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Completed

NCT Number: NCT01067365

Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

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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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About this study

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

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

Primary outcomes

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

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Official study title

An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

Acronym: ZA-003Ext

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 11, 2010
Registry last updated
Jun 27, 2014

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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