Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Public ClinicalTrials.gov record NCT00962637. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00962637
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 194 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 68 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2006 (Type not available)
- Primary completion
- May 2007 (Actual)
- Completion
- May 2007 (Actual)
- Last update posted
- Feb 11, 2010
2006 – 2007
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| Medical Affiliated Research Center, Inc. | Huntsville | Alabama | 35801 | — |
| Northern California Research Corp. | Carmichael | California | 95608 | — |
| Prime-Care Clinical Research | Mission Viejo | California | 92691 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | — |
| Southeastern Research Group, Inc. | Tallahassee | Florida | 32308 | — |
| Northeast Indiana Research, LLC | Fort Wayne | Indiana | 46825 | — |
| Commonwealth Biomedical Research | Madisonville | Kentucky | 42431 | — |
| The Center for Sexual Medicine at Sheppard Pratt | Baltimore | Maryland | 21285 | — |
| Office of Keith Pierce, MD | Livonia | Michigan | 48152 | — |
| Office of Michael Mall, MD | Las Vegas | Nevada | 89109 | — |
| Office of Stephen Miller, MD | Las Vegas | Nevada | 89144 | — |
| Advanced Biomedical Research, Inc. | Hackensack | New Jersey | 07601 | — |
| Office of Gary S. Karlin | Lawrenceville | New Jersey | 08648 | — |
| Medial Research Associates of Nashville | Nashville | Tennessee | 37203 | — |
| Urology San Antonio Research, PA | San Antonio | Texas | 78229 | — |
| Salt Lake Research | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00962637, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 11, 2010 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00962637 live on ClinicalTrials.gov.