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FDA Approved Indications for MHT

Who: Healthy women who are within 10 years of menopause OR younger than 60 and do not have contraindications


• Vasomotor Symptoms: First-line therapy for appropriate candidates

• Vulvovaginal Atrophy (VVA) / GSM: shown to effectively restore GU tract anatomy, increase superficial vaginal cells, reduce vaginal pH, and treat symptoms of VVA

• Prevention of Bone Loss: RCTs show MHT prevent bone loss and reduce fractures in postmenopausal women

• Premature hypoestrogenism: approved for women with hypogonadism, POI, premature iatrogenic menopause without contraindications

Initiating Systemic MHT for Vasomotor Symptoms

Step 1: Is patient aged 50-59 or within 10 years of menopause with moderate to severe VMS?

Step 2: Assess Contraindications: Hx estrogen-sensitive breast or endometrial cancer, CHD, Previous VTE or inherited high-risk thrombophilia, Previous stroke or TIA, Active liver disease (severe), Unexplained vaginal bleeding, Porphyria cutanea tarda, Hypertriglyceridemia Relative contraindications: endometriosis, leiomyomas, migraines (all may worsen on hormone therapy)

Step 3: Assess patient’s baseline risk Cardiovascular —> 10 year ASCVD Breast —> Gail Model

Step 4: Use lowest dose estrogen necessary to relieve symptoms

Step 5: Uterus? Add systemic progesterone

Step 6: Assess for side effects of therapy, adjust dose as needed lower dose = fewer side effects yearly mammography vaginal bleeding requires endometrial biopsy

Step 7: Reassess symptoms and risk score annually

Step 8: Discontinue Recommend ≤ 5 years therapy, not beyond age 60 Taper slowly to reduce symptom recurrence


• Davis S, Lambrinoudaki I, Lumsden M. et al. Menopause. Nat Rev Dis Primers 1, 15004 (2015). https://doi.org/ 10.1038/nrdp.2015.4

• Monteleone P, Mascagni G., Giannini A. et al. Symptoms of menopause — global prevalence, physiology and implications. Nat Rev Endocrinol 14, 199–215 (2018). https://doi.org/10.1038/nrendo.2017.180

• American College of Obstetricians and Gynecologists. Management of Menopause Symptoms. ACOG Practice Bulletin No. 141. Obstet Gynecol 2014;123(1):202- 211

• ShifrenJ, Gass, M for NAMS Recommendations for Clinical Care of Midlife Women Working Group. The North American Menopause Society Recommendations for Clinical Care of Midlife Women. Menopause: The Journal of The North American Menopause Society. Vol. 21, No. 10, pp. 1-25.

• Black, D. The Safety of Oral Versus Transdermal Estrogen. Menopause: The Journal of The North American Menopause Society Vol. 27, No. 11, pp. 1328-1329

• Rossouw JE, Anderson GL, et al. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial, JAMA. 2002;288(3):321

• Anderson GL, Limacher M, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women’s Health Initiative randomized controlled trial. Women’s Health Initiative Steering Committee SO JAMA. 2004;291(14):1701

• Manson JE, Chlebowski RT, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. JAMA. 2013 Oct;310(13):1353-68.

• Rossouw JE, Manson JE, Kaunitz AM, Anderson GL. Lessons learned from the Women’s Health Initiative trials of menopausal hormone therapy. Obstet Gynecol. 2013;121(1):172.

• Jaya M. Mehta, Rebecca C. Chester, and Juliana M. Kling. The timing hypothesis: Hormone therapy for treating symptomatic women during menopause and its relationship to cardiovascular disease. Journal of Women’s Health.May 2019.705-711.http://doi.org/10.1089/jwh.2018.7201

• Mariana Garcia. Cardiovascular Disease in Women. Circulation Research. Volume: 118, Issue: 8, Pages: 1273-1293, DOI: (10.1161/CIRCRESAHA.116.307547)

• Leon R. Step by step approach to determine the safety of prescribing hormone replacement therapy. The University of British Columbia Continuing Professional Development Faculty of Medicine. June 20, 2017. https:// thischangedmypractice.com/determine-safety-of-prescribing-hrt/