Evidence on the use of progesterone in menopausal hormone therapy.

A need exists for a regulatory agency-approved hormone therapy (HT) with naturally occurring hormones combining progesterone (P4) and estradiol (E2), since no single product contains both endogenous hormones. Many women choose HT with P4 and millions of women around the world are using unapproved, poorly regulated compounded HT. The use of natural P4 in HT results, for the most part, in favorable outcomes without deleterious effects, as shown in clinical studies of postmenopausal women. Importantly, P4 used in HT prevents endometrial hyperplasia from estrogens while helping relieve vasomotor symptoms and improving quality-of-life measures. Additionally, risk of venous thromboembolism and breast cancer does not appear to increase with use of P4 plus estrogens as shown with synthetic progestins plus estrogens in large observations studies, and no detrimental effects of P4 in HT have been found on outcomes related to cardiovascular disease or cognition. A regulatory agency-approved HT with naturally occurring E2/P4 could be an option for the millions of women who desire a bioidentical product and/or are exposed to potential risks of inadequately studied and under-regulated compounded HT.