First Bio-Identical Hormone Therapy Approved by FDA for Moderate to Severe Vasomotor Symptoms of Menopause

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Estrogen therapy for postmenopausal vasomotor symptoms (hot flashes) was ubiquitous until the Women's Health Initiative Trials demonstrated increased breast cancer and stroke among hormone users (1), however, at 10 years all cause mortality was similar between he treated and control groups.(2) Currently, the Endocrine Society guidelines recommend a risk based approach to treating vasomotor syndromes with estrogen in women younger than 60.(3)  Most experts recommend against using compounded bio-identical hormone therapy due to a availability of FDA approved medications and a lack of demonstrated efficacy of the compounded agents. However, recent data suggests that bio-identical hormones are both safe and effective in reducing hot flashes in postmenopausal women.  Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg,  a bio-identical hormone therapy combination for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus was recently approved by the FDA. Approval was based on the Replenish Trial, a phase 3 study that demonstrated that both estradiol 1 mg/progesterone 100 mg and estradiol 0.5 mg/progesterone 100 mg significantly better than placebo at reducing the frequency and severity of hot flashes and reported no endometrial hyperplasia or malignancy.

1. Rossouw JE, Anderson GL, Prentice RL, et al. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin inhealthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288(3):321–333.

2. Manson JE, Aragaki AK, Rossouw JE et al. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA. 2017 Sep 12;318(10):927-938.

3. Stuenkel CA, Davis SR, Gompel A, Lumsden MA, Murad MH, Pinkerton JV, Santen RJ. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(11):3975.

Additional information about Conjugated Estrogens, Topical Estradiol, Progesterone,  Medroxyprogesterone, Estradiol can be found in the Top 300 Pharmacy Drug Cards or the Top 100 Nonprescription Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Flash Card section.  If your institution does not provide access, ask your medical librarian about subscribing.

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Jill Kolesar & Lee Vermeulen

Professors, University of Kentucky