Clinical trials: Hypogonadism
Hypogonadism
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.
- Trial name
- NCT00998933
- Testing
- Testosterone gel 1.62%
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Solvay Pharmaceuticals
Secondary Hypogonadism
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in…
- Trial name
- NCT02274181
- Testing
- Androxal
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
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.
Microdeletion Syndromes, Trisomy 21
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA
The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on…
- Conditions
- Microdeletion Syndromes, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- Microdel Triad (NCT02109770)
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Natera, 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.
Obesity Associated With Defects in Leptin-melanocortin Pathway
Open-Label Extension Study of Setmelanotide
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous…
- Trial name
- NCT06596135
- Testing
- Setmelanotide
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- Rhythm Pharmaceuticals, 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 Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and…
- Trial name
- NCT07097259
- Testing
- Test: Follitropin alfa, Reference: Follitropin alfa, Zoladex
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Hypogonadism, Hypogonadism, Male
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination…
- Trial name
- NCT00398580
- Testing
- Nanomilled testosterone, Nanomilled dutasteride, commercially available dutasteride
- Where
- 7 sites in United States
- Volunteers
- 43 people
- Sponsor
- GlaxoSmithKline
Hypothalamic Obesity, Prader-Willi Syndrome
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
- Conditions
- Hypothalamic Obesity, Prader-Willi Syndrome, PWS
- Trial name
- NCT06239116
- Testing
- Part C: RM-718, Part D: RM-718
- Where
- 7 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hypogonadism
Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation…
- Trial name
- NCT01133548
- Testing
- Testosterone Gel 1.62%
- Volunteers
- 62 people
- Sponsor
- AbbVie
Hypothalamic Obesity
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.
- Trial name
- NCT07156578
- Testing
- Bivamelagon
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
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
Secondary Hypogonadism
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary…
- Trial name
- NCT00962637
- Testing
- Androxal, AndroGel
- Where
- 18 sites in United States
- Volunteers
- 194 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism, Male
Vogelxo(R) ABPM Study in Hypogandal Men
A Phase 4 ABPM study in Hypogonadal Men
- Trial name
- NCT04558567
- Testing
- Vogelxo
- Where
- 7 sites in United States
- Volunteers
- 122 people
- Sponsor
- Upsher-Smith Laboratories
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).
- Trial name
- NCT00193661
- Testing
- Testosterone Gel (1%)
- Where
- 19 sites in United States
- Sponsor
- Solvay Pharmaceuticals
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