Clinical trials: Hypogonadism, Male
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
Hypogonadism, Male, Secondary Hypogonadism
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
AIM-TEST is a randomized, double-blind, placebo-controlled clinical trial evaluating whether an AI-guided, microbiome-targeted nutritional intervention can increase the body's own testosterone production in men aged 30-65 years…
- Trial name
- AIM-TEST (NCT07761546)
- Testing
- Fixed-Formula Microbiome-Targeted Oral Nutritional Supplement
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people
- Sponsor
- Varol TUNALI
Male Hypogonadism
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed…
- Trial name
- NCT02966652
- Testing
- DITEST, Testosterone undecanoate
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Neurocrine UK Limited
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, 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
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Halozyme Therapeutics
Hypogonadism, Male
Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men
A Phase 4, multi-center, open-label, single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) study of Testosterone Cypionate Injection in Hypogonadal Men to assess change in 24-hour ambulatory blood pressure from Baseline…
- Trial name
- NCT07328542
- Testing
- Testosterone Cypionate Injection 200 mg/mL
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- Azurity Pharmaceuticals
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
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
Hypogonadism, Male
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
The purpose of this six-month treatment study is to assess feasibility of a lower starting dose of SOV2012-F1 (daily dose of 400 mg [200 mg with breakfast meal and 200mg with dinner meal]) to titrate individual doses to further…
- Trial name
- NCT04467697
- Testing
- SOV2012-F1
- Where
- 19 sites in United States
- Volunteers
- 155 people
- Sponsor
- Marius Pharmaceuticals
Hypogonadism, Male
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month…
- Trial name
- NCT03198728
- Testing
- SOV2012-F1, AndroGel
- Where
- 36 sites in United States
- Volunteers
- 314 people
- Sponsor
- Marius Pharmaceuticals
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.
Hypogonadism, Male
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated…
- Trial name
- NCT03868059
- Testing
- LPCN 1021
- Where
- 16 sites in United States
- Volunteers
- 138 people
- Sponsor
- Lipocine Inc.
Male Hypogonadism, Sexual Dysfunction
D-chiroinositol Administration in Hypogonadal Males
D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis.
- Trial name
- NCT04708249
- Testing
- D-chiroinositol
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Lo.Li.Pharma s.r.l
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
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, 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.
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.
Hypogonadism, Male
Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid…
- Trial name
- NCT03973840
- Testing
- Testosterone Undecanoate
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Clarus Therapeutics, Inc.
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
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.