HRT clinical evaluation guidance

Executive Summary

Sponsors of estrogen/progestin combination clinical trials should "identify the lowest effective dose" of estrogen and progestin to support an indication for moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, FDA draft guidance says. The guidance, "Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms - Recommendations for Clinical Evaluation," notes that the hormone combination may be associated with an increased risk of breast cancer and cardiovascular events. The "lowest effective dose" recommendation comes although "specific relationships between dose, exposure, and the risk of adverse events may not be known." The draft guidance would replace 1995 recommendations that FDA withdrew following publication of WHI study results (1"The Pink Sheet" July 15, 2002, p. 11)...