Clinical trials: Hypogonadotropism
Hypogonadism, Male
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
The purpose of this study is to evaluate changes in vascular parameters and the prevalence of side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of Testosterone Cypionate versus subjects receiving…
- Trial name
- NCT04439799
- Testing
- Testosterone Cypionate 200 Mg/ML, Intranasal Testosterone
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- University of Miami
Hypogonadism
CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy
Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the…
- Trial name
- NCT01378299
- Testing
- Testosterone Cypionate
- Where
- 2 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
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
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, 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, 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, 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
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.
Secondary Hypogonadism
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with…
- Trial name
- NCT01270841
- Testing
- topical testosterone, Androxal
- Where
- 18 sites in United States
- Volunteers
- 83 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism, Opioid-Related Disorders
Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration
The purpose of this randomized controlled clinical trial is to evaluate the effects of clomiphene citrate compared to placebo (substance without active medication) in men who are taking pain medication (opioids) for chronic pain…
- Conditions
- Hypogonadism, Opioid-Related Disorders, Male Infertility
- Trial name
- NCT01880086
- Testing
- Clomiphene citrate
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Weill Medical College of Cornell University
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.
Healthy
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood…
- Trial name
- Oral T8 (NCT01167829)
- Testing
- Oral Testosterone, Acyline
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Washington
Klinefelter Syndrome, XXY Syndrome
Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome
The purpose of this study is to determine if testosterone replacement therapy leads to changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also called Klinefelter syndrome).
- Trial name
- TestoXXY/KS (NCT01585831)
- Testing
- Testosterone gel 1%
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Colorado, Denver
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
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.
Chronic Pain, Opioid Addiction
Testosterone Replacement for Male Opioid Agonist Maintained Patients
This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction
- Conditions
- Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism
- Trial name
- NCT01873989
- Testing
- Testosterone replacement, Waitlist control
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Yale University
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.
Aging
Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents
Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle…
- Trial name
- NCT02679274
- Testing
- Testosterone
- Where
- 2 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston