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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01067365
First received: February 10, 2010
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Secondary Hypogonadism
Drug: Androxal
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

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: One year ] [ Designated as safety issue: Yes ]

Enrollment: 104
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: 12.5 mg Androxal
12.5 mg Androxal daily
Drug: Androxal
12.5 mg once daily
Other Name: Enclomiphene citrate
Experimental: 25 mg Androxal
25 mg Androxal daily
Drug: Androxal
25 mg once daily
Other Name: Enclomiphene citrate

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.

  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: NCT01067365

Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham,, Alabama, United States, 35235
Medial 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
Commonweatlh 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, MD
Lawrenceville, New Jersey, United States, 08648
United States, Tennessee
Medical 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: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01067365     History of Changes
Other Study ID Numbers: ZA-003 Extension Study
Study First Received: February 10, 2010
Last Updated: June 26, 2014
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
Clomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on July 29, 2014