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COMPLETEDPhase 3NCT00962637

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 i...

Lead sponsor: Repros Therapeutics Inc.•18 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Repros Therapeutics Inc.

Age

18 - 68 years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Total serum testosterone concentrations \< 300 ng/dL at baseline

Exclusion Criteria

•Presence or history of prostate cancer
•Elevated PSA \> 3.5 ng/mL

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COMPLETEDPhase 3

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

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COMPLETEDPhase 2

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 11, 2010Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment194

Start dateMar 2006

Last updatedFeb 11, 2010

Condition

Secondary Hypogonadism

Locations shown

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama

Medical Affiliated Research Center, Inc.

Huntsville, Alabama

Northern California Research Corp.

Carmichael, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2010Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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