Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
NCT ID: NCT00962637
Last Updated: 2010-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
194 participants
INTERVENTIONAL
2006-03-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Androxal™ 12.5 mg
Androxal
12.5 mg once daily
2
Androxal™ 25 mg
Androxal
25 mg once daily
3
AndroGel®
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.
4
Placebo
Placebo
1 capsule daily
Interventions
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Androxal
12.5 mg once daily
Androxal
25 mg once daily
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
1 capsule daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Elevated PSA \> 3.5 ng/mL
18 Years
68 Years
MALE
No
Sponsors
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Repros Therapeutics Inc.
INDUSTRY
Responsible Party
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Repros Therapeutics, Inc.
Principal Investigators
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Andre van As, MD, PhD
Role: STUDY_DIRECTOR
Repros Therapeutics Inc.
Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Northern California Research Corp.
Carmichael, California, United States
Prime-Care Clinical Research
Mission Viejo, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Southeastern Research Group, Inc.
Tallahassee, Florida, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, United States
The Center for Sexual Medicine at Sheppard Pratt
Baltimore, Maryland, United States
Office of Keith Pierce, MD
Livonia, Michigan, United States
Office of Michael Mall, MD
Las Vegas, Nevada, United States
Office of Stephen Miller, MD
Las Vegas, Nevada, United States
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, United States
Office of Gary S. Karlin
Lawrenceville, New Jersey, United States
Medial Research Associates of Nashville
Nashville, Tennessee, United States
Urology San Antonio Research, PA
San Antonio, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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ZA-003
Identifier Type: -
Identifier Source: org_study_id
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