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

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00962637
First received: August 18, 2009
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Secondary Hypogonadism
Drug: Androxal
Drug: AndroGel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Evaluate the safety of Androxal™ administered in men with secondary hypogonadism [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: March 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Androxal™ 12.5 mg
Drug: Androxal
12.5 mg once daily
Other Name: Enclomiphene citrate
Experimental: 2
Androxal™ 25 mg
Drug: Androxal
25 mg once daily
Other Name: 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.
Placebo Comparator: 4
Placebo
Drug: Placebo
1 capsule daily
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962637

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

No publications provided

Responsible Party: Andre van As, MD, PhD, Repros Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00962637     History of Changes
Other Study ID Numbers: ZA-003
Study First Received: August 18, 2009
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Secondary Hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone
Testosterone enanthate
Testosterone undecanoate
Enclomiphene
Clomiphene
Zuclomiphene
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on August 26, 2014