HER2 Support Group Forums - new non-hormonal SERM (medication) may help vulvovaginal atrophy without increased bc

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Reproductive Biology | 25/77 in Obstetrics & GynecologySource:2012 Journal Citation Reports® (Thomson Reuters, 2013)

Profile of Ospemifene in the Breast
Sarah L. Berga, MD1,2⇑
1Department of Obstetrics and Gynecology, Wake Forest School of Medicine, Winston–Salem, NC, USA
2Women's Health, Wake Forest Baptist Health, Winston–Salem, NC, USA
Sarah L. Berga, Wake Forest Baptist Health, Medical Center Boulevard, Winston–Salem, NC 27157, USA. Email: sberga@wakehealth.edu
Abstract

Vulvar and vaginal atrophy (VVA) is a chronic, progressive medical condition prevalent among postmenopausal women, which produces symptoms such as dyspareunia, vaginal dryness, and vaginal irritation. Currently, the only prescription options are systemic and vaginal estrogen therapies that may be limited by concerns about long-term safety and breast cancer risk. Ospemifene is a tissue-selective estrogen agonist/antagonist (a selective estrogen receptor modulator) recently approved by the US Food and Drug Administration for treatment of dyspareunia, a symptom of VVA, due to menopause. Ospemifene, the first nonestrogen oral treatment for this indication, may provide an alternative to treatment with estrogen. Animal models with ospemifene suggest an inhibitory effect on growth of malignant breast tissue, but animal data cannot necessarily be extrapolated to humans. Clinical trials, including 3 long-term studies assessing the overall safety of ospemifene, support that ospemifene is generally well tolerated, with beneficial effects on the vagina, neutral effects on the breast, and minimal effects on the endometrium.