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

Repros Therapeutics Inc.104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Secondary Hypogonadism

Interventions

AndroxalDRUG

12.5 mg once daily

AndroxalDRUG

25 mg once daily

Eligibility

Sex: MALEMin age: 18 YearsMax age: 68 Years

Medical Language ↔ Plain English

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.

Locations (18)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Medial Affiliated Research Center, Inc.

Huntsville, Alabama, United States

Outcomes

Primary Outcomes

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

Time frame: One year

Data from ClinicalTrials.gov

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