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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067365
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : June 27, 2014
Information provided by (Responsible Party):
Repros Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Secondary Hypogonadism Drug: Androxal Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Evaluate the safety of Androxal™ administered in men with secondary hypogonadism [ Time Frame: One year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067365

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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 Michael Mall, MD
Las Vegas, Nevada, United States, 89109
Office of Stephen Miller, MD
Las Vegas, Nevada, United States, 89144
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.
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Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.

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Responsible Party: Repros Therapeutics Inc. Identifier: NCT01067365     History of Changes
Other Study ID Numbers: ZA-003 Extension Study
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014
Keywords provided by Repros Therapeutics Inc.:
Secondary Hypogonadism
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators