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NCT00962637 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
A Phase 3 study of Secondary Hypogonadism, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
- 18
- Study locations
NCT00962637 is a Phase 3 study of Secondary Hypogonadism that has completed, run by Repros Therapeutics. The registered enrollment target is 194 participants. The trial reports 18 study locations across 13 states.
The verdict
NCT00962637, a Phase 3 study of Secondary Hypogonadism, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Androxal
- DRUG AndroGel
Study Locations (18)
California
- Northern California Research Corp. - Carmichael
- Prime-Care Clinical Research - Mission Viejo
- Harbor-UCLA Medical Center - Torrance
Alabama
- Alabama Clinical Therapeutics, LLC - Birmingham
- Medical Affiliated Research Center, Inc. - Huntsville
Nevada
- Office of Michael Mall, MD - Las Vegas
- Office of Stephen Miller, MD - Las Vegas
New Jersey
- Advanced Biomedical Research, Inc. - Hackensack
- Office of Gary S. Karlin - Lawrenceville
Connecticut
- Chase Medical Research, LLC - Waterbury
Florida
- Southeastern Research Group, Inc. - Tallahassee
Indiana
- Northeast Indiana Research, LLC - Fort Wayne
Kentucky
- Commonwealth Biomedical Research - Madisonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00962637
The ClinicalTrials.gov registry entry for NCT00962637 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Secondary Hypogonadism appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00962637 reports 18 study locations spanning 13 distinct geographic areas - top geographies include California, Alabama, Nevada.
Frequently Asked Questions
What is clinical trial NCT00962637 about?
NCT00962637 is a clinical study titled "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. Appr...
What is the current status of trial NCT00962637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2006-03. Estimated completion is 2007-05.
What conditions does trial NCT00962637 study?
This clinical trial studies the following conditions: Secondary Hypogonadism.
What interventions are being tested in trial NCT00962637?
The interventions under investigation include: Placebo (DRUG), Androxal (DRUG), AndroGel (DRUG).
Who is sponsoring clinical trial NCT00962637?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00962637 being conducted?
This trial has 18 study locations across Alabama, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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