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|
|Study Completion Date:||April 2014|
|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.
No Contacts or Locations Provided