Secondary Hypogonadism
Conditions
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.
Interventions
DRUGAndroxal
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Testosterone levels | 26 weeks | Values of total morning testosterone levels at each visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed