Clinical trials: Hypogonadotropic Hypogonadism
Hypogonadism
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.
- Trial name
- NCT00975650
- Testing
- Nasobol®, Androderm® (Positive Control)
- Where
- 6 sites in United States
- Volunteers
- 57 people
- Sponsor
- Acerus Pharmaceuticals Corporation
Secondary Hypogonadism
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.
- Trial name
- NCT01386606
- Testing
- Androxal (enclomiphene citrate), Testosterone
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Repros Therapeutics Inc.
Type 2 Diabetes Mellitus, Secondary Hypogonadism
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
- Trial name
- NCT01191320
- Testing
- Androxal
- Where
- 18 sites in United States
- Volunteers
- 102 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism
Testosterone Replacement in Men With Diabetes and Obesity
The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy.
- Trial name
- NCT01127659
- Testing
- testosterone
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- University at Buffalo
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
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
Secondary Hypogonadism
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.
- Trial name
- NCT00706719
- Testing
- 25 mg Androxal, Testim 1%
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Repros Therapeutics 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
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.
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
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
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
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
Obese Hypogonadotropic Hypogonadism
Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men
This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design.
- Trial name
- OHH (NCT01200862)
- Testing
- Investigational new drug company code: BGS649
- Where
- 5 sites in United States, Canada
- Volunteers
- 29 people
- Sponsor
- Mereo BioPharma
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, 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
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.
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.
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
Hypogonadism, Kallmann Syndrome
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small testicular size, low testosterone levels, no history of puberty, and infertility.
- Trial name
- NCT00064987
- Testing
- Testicular biopsy, gonadotropin releasing hormone (GnRH), follicle stimulating hormone (FSH)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)