title: The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy.
abstract: OBJECTIVE
  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.affiliation: Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S Matteo Foundation, University of Pavia , Pavia , Italy.
authors.forename: R E
authors.initials: RE
authors.lastname: Nappi
authors.forename: N
authors.initials: N
authors.lastname: Panay
authors.forename: N
authors.initials: N
authors.lastname: Bruyniks
authors.forename: C
authors.initials: C
authors.lastname: Castelo-Branco
authors.forename: T J
authors.initials: TJ
authors.lastname: De Villiers
authors.forename: J A
authors.initials: JA
authors.lastname: Simon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014621:Vagina / Q000473:pathology*; D014623:Vaginal Diseases / Q000188:drug therapy; D014844:Vulva / Q000473:pathology*
chemical_list: D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene
keywords: DYSPAREUNIA; OSPEMIFENE; RANDOMIZED CLINICAL TRIALS; VAGINAL DRYNESS; VULVAR AND VAGINAL ATROPHY