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Citrate

Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

Placebo oral capsules taken one time daily

oral, capsules, taken one time daily, for 3 months

enclomiphene citrate

Oral capsule taken one time daily for 3 months

Placebo

Joseph S Podolski

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.

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.

Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

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

Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.

If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved.

FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated.

Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.

The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations.

Repros Therapeutics Inc.

Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Androxal 12.5 mg

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Androxal 25 mg

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Jennifer Wike

Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism	NCT01739595	Secondary Hypog...	enclomiphene ci... Placebo	18 Years - 60 Years	Repros Therapeutics Inc.
Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism	NCT01739595	Secondary Hypog...	enclomiphene ci... Placebo	18 Years - 60 Years	Repros Therapeutics Inc.

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