Clinical trials: Hypogonadism
Hypogonadism
A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
- Trial name
- inTUne (NCT02722278)
- Testing
- Oral Testosterone Undecanoate, Axiron Testosterone Topical Solution
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Clarus Therapeutics, Inc.
Male Hypogonadism
Time to Eugonadal Range, Time to Steady State and Drying Time
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and…
- Trial name
- NCT01228071
- Testing
- testosterone gel 2%
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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
Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18)
Non-Invasive Determination of Fetal Chromosome Abnormalities
The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome…
- Conditions
- Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Klinefelter Syndrome (47, XXY)
- Trial name
- NCT00891852
- Where
- 7 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Lenetix Medical Screening Laboratory
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
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.
Hypogonadism
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors.
- Trial name
- NCT00522431
- Testing
- Testosterone
- Volunteers
- 149 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Hypogonadism, Cardiovascular Diseases
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.
- Trial name
- TRAVERSE (NCT03518034)
- Testing
- AndroGel®
- Where
- 384 sites in United States, Puerto Rico
- Volunteers
- 5,246 people
- Sponsor
- AbbVie
Type 2 Diabetes, Hypogonadism
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral…
- Trial name
- NCT00141492
- Testing
- Androgel (testosterone gel)
- Where
- 70 sites in United States
- Sponsor
- Solvay Pharmaceuticals
Hypogonadism, Low Testosterone
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203.
- Trial name
- NCT01386567
- Testing
- Androxal (enclomiphene citrate), Testim (topical testosterone)
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism
Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.
- Trial name
- NCT02697188
- Testing
- Testosterone undecanoate, Testosterone enanthate
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadism
Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.
- Trial name
- NCT00220298
- Testing
- Testosterone undecanoate (TU) - NebidoTM
- Where
- 14 sites in Germany
- Volunteers
- 96 people
- Sponsor
- Bayer
Hypogonadotropism
A Dose Ranging Study to Examine TDS-Testosterone 5%
This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with…
- Trial name
- PARC-T-D (NCT01894308)
- Testing
- Testosterone, Pump Sprayer
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Transdermal Delivery Solutions Corp
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.
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.
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
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
Hypogonadism
Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal…
- Trial name
- NCT01786473
- Testing
- Testogel 1%
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Laboratoires Besins International
Secondary Hypogonadism
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.
- Trial name
- ZA-003Ext (NCT01067365)
- Testing
- Androxal
- Where
- 18 sites in United States
- Volunteers
- 104 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a…
- Trial name
- NCT01172366
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Acrux DDS Pty Ltd