Clinical trials: Male Hypogonadism
Male Hypogonadism
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
The goal of this Phase 3 clinical trial is to evaluate the safety, efficacy, and usability of a weekly subcutaneous testosterone cypionate auto-injector in adult males with hypogonadism.
- Trial name
- NCT07898072
- Testing
- Testosterone Cypionate 75 mg, Testosterone cypionate 50 mg, Testosterone cypionate 100 mg
- Where
- 10 sites in United States
- Volunteers
- 190 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Primary Hypogonadism, Hypogonadotropic Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
- Trial name
- NCT02110368
- Testing
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Amneal Pharmaceuticals, LLC
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.
Male Hypogonadism
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.
- Trial name
- NCT00924612
- Testing
- Oral testosterone undecanoate (containing 300 mg T)
- Where
- 2 sites in United States, Canada
- Volunteers
- 16 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadism
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
This study will evaluate the effect of a once daily Androderm® dose on Blood Pressure (BP) in adult hypogonadal men as measured by 24-hour ABPM.
- Trial name
- NCT04320745
- Testing
- Androderm®
- Where
- 41 sites in United States
- Volunteers
- 168 people
- Sponsor
- Allergan
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, Hypogonadism, Male
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Testosterone is the principal androgen produced by the male testes. Male Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of…
- Conditions
- Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
- Trial name
- NCT04456296
- Testing
- Aveed Injectable Product, Fortesta, Testim
- Where
- 35 sites in United States
- Volunteers
- 673 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Hypogonadism, Male
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.
- Trial name
- NCT06689085
- Testing
- Testosterone enanthate
- Where
- 22 sites in United States
- Volunteers
- 100 people
- Sponsor
- Halozyme Therapeutics
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
Hypogonadism, Erectile Dysfunction
Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction…
- Trial name
- NCT00415571
- Testing
- Fispemifene (once daily for 8 weeks)
- Where
- 14 sites in United States
- Volunteers
- 72 people
- Sponsor
- QuatRx Pharmaceuticals Company
Hypogonadotropic Hypogonadism
A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism
The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with…
- Trial name
- NCT02369796
- Testing
- TAK-448
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Takeda
Hypogonadism
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone levels along with signs and symptoms of androgen deficiency, including delayed development or regression of sexual characteristics, impaired…
- Trial name
- NCT04274894
- Testing
- AndroGel 1.62%
- Where
- 45 sites in United States
- Volunteers
- 246 people
- Sponsor
- AbbVie
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
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.
Male Hypogonadism, Primary Hypogonadism
Pharmacokinetic Study to Determine Time to Steady-state
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
- Conditions
- Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Trial name
- NCT00911586
- Testing
- Testosterone undecanoate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Clarus Therapeutics, Inc.
Male, Hypogonadism
Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice
This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism.
- Trial name
- IPASS Nebido (NCT00410306)
- Testing
- Testosterone Undecanoate (Nebido, BAY86-5037)
- Where
- 33 sites in Australia, Austria and 31 more
- Volunteers
- 1,493 people
- Sponsor
- Bayer
Hypogonadism
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study.
- Trial name
- NCT02777242
- Testing
- Testosterone enanthate auto-injector
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- Antares Pharma 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
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
Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with…
- Conditions
- Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia
- Trial name
- NCT06760546
- Testing
- Setmelanotide
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 39 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.