An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
To determine the safety profile of Androxal in men with secondary hypogonadism.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism|
- Testosterone levels [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Values of total morning testosterone levels at each visit
- Follicle Stimulating Hormone and Leutinizing Hormone [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit
- Diabetic Parameters [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in weight and BMI
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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.
Other Name: enclomiphene citrate
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.