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FDA advisory panel to discuss trial design, endpoints for secondary hypogonadism
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An FDA advisory committee will meet Tuesday to discuss appropriate clinical trial design for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis.
Members of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will not discuss the benefit–risk assessment of a particular drug or the safety profiles of individual drugs or classes of drugs, according to a description of the meeting on the FDA website. Instead, the meeting will focus on trial design features, including acceptable endpoints for demonstrating clinical benefit.
Advisory committee members will consider several draft points relating to trial design for drugs intended to treat secondary hypogonadism while either preserving or improving testicular function, according to FDA briefing documents released in advance of the meeting. Discussion points include the patient population that should be enrolled, how preservation of testicular function should be defined and assessed, and acceptable endpoints for demonstrating clinical benefit in men with classic hypogonadism.
Other discussion questions include the following:
For products intended to treat men with hypogonadism attributed to obesity, is raising serum testosterone concentrations into the normal range for young, healthy eugonadal men and preservation of spermatogenesis, as assessed by maintenance of sperm concentrations, sufficient for establishing evidence of clinical benefit?
For products intended to treat men with classic secondary hypogonadism and azoospermia or oligospermia, is raising sperm concentration above a specific threshold sufficient evidence of clinical benefit?
For products intended to treat men with secondary hypogonadism and azoospermia or oligospermia, but who do not have classic hypogonadism, is raising sperm concentration above a specific threshold sufficient evidence of clinical benefit?
The meeting will include presentations addressing the effects of secondary hypogonadism on testicular function and an open public hearing, followed by committee deliberation, discussion and voting. – by Regina Schaffer