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

Repros Therapeutics

Status and phase: Completed; Phase 3

Conditions: Secondary Hypogonadism

Treatments: Drug: AndroGel; Drug: Androxal; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962637

ZA-003

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: Male

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Androxal™ 12.5 mg

Treatment:

Drug: Androxal

Drug: Androxal

2

Experimental group

Description:

Androxal™ 25 mg

Treatment:

Drug: Androxal

Drug: Androxal

3

Active Comparator group

Description:

AndroGel®

Treatment:

Drug: AndroGel

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo