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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: Completed Phase 3 study of Secondary Hypogonadism, sponsored by Repros Therapeutics.

NCT00962637 is a Phase 3 study of Secondary Hypogonadism that has completed, run by Repros Therapeutics. The registered enrollment target is 194 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 194 participants
Start Date 2006-03
Est. Completion 2007-05
Phase Phase 3
Repros Therapeutics

50 total trials

What the finished NCT00962637 record still lists

NCT00962637 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).

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 lists 18 locations in 13 states (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.

Similar trials for Secondary Hypogonadism

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00962637's enrollment target sits among peer trials

194 1395th of 2000 higher than 604 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00962637, the US trial registry maintained by the National Library of Medicine. NCT00962637 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.