Volunteers
- 78 people
- Sponsor
- Eli Lilly and Company
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
Hypogonadism, Primary Hypogonadism
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
- Conditions
- Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Trial name
- TU (NCT00467870)
- Testing
- Testosterone Undecanoate 750 mg, Testosterone Undecanoate 1000 mg
- Where
- United States
- Volunteers
- 531 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Hypogonadotropic Hypogonadism
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
- Trial name
- NCT04648969
- Testing
- kisspeptin 112-121, GnRH
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Stephanie B. Seminara, MD
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
Hypogonadotropic Hypogonadism, Type 2 Diabetes
Hypogonadism in Young Men With Type 2 Diabetes
Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men.
- Trial name
- NCT01155518
- Testing
- testosterone, clomiphene
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- State University of New York at Buffalo
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
Phlebotomy Study of Testosterone Undecanoate
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800…
- Trial name
- NCT02670343
- Testing
- Oral Testosterone Undecanoate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadotropic Hypogonadism
A 6 Month Safety Extension Study of MBGS205
Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)
- Trial name
- NCT02908074
- Testing
- BGS649
- Where
- 37 sites in United States
- Volunteers
- 143 people
- Sponsor
- Mereo BioPharma
Obesity, Insulin Resistance
The Health Influences of Puberty (HIP) Study
The Health Influences of Puberty (HIP) Study is designed to explore the relationships between puberty and the onset of type 2 diabetes in adolescents.
- Conditions
- Obesity, Insulin Resistance, Gonadal Dysfunction, Type 2 Diabetes
- Trial name
- HIP (NCT01775813)
- Testing
- Metformin
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- University of Colorado, Denver
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