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

Phase 3

Completed

• Conditions: Secondary Hypogonadism
• Interventions: Drug: Androxal

• Registration Number: NCT01739582
• Lead Sponsor: Repros Therapeutics Inc.

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-03
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-15
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Androxal	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.

Primary Outcome Measures

Name	Time	Method
Testosterone levels	26 weeks	Values of total morning testosterone levels at each visit

Secondary Outcome Measures

Name	Time	Method
Follicle Stimulating Hormone and Leutinizing Hormone	26 weeks	Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit
Diabetic Parameters	26 weeks	Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes
Change in weight and body mass index (BMI)	26 weeks	Change in weight and BMI