Volume 77, Issue 3
Dyspareunia--drug therapy; Postoperative Complications--drug therapy; Selective Estrogen Receptor Modulators--adverse effects; Tamoxifen--analogs & derivatives; Vagina--drug effects; Vulva--drug effects
To examine the long-term safety of oral ospemifene, a non-estrogen tissue-selective estrogen agonist/antagonist, for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
This multicenter, long-term, open-label, safety extension study was conducted in women without a uterus aged 40–80 years (N = 301) who received oral ospemifene 60 mg/day for 52 weeks. Participants either continued their 60-mg/day ospemifene dose from the initial 12-week pivotal efficacy study or switched from blinded placebo or ospemifene 30 mg/day to open-label ospemifene 60 mg/day. The 52-week open-label extension period plus initial 12-week treatment period totaled up to 64 weeks of ospemifene exposure. A 4-week posttreatment follow-up ensued (68 weeks total).
Main outcome measures
Safety assessments included adverse events, laboratory studies, physical and gynecologic examination, vital signs, breast palpation, and mammography.
Most treatment-emergent adverse events (TEAEs) during the extension study were mild or moderate in severity. The most common TEAE related to study drug was hot flushes (10%; leading to discontinuation for 2% of patients). One serious TEAE, a non-ST-elevation myocardial infarction in a patient with pre-existing cardiac disease, was considered possibly related to study medication. One mild breast-related TEAE, considered unrelated to study drug, was ongoing at study completion. There were no instances of pelvic organ prolapse, incontinence, venous thromboembolism, fractures, breast cancers or death. No clinically significant adverse changes were observed in other safety parameters.
Ospemifene is clinically safe and generally well tolerated in postmenopausal patients with dyspareunia, a symptom of VVA.
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Simon, J., Portman, D., Mabey, R.G. et al. (2014). Long-term safety of ospemifene (52-week extension) in the treatment of vulvar and vaginal atrophy in hysterectomized postmenopausal women. Maturitas, 77(3), 274-281.