Clinical trials: Testosterone
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
Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™
Multicenter study consisting of two study periods as follows: a 90-day Treatment Period, with potential extension by 30 days for those patients requiring a dose increase, as determined by the treating physician.
- Trial name
- MyT (NCT02937740)
- Testing
- NATESTO Testosterone Nasal Gel
- Where
- 11 sites in Canada
- Volunteers
- 117 people
- Sponsor
- Acerus Pharmaceuticals Corporation
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
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
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.
Adult Male Hypogonadism
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
- Trial name
- NCT02149264
- Testing
- Testosterone gel (FE 999303)
- Where
- 22 sites in United States
- Volunteers
- 160 people
- Sponsor
- Ferring Pharmaceuticals
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
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, 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
Female Sexual Dysfunction
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
The purpose of this study was to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2.
- Trial name
- NCT01364623
- Testing
- Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose, High dose testosterone nasal gel, single dose
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Acerus Pharmaceuticals Corporation
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
Secondary Hypogonadism
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.
- Trial name
- NCT01386606
- Testing
- Androxal (enclomiphene citrate), Testosterone
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Repros Therapeutics Inc.
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
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
Hypogonadotropic Hypogonadism
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks.
- Trial name
- NCT02730169
- Testing
- BGS649
- Where
- 63 sites in United States, Italy and 2 more
- Volunteers
- 271 people
- Sponsor
- Mereo BioPharma
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
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
- Trial name
- NCT01104246
- Testing
- Testerone Transdermal System
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Watson Pharmaceuticals
Hypogonadism
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
- Trial name
- NCT02504541
- Testing
- Testosterone enanthate auto-injector
- Where
- 20 sites in United States
- Volunteers
- 133 people
- Sponsor
- Antares Pharma Inc.
Female Orgasmic Disorder
Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.
- Trial name
- NCT01607658
- Testing
- Low dose TBS-2, Medium dose TBS-2, High dose TBS-2
- Where
- 53 sites in United States, Australia and 1 more
- Volunteers
- 253 people
- Sponsor
- Acerus Pharmaceuticals Corporation
Hypogonadism
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
Evaluation of pharmacokinetics of subcutaneous testosterone enanthate
- Trial name
- NCT02233751
- Testing
- Testosterone enanthate auto-injector
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Antares Pharma Inc.