Study ZA-302 (Pivotal Efficacy Study)For study ZA-302, results were almost identical to the previously reported study ZA-301. Both co-primary endpoints were met in each of the Androxal pivotal efficacy studies with respect to T normalization and sperm function conducted under a Special Protocol Assessment (SPA). Under an SPA, efficacy endpoints are predetermined with the FDA and if the endpoints are met the efficacy component of the drug dossier is deemed successfully completed.
Repros Reports Preliminary Findings: Second Pivotal Study And 6-Month Safety Study Support Androxal(R) Approvability
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