Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism (ZA-003Ext)

June 26, 2014 updated by: Repros Therapeutics Inc.

An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham,, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC
      • Huntsville, Alabama, United States, 35801
        • Medial Affiliated Research Center, Inc.
    • California
      • Carmichael, California, United States, 95608
        • Northern California Research Corp
      • Mission Viejo, California, United States, 92691
        • Prime-Care Clinical Research
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Tallahassee,, Florida, United States, 32308
        • Southeastern Research Group, Inc.
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Northeast Indiana Research, LLC
    • Kentucky
      • Madisonville,, Kentucky, United States, 42431
        • Commonweatlh Biomedical Research
    • Maryland
      • Baltimore, Maryland, United States, 21285
        • The Center for Sexual Medicine at Sheppard Pratt
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Office of Keith Pierce, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Office of Michael Mall, MD
      • Las Vegas, Nevada, United States, 89144
        • Office of Stephen Miller, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Advanced Biomedical Research, Inc.
      • Lawrenceville, New Jersey, United States, 08648
        • Office of Gary S. Karlin, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Medical Research Associates of Nashville
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research, PA
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12.5 mg Androxal
12.5 mg Androxal daily
Drug: Androxal
12.5 mg once daily
Other Names:
  • Enclomiphene citrate
Drug: Androxal
25 mg once daily
Other Names:
  • Enclomiphene citrate
Experimental: 25 mg Androxal
25 mg Androxal daily
Drug: Androxal
12.5 mg once daily
Other Names:
  • Enclomiphene citrate
Drug: Androxal
25 mg once daily
Other Names:
  • Enclomiphene citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Investigators

  • Study Director: Andre van As, MD, PhD, Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (Estimate)

February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZA-003 Extension Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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