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

Completed · Phase 3 · Has a placebo group

Conditions studied: Secondary Hypogonadism

In brief

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.

Key facts

Study ID

NCT00962637

Run by

Repros Therapeutics Inc.

People needed

194

Starts

2006-03-01

Expected to finish

2007-05-01

Last updated by the study team

2010-02-11

Who can join

Age: 18 and older, up to 68. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Presence or history of prostate cancer
• Elevated PSA > 3.5 ng/mL
• Additional inclusion and exclusion criteria may apply.

Where it is running

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

Full record on ClinicalTrials.gov

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