Clinical trials: 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.
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
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
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
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
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
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
Hypogonadism
A Study of the Pharmacokinetics of Testosterone Metered Dose (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 evaluate pharmacokinetics of…
- Trial name
- NCT00857961
- Testing
- Testosterone MD-Lotion
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Eli Lilly and Company
Hypogonadism
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine the effect of meals of various amounts of fat given immediately prior to dosing on the pharmacokinetics of oral testosterone undecanoate.
- Trial name
- NCT02921386
- Testing
- Oral Testosterone Undecanoate
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Clarus Therapeutics, 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
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.
Hypogonadism
Testosterone Treatment for Hypogonadal Men
Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men
- Trial name
- NCT00433199
- Testing
- Testosterone (T) Gel 1.62%
- Volunteers
- 274 people
- Sponsor
- Abbott
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
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
- Trial name
- NCT01323140
- Testing
- testosterone matrix transdermal system
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Watson Pharmaceuticals