The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy.

Abstract

OBJECTIVES:

To explore clinically relevant differences in severity of vulvar and vaginal atrophy (VVA) in postmenopausal women treated with ospemifene compared with placebo.

METHODS:

Analysis of two multicenter, randomized, double-blind, 12-week phase-III studies in postmenopausal women (40-80 years, with VVA, treated with ospemifene 60 mg/day or placebo (Study 310 and Study 821)). Severity of vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clinically relevant differences between ospemifene and placebo were analyzed and are presented as improvement (reduction in ≥ 1 unit on four-point scoring system), substantial improvement (reduction in 2-3 units on four-point scoring system) and relief (severity score of mild/none after 12 weeks).

RESULTS:

In Study 310, significantly more women with a most bothersome symptom of dyspareunia had improvement (68.3% vs. 54.1%; p = 0.0255) or relief (57.5% vs. 41.8%; p = 0.0205) in the severity of dyspareunia from baseline to week 12 with ospemifene compared with placebo. For those with a most bothersome symptom of vaginal dryness, significantly more experienced improvement (74.6% vs. 57.7%; p = 0.0101), substantial improvement (42.4% vs. 26.9%; p = 0.0172) and relief (66.1% vs. 49.0%; p = 0.0140) of vaginal dryness from baseline to week 12 with ospemifene compared with placebo. Proportions of women with improvement/substantial improvement/relief of symptoms of vaginal dryness or dyspareunia were similar in Study 821. Clinically relevant differences were noticeable by week 4.

CONCLUSIONS:

Treatment with ospemifene was consistently associated with greater improvement, substantial improvement or relief in the severity of the most bothersome symptoms of vaginal dryness or dyspareunia compared with placebo.

• Authors: R E Nappi, N Panay, N Bruyniks, C Castelo-Branco, T J De Villiers, J A Simon
• Journal: Climacteric : the journal of the International Menopause Society (Climacteric) Vol. 18 Issue 2 Pg. 233-40 (Apr 2015) ISSN: 1473-0804 [Electronic] England
• PMID: 25335119 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Selective Estrogen Receptor Modulators
• Tamoxifen
• Ospemifene

Topics

• Adult
• Aged
• Aged, 80 and over
• Atrophy
• Double-Blind Method
• Dyspareunia (drug therapy, etiology)
• Female
• Humans
• Middle Aged
• Placebos
• Selective Estrogen Receptor Modulators
• Tamoxifen (analogs & derivatives, therapeutic use)
• Treatment Outcome
• Vagina (pathology)
• Vaginal Diseases (drug therapy)
• Vulva (pathology)