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Brief Title: Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism
Official Title: A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration
Study ID: NCT01739595
Brief Summary: The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.
Detailed Description: Protocol ZA-302 is a randomized, double-blind, placebo-controlled multi-center Phase 3 study to evaluate normalization of morning testosterone levels in overweight men with acquired hypogonadotropic hypogonadism and normal baseline sperm concentrations. The study requires 10 to 12 clinic visits (2 for eye exams), and is approximately 4 to 5½ months in duration. Subjects will be treated for 12-18 weeks. At Visit 3 (Week 6) subjects who do not achieve morning T values ≥300 ng/dL will be up-titrated to 25 mg. Placebo subjects may be sham titrated. Up-titrated subjects will receive an additional 6 weeks of treatment (18 weeks total). A schedule of procedures and assessments is displayed in Section 4. The study will enroll up to 152 male subjects, up to 114 randomized to treatment with Androxal and up to 38 randomized to placebo, in a 3:1 ratio. Subjects must not have used any prior testosterone treatments within the last 6 months. Eligible subjects must have 2 consecutive assessments of morning T below 300 ng/dL and LH below 9.4 mIU/mL. They will provide 2 sperm samples at baseline, at least 2 days apart, another 2 after 12 weeks of treatment, and up-titrated subjects will provide an additional 2 samples at the end of treatment. After 12 weeks of treatment (V5) all subjects will undergo serial T assessment for determination of the Cavg. Safety assessments will include collection of adverse events, eye examinations, physical examinations and clinical laboratory assessments.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: MALE
Healthy Volunteers: No
Coastal Clinical Research, Mobile, Alabama, United States
Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States
Rancho Cucamonga Clinical Trials, Rancho Cucamonga, California, United States
Meridien Research, Bradenton, Florida, United States
All Medical Research, Cooper City, Florida, United States
Clinical Research of South Florida, Coral Gables, Florida, United States
Phase One Solutions, Miami Gardens, Florida, United States
Central Kentucky Research Associates, Lexington, Kentucky, United States
Rochester Clinical Research, Rochester, New York, United States
Coastal Carolina Research Center, Mount Pleasant, South Carolina, United States
New Orleans Center for Clinical Research, Knoxville, Texas, United States
Lone Peak Family Medicine, Draper, Utah, United States
Granger Medical Clinic, Riverton, Utah, United States
Name: Joseph S Podolski
Affiliation: Repros Therapeutics Inc.
Role: STUDY_CHAIR