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

Last updated: June 26, 2014
Sponsor: Repros Therapeutics Inc.
Overall Status: Completed

Phase

3

Condition

Neoplasm Metastasis

Hypogonadism

Treatment

N/A

Clinical Study ID

NCT01067365
ZA-003 Extension Study
  • Ages 18-68
  • Male

Study Summary

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

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: 104
Study Start date:
March 01, 2006
Estimated Completion Date:
May 31, 2007

Study Description

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Connect with a study center

  • Alabama Clinical Therapeutics, LLC

    Birmingham,, Alabama 35235
    United States

    Site Not Available

  • Medial 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

  • Commonweatlh 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, MD

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Medical 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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