Hypogonadotropic Drug Effectiveness Guidance

FDA has issued a draft guidance, Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders, with recommendations for establishing clinical effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause structural disorders of the hypothalamus or pituitary gland. The document says the drugs should both increase serum testosterone concentrations and improve how patients feel, function, or survive.

The guidance incorporates advice FDA received at a 12/2014 advisory committee meeting on the appropriate indicated population for testosterone therapy and a 12/2016 advisory committee meeting on hypogonadotropic hypogonadism, the agency says.

Not addressed in the guidance is development of drugs to treat specific conditions associated with male hypogonadotropic hypogonadism such as weight management in obese patients.