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

February 10, 2010 updated by: Repros Therapeutics Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

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
        • Medical 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
        • Commonwealth 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
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Medial 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

14 years to 64 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Placebo
Drug: Placebo
1 capsule daily
Experimental: 1
Androxal™ 12.5 mg
Drug: Androxal
12.5 mg once daily
Other Names:
  • Enclomiphene citrate
Drug: Androxal
25 mg once daily
Other Names:
  • Enclomiphene citrate
Experimental: 2
Androxal™ 25 mg
Drug: Androxal
12.5 mg once daily
Other Names:
  • Enclomiphene citrate
Drug: Androxal
25 mg once daily
Other Names:
  • Enclomiphene citrate
Active Comparator: 3
AndroGel®
Drug: 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.

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: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
Time Frame: Six months
Six months

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

August 18, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimate)

August 20, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2010

Last Update Submitted That Met QC Criteria

February 10, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZA-003

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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