Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 10/3/2025

Menopausal Symptom Management with Hormone Therapy

Introduction to Hormone Therapy

  • The USPSTF identified no randomized trials studying the potential benefits or harms of bioidentical hormones for menopausal women, and the FDA has not approved any type or class of bioidentical hormone therapy 1, 2
  • Custom compounded bioidentical hormones are not recommended because data supporting claims that they are safer and more effective than standard hormones are lacking, according to the Journal of the National Comprehensive Cancer Network 3

FDA-Approved Oral Hormone Therapy

  • The Women's Health Initiative studied oral conjugated equine estrogen 0.625 mg/day, providing the most robust safety and efficacy data available, as reported by the Annals of Internal Medicine 4, 5
  • The American College of Physicians recommends using the lowest effective dose of FDA-approved oral conjugated estrogens or estradiol for menopausal symptoms, as stated in the Annals of Internal Medicine 4, 6

Safety Profile of FDA-Approved Oral Hormones

  • Combined estrogen-progestin therapy increases risk for stroke, invasive breast cancer, dementia, gallbladder disease, DVT, and pulmonary embolism, with an absolute excess risk of events in the "global index" of 19 per 10,000 women-years, according to the Annals of Internal Medicine 4
  • Estrogen-alone therapy is associated with reduction in fractures (56 prevented per 10,000 person-years) and small reduction in invasive breast cancer risk (8 fewer cases per 10,000 person-years), as reported by the Annals of Internal Medicine 4, 5

Clinical Decision Algorithm

  • For women with menopausal symptoms, the first-line treatment should be FDA-approved oral conjugated estrogens or estradiol at the lowest effective dose, as recommended by the Annals of Internal Medicine and the Journal of the National Comprehensive Cancer Network 1, 2, 3, 6
  • Women with intact uterus require progestin (micronized progesterone preferred over medroxyprogesterone acetate due to lower VTE and breast cancer risk), according to the Journal of the National Comprehensive Cancer Network and the Praxis Medical Insights 3, 6