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

Last updated: February 10, 2010
Sponsor: Repros Therapeutics Inc.
Overall Status: Completed

Phase

3

Condition

Neoplasm Metastasis

Hypogonadism

Treatment

N/A

Clinical Study ID

NCT00962637
ZA-003
  • Ages 18-68
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Presence or history of prostate cancer

  • Elevated PSA > 3.5 ng/mL Additional inclusion and exclusion criteria may apply.

Study Design

Total Participants: 194
Study Start date:
March 01, 2006
Estimated Completion Date:
May 31, 2007

Connect with a study center

  • Alabama Clinical Therapeutics, LLC

    Birmingham,, Alabama 35235
    United States

    Site Not Available

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Northern California Research Corp.

    Carmichael, California 95608
    United States

    Site Not Available

  • Prime-Care Clinical Research

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Southeastern Research Group, Inc.

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Northeast Indiana Research, LLC

    Fort Wayne, Indiana 46825
    United States

    Site Not Available

  • Commonwealth Biomedical Research

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • The Center for Sexual Medicine at Sheppard Pratt

    Baltimore, Maryland 21285
    United States

    Site Not Available

  • Office of Keith Pierce, MD

    Livonia, Michigan 48152
    United States

    Site Not Available

  • Office of Michael Mall, MD

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Office of Stephen Miller, MD

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Advanced Biomedical Research, Inc.

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Office of Gary S. Karlin

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Medial Research Associates of Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Urology San Antonio Research, PA

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Salt Lake Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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