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NCT00962637 Clinical Trial

Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Secondary Hypogonadism Clinical Trial

Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00962637
Other study ID # ZA-003
Secondary ID
Status Completed
Phase Phase 3
First received August 18, 2009
Last updated February 10, 2010
Start date March 2006
Est. completion date May 2007

Study information
Verified date February 2010
Source Repros Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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 hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

Recruitment information / eligibility
Status Completed
Enrollment 194
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 68 Years
Eligibility Inclusion Criteria:

- Total serum testosterone concentrations < 300 ng/dL at baseline

Exclusion Criteria:

- Presence or history of prostate cancer

- Elevated PSA > 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Androxal
12.5 mg once daily
• Androxal
25 mg once daily
• AndroGel
5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.
• Placebo
1 capsule daily

Locations
Country Name City State
United States The Center for Sexual Medicine at Sheppard Pratt Baltimore Maryland
United States Alabama Clinical Therapeutics, LLC Birmingham, Alabama
United States Northern California Research Corp. Carmichael California
United States Northeast Indiana Research, LLC Fort Wayne Indiana
United States Advanced Biomedical Research, Inc. Hackensack New Jersey
United States Medical Affiliated Research Center, Inc. Huntsville Alabama
United States Office of Michael Mall, MD Las Vegas Nevada
United States Office of Stephen Miller, MD Las Vegas Nevada
United States Office of Gary S. Karlin Lawrenceville New Jersey
United States Office of Keith Pierce, MD Livonia Michigan
United States Commonwealth Biomedical Research Madisonville Kentucky
United States Prime-Care Clinical Research Mission Viejo California
United States Medial Research Associates of Nashville Nashville Tennessee
United States Salt Lake Research Salt Lake City Utah
United States Urology San Antonio Research, PA San Antonio Texas
United States Southeastern Research Group, Inc. Tallahassee Florida
United States Harbor-UCLA Medical Center Torrance California
United States Chase Medical Research, LLC Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the safety of Androxal™ administered in men with secondary hypogonadism Six months Yes
Secondary Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® Six months No
See also
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Completed NCT01191320 - Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus Phase 2
Completed NCT01739595 - Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism Phase 3
Completed NCT01739582 - An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Phase 3
Active, not recruiting NCT02443090 - Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men Phase 2
Completed NCT01534208 - Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Phase 3
Completed NCT00467870 - Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men Phase 3
Completed NCT01067365 - Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism Phase 3
Completed NCT01386606 - The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) Phase 2
Completed NCT00706719 - To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone Phase 2
Completed NCT00911586 - Pharmacokinetic Study to Determine Time to Steady-state Phase 2
Completed NCT01993225 - A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% Phase 3
Completed NCT01993212 - A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% Phase 3
Completed NCT01270841 - Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism Phase 2
Completed NCT02274181 - 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 Phase 1
Completed NCT01923857 - Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function Phase 1
Completed NCT01923870 - Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function Phase 1
Completed NCT01532414 - Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism Phase 3