An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
|ClinicalTrials.gov Identifier: NCT01739582|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : April 16, 2014
Repros Therapeutics Inc.
Information provided by (Responsible Party):
Repros Therapeutics Inc.
To determine the safety profile of Androxal in men with secondary hypogonadism.
|Condition or disease||Intervention/treatment||Phase|
|Secondary Hypogonadism||Drug: Androxal||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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
Primary Outcome Measures :
- Testosterone levels [ Time Frame: 26 weeks ]Values of total morning testosterone levels at each visit
Secondary Outcome Measures :
- Follicle Stimulating Hormone and Leutinizing Hormone [ Time Frame: 26 weeks ]Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit
- Diabetic Parameters [ Time Frame: 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) [ Time Frame: 26 weeks ]Change in weight and BMI
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