The Medical Letter on Drugs and Therapeutics
FROM
ISSUE 1575
ISSUE 1575
July 1, 2019
Estradiol/Progesterone (Bijuva) for Menopausal Vasomotor Symptoms
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July 1, 2019 (Issue: 1575)
The FDA has approved Bijuva (TherapeuticsMD), a
fixed-dose combination of estradiol and progesterone,
for oral treatment of moderate to severe vasomotor
symptoms (hot flashes) due to menopause in women
with an intact uterus. The manufacturer is marketing
Bijuva as "the first and only FDA-approved combination
of bio-identical estradiol and bio-identical progesterone
in a single daily oral capsule".
... more
- ACOG. Committee Opinion No. 532: compounded bioidentical menopausal hormone therapy. Obstet Gynecol 2012; 120 (2 Pt 1):411.
- FZ Stanczyk et al. Determination of estradiol and progesterone content in capsules and creams from compounding pharmacies. Menopause 2019 June 3 (epub).
- N Santoro et al. Compounded bioidentical hormones in endocrinology practice: an Endocrine Society Scientific Statement. J Clin Endocrinol Metab 2016; 101:1318.
- AM Gaudard et al. Bioidentical hormones for women with vasomotor symptoms. Cochrane Database Syst Rev 2016; 8:CD010407.
- Drugs for menopausal symptoms. Med Lett Drugs Ther 2016; 58:142.
- JL Shifren et al. Menopausal hormone therapy. JAMA 2019 May 30 (epub).
- RH Cobin et al. American Association of Clinical Endocrinologists and American College of Endocrinology position statement on menopause – 2017 update. Endocr Pract 2017; 23:869.
- RA Lobo et al. A 17ß-estradiol–progesterone oral capsule for vasomotor symptoms in postmenopausal women: a randomized controlled trial. Obstet Gynecol 2018; 132:161.
- FDA Summary Review. Available at: www.accessdata.fda.gov. Accessed June 20, 2019.
- JE Manson et al. Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the women's health initiative randomized trials. JAMA 2017; 318:927.
- Y Vinogradova. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ 2019; 364:k4810.
- Inhibitors and inducers of CYP enzymes and P-glycoprotein. Med Lett Drugs Ther 2017 March 12 (epub). Available at: medicalletter.org/downloads/CYP_PGP_Tables.pdf.

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Title: Estradiol Progesterone (Bijuva) for Menopausal Vasomotor Symptoms
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