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Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
NCT00962637 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00962637 reports 18 study locations spanning 13 distinct geographic areas — top geographies include California, Alabama, Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00962637?
The interventions under investigation include: Placebo (DRUG), Androxal (DRUG), AndroGel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00962637?
This trial is sponsored by Repros Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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