Profile of ospemifene in the breast.
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.
Department of Obstetrics and Gynecology, Wake Forest School of Medicine, Winston-Salem, NC, USA. sberga@wakehealth.edu
Sarah L
SL
Berga
D000818:Animals; D001940:Breast / Q000187:drug effects / Q000378:metabolism*; D004414:Dyspareunia / Q000188:drug therapy / Q000378:metabolism; D005260:Female; D006801:Humans; D017698:Postmenopause / Q000187:drug effects / Q000378:metabolism; D020845:Selective Estrogen Receptor Modulators / Q000378:metabolism* / Q000627:therapeutic use*; D013629:Tamoxifen / Q000031:analogs & derivatives* / Q000378:metabolism / Q000627:therapeutic use; D014621:Vagina / Q000187:drug effects / Q000378:metabolism; D014844:Vulva / Q000187:drug effects / Q000378:metabolism
D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene
breast; ospemifene; selective estrogen receptor modulator; vaginal atrophy