Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders; Draft Guidance for Industry; Availability

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders." This draft guidance provides key design considerations, including recommendations for patient enrollment criteria and efficacy endpoints, for clinical trials to establish effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause intrinsic damage to the hypothalamus or pituitary gland. This draft guidance is consistent with recommendations FDA received at the December 2014 advisory committee meeting on the appropriate indicated population for testosterone replacement therapy, and the December 2016 advisory committee meeting on hypogonadotropic hypogonadism.