Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women

Abstract

Ospemifene was shown to be effective and well tolerated for the treatment of the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy over and above the use of provided lubricants.

Profile of Ospemifene in the Breast

“…15 The initial 12-week study evaluated the efficacy and tolerability of ospemifene 30 mg/d and 60 mg/d in 826 women (ospemifene 30 mg, n ¼ 282; ospemifene 60 mg, n ¼ 276; placebo, n ¼ 268). 13 After completing the initial study, women with a uterus were eligible to continue blinded treatment for a total of 52 weeks (12 weeks in the initial study plus 40 weeks in the safety extension [N ¼ 180]). Safety assessments of the breast included mammograms and palpation on physical examination performed at week 52 or study discontinuation.…”

“…26,29 In three phase 3 clinical trials, ospemifene has been demonstrated to be effective and generally well tolerated in the treatment of dyspareunia, a symptom of moderate to severe VVA in postmenopausal women. 13,[30][31][32] In addition, many preclinical evaluations of ospemifene have been conducted to determine its activity in breast cancer tissue ( Table 2). [8][9][10]14,33 Although breast cancer models differ from healthy breast tissue, the preclinical studies are a starting point for further research.…”

“…[4][5][6][7] Ospemifene is a new tissue-selective estrogen agonist/antagonist recently approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe dyspareunia, a common symptom of VVA in postmenopausal women. [8][9][10][11][12][13][14][15] It is the first oral non-estrogen prescription alternative to estrogen therapies for the treatment of VVA.…”

Post-menopausal vulvovaginal atrophy — an overview of the current treatment options

“…The obtained data suggests, that the improvement confirmed by FSFI is not related to serum hormone changes but demonstrate the beneficial effect of ospemifene on vaginal mucosa. Other authors also described the effectiveness of ospemifene compared to a placebo as well as the safety of this therapy [38][39][40][41][42]. A recent review on ospemifene in the VVA treatment reported also that an oestrogenic effect of ospemifene on the bone is comparable to the bone-restoring activity of raloxifene.…”

Update on management of genitourinary syndrome of menopause: A practical guide

“…Ospemifene is a selective estrogen receptor modulator (SERM) [31]. Several studies have shown efficacy [32][33][34][35][36][37][38]. A pivotal 12 week randomized trial showed that ospemifene was shown to be effective and well tolerated for the treatment of the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy over and above the use of provided lubricants [32].Subsequent studies have confirmed efficacy and safety over 12 months.…”