An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

NCT ID: NCT01739582

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-04-30

Brief Summary

To determine the safety profile of Androxal in men with secondary hypogonadism.

Detailed Description

This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Conditions

Secondary Hypogonadism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Androxal

Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2.

Group Type: EXPERIMENTAL

Androxal

Intervention Type: DRUG

Interventions

Androxal

Intervention Type: DRUG

Other Intervention Names

enclomiphene citrate

Eligibility Criteria

Inclusion Criteria

• Successful completion of either ZA-301 or ZA-302

Exclusion Criteria

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Repros Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZA-301EXT

Identifier Type: -

Identifier Source: org_study_id