Prescribing Bioidentical Progesterone Alone for Perimenopausal Women

Evidence for Progesterone-Only Therapy

The American College of Obstetricians and Gynecologists recommends using FDA-approved formulations of micronized progesterone rather than custom-compounded "bioidentical" preparations for perimenopausal women with vasomotor symptoms, due to the lack of standardization, safety data, and efficacy data for custom-compounded products 1

The FDA has not approved any custom-compounded bioidentical hormone therapy for prevention of chronic diseases, and safety/efficacy have not been evaluated through FDA approval processes, highlighting the importance of using FDA-approved micronized progesterone for perimenopausal women 2, 1
Many FDA-approved conventional hormone therapies actually contain bioidentical hormones that are chemically identical to human hormones, making them a safer and more effective option for perimenopausal women 1

The primary indication for progesterone monotherapy is perimenopausal women with bothersome vasomotor symptoms who have contraindications to estrogen therapy, such as a history of hormone-dependent cancers, venous thromboembolism, active or recent stroke/coronary heart disease, or active liver disease 1

Progesterone monotherapy is not indicated for prevention of chronic conditions such as cardiovascular disease, osteoporosis, or dementia, and should only be used for the treatment of vasomotor symptoms in perimenopausal women 1, 4
The lowest effective dose of progesterone should be used for the shortest duration necessary to control symptoms, and patients should be monitored for side effects including vaginal bleeding and headaches 1
Micronized progesterone has lower rates of venous thromboembolism and breast cancer risk compared to synthetic progestins like medroxyprogesterone acetate, making it a safer option for perimenopausal women 1