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Completed

NCT Number: NCT00962637

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. 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.

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Key information

Conditions

Secondary Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year–68 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Additional inclusion and exclusion criteria may apply.

Treatment and study plan

Androxal

Drug

12.5 mg once daily

Other names: Enclomiphene citrate

AndroGel

Drug

5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.

Placebo

Drug

1 capsule daily

Primary outcomes

  1. Evaluate the safety of Androxal™ administered in men with secondary hypogonadism

    Time frame: Six months

Secondary outcomes

  1. Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 20, 2009
Registry last updated
Feb 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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