Secondary Hypogonadism Clinical Trial
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
The purpose of ZA-301 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.
Protocol ZA-301 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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