Clinical Review
2015 Update on menopause
The latest guidance on safe use of menopausal hormone therapy


Dr. Pinkerton is Professor, Department of Obstetrics and Gynecology, and Director, Division of Midlife Women’s Health, at the University of Virginia in Charlottesville. Dr. Pinkerton is a North American Menopause Society (NAMS) past president and certified menopause practitioner. She also serves on the OBG Management Board of Editors.

Dr. Simon is Clinical Professor, Department of Obstetrics and Gynecology, George Washington University, and Medical Director, Women’s Health & Research Consultants, Washington, DC. Dr. Simon is a NAMS past president, a certified menopause practitioner, and clinical densitometrist. He also serves on the OBG Management Board of Editors.
Dr. Pinkerton and Dr. Simon provided peer review and comments for Dr. Kaunitz’s case study.
Disclosures
Dr. Kaunitz reports that within the past 36 months, he has received or is currently receiving grant or research support from Bayer, Teva, and TherapeuticsMD, and has served or is currently serving as a consultant to Actavis, Bayer, and Teva.
Dr. Pinkerton reports that within the past 36 months, she has received or is currently receiving grant or research support from TherapeuticsMD and has served or is currently serving as a consultant to Noven, Inc., Pfizer, Shionogi, and TherapeuticsMD.
Dr. Simon reports that within the past 36 months, he has been a consultant to or served on the advisory boards of AbbVie, Actavis, Amgen, Amneal, Apotex, Ascend Therapeutics, BioSante, Depomed, Dr. Reddy Laboratories, Everett Laboratories, Intimina by Lelo, Lupin, Meda, Merck, Novartis, Noven, Novo Nordisk, Nuelle, Pfizer, Regeneron, Sanofi SA, Sermonix, Shionogi, Shippan Point Advisors, Sprout, Teva, TherapeuticsMD, Warner Chilcott, and Watson.
In the past 36 months, Dr. Simon has received grant/research support from AbbVie, Actavis, Agile Therapeutics, Bayer Healthcare, EndoCeutics, New England Research Institute, Novo Nordisk, Palatin Technologies, Teva, and TherapeuticsMD.
Within the past 36 months, Dr. Simon has also served on the speaker’s bureaus of Amgen, Eisai, Merck, Novartis, Noven, Novo Nordisk, Shionogi, Teva, and Warner Chilcott.
Dr. Simon served as Chief Medical Officer of Sprout Pharmaceuticals until April 1, 2013.

Dr. Simon
Nevertheless, I think it is important to point out that a properly powered study to assess actual risk in this setting is not available in the literature.
When a patient refuses HT
Dr. Pinkerton
Some BRCA mutation carriers may refuse HT despite reassurance that it is safe. Nonhormonal therapies are not as effective at relieving severe menopausal symptoms. Almost all selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) can be offered, although only low-dose paroxetine salt is approved for treatment of postmenopausal hot flashes.10,11 Gabapentin also has shown efficacy in relieving hot flashes.
For genitourinary syndrome of menopause (GSM; formerly known as vulvovaginal atrophy), lubricants and moisturizers may provide some benefit, but they don’t improve the vaginal superficial cells and, therefore, are not as effective as hormonal options. There is now a selective estrogen receptor modulator (SERM) approved to treat GSM—ospemifene. However, in clinical trials, ospemifene has been shown to increase hot flashes, so it would not be a good option for our patient.12
Case: Continued
Christine follows up 3 months after initiating estrogen therapy (oral estradiol 2 mg daily). She reports significant improvement in her hot flashes, with improved sleep and fewer sleep disruptions. In addition, she feels that her “mental sharpness” has returned.
Dr. Pinkerton
What if this patient had an intact uterus? Then she would not be a candidate for estrogen-only therapy because she would need continued endometrial protection. Options then would include low-dose continuous or cyclic progestogen therapy, often starting with micronized progesterone, as the E3N Study suggested it has a less negative effect on the uterus.13 Or she could use a levonorgestrel-releasing intrauterine system off label, as Ms. Jolie Pitt elected to do.
Another option would be combining estrogen with a SERM. The only estrogen/SERM combination currently approved by the US Food and Drug Administration (FDA) is conjugated estrogen/bazedoxefine, which showed no increase in breast tenderness, breast density, or bleeding rates, compared with placebo, in multiple trials up to 5 years in duration.14
Case: Resolved
Christine says she would like to continue HT, although she still experiences dryness and discomfort when sexually active with her husband, despite use of a vaginal lubricant. A pelvic examination is consistent with early changes of GSM.15
You discuss GSM with Christine and suggest that she consider 1 of 2 strategies:
Christine chooses Option 2. When she returns 6 months later for her well-woman visit, she reports that all of her menopausal symptoms have resolved, and a pelvic examination no longer reveals changes of GSM.
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