title: Effect of ospemifene on moderate or severe symptoms of vulvar and vaginal atrophy.
abstract: OBJECTIVE
  To determine whether assessment of all moderate-to-severe symptoms at baseline gives a more accurate evaluation of the treatment effect of ospemifene in vulvovaginal atrophy (VVA) than the most bothersome symptom (MBS) approach.
  
  
  METHODS
  Data were pooled from two pivotal phase-III clinical trials evaluating the efficacy and safety of oral ospemifene 60 mg/day for the treatment of symptoms of VVA (n = 1463 subjects). Symptoms of vaginal dryness, dyspareunia, and vaginal and/or vulvar irritation/itching reported as moderate or severe at baseline were evaluated. Clinically relevant differences between ospemifene and placebo were analyzed using a four-point severity scoring system and presented as improvement, substantial improvement, or relief.
  
  
  RESULTS
  Subjects in these studies reported statistically significant improvement, substantial improvement, and relief for vaginal dryness (p < 0.00001), dyspareunia (p < 0.001) and statistically significant improvement and relief for vaginal and/or vulvar irritation/itching (p < 0.01) from baseline to week 12 with ospemifene compared with placebo. A similar trend was observed for women who reported substantial improvement of vaginal and/or vulvar irritation/itching.
  
  
  CONCLUSIONS
  For drug registration purposes, the use of the MBS model is appealing because of its simplicity and ease of scientific validation. However, the MBS model may underestimate the total magnitude of the clinical benefit of ospemifene treatment for symptomatic women suffering from VVA.
authors.affiliation: a BrInPhar Ltd , Iver Heath , UK ;
authors.forename: N
authors.initials: N
authors.lastname: Bruyniks
authors.affiliation: b 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.affiliation: c Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic and Faculty of Medicine , University of Barcelona - Institut d'Investigacions Biomèdiques August Pi i Sunyer , Barcelona , Spain ;
authors.forename: C
authors.initials: C
authors.lastname: Castelo-Branco
authors.affiliation: d Mediclinic Panorama and Department of Obstetrics and Gynecology, Faculty of Health Sciences , Stellenbosch University , Parow , South Africa ;
authors.forename: T J
authors.initials: TJ
authors.lastname: de Villiers
authors.affiliation: e Department of Obstetrics and Gynecology , George Washington University, Women's Health & Research Consultants® , Washington DC , USA.
authors.forename: J
authors.initials: J
authors.lastname: Simon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy / Q000188:drug therapy; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy / Q000209:etiology; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011537:Pruritus / Q000188:drug therapy; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage* / Q000009:adverse effects; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects / Q000473:pathology*; D014623:Vaginal Diseases / Q000188:drug therapy*; D014844:Vulva / Q000187:drug effects / Q000473:pathology*
chemical_list: D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene
keywords: Vulvar and vaginal atrophy; ospemifene; randomized clinical trials