title: Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of ospemifene, a novel selective oestrogen receptor modulator, in the treatment of vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA).
  
  
  METHODS
  A 12 week, multicentre, randomised, double-blind, parallel-group phase III study of women (40-80 years) with VVA and self-reported vaginal dryness as their most bothersome symptom.
  
  
  METHODS
  The co-primary efficacy endpoints were the change from baseline to Week 12 in (1) percentage of parabasal cells in the maturation index (MI), (2) percentage of superficial cells in the MI, (3) vaginal pH, and (4) severity of vaginal dryness. Safety assessments included physical examination, cervical Papanicolaou test and clinical laboratory analyses. Endometrial thickness and histology was also assessed.
  
  
  RESULTS
  A total of 314 women were randomised to once-daily ospemifene 60 mg/day (n=160) or placebo (n=154). Significant improvements in the percentages of parabasal and superficial cells in the MI and vaginal pH were observed with ospemifene compared with placebo (p<0.001 for all parameters). The mean change from baseline in severity score of vaginal dryness reported by women receiving ospemifene compared with those receiving placebo approached statistical significance (p=0.080). Improvements in each of the four co-primary endpoints with ospemifene were statistically significant compared to placebo in the per protocol population. The majority of treatment-emergent adverse events were considered mild to moderate in severity.
  
  
  CONCLUSIONS
  Once-daily oral ospemifene 60 mg was effective for the treatment of VVA in postmenopausal women with vaginal dryness.
authors.affiliation: Columbus Center for Women's Health Research, Columbus, OH 43213, USA. Electronic address: dportman@ccwhr.com.
authors.forename: D
authors.initials: D
authors.lastname: Portman
authors.affiliation: Instituto Palacios de Salud y Medicina de la Mujer, c/Antonio Acuña n°9, 28009 Madrid, Spain. Electronic address: spalacios@institutopalacios.com.
authors.forename: S
authors.initials: S
authors.lastname: Palacios
authors.affiliation: Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S. Matteo Foundation, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy. Electronic address: renappi@tin.it.
authors.forename: R E
authors.initials: RE
authors.lastname: Nappi
authors.affiliation: University Women's Hospital, Tübingen, Germany. Electronic address: A.O.Mueck@t-online.de.
authors.forename: A O
authors.initials: AO
authors.lastname: Mueck
mesh_terms: D000368:Aged; D001284:Atrophy; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D017698:Postmenopause; D020845:Selective Estrogen Receptor Modulators / Q000494:pharmacology / Q000627:therapeutic use*; D013629:Tamoxifen / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; 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: Dyspareunia; Ospemifene; Postmenopausal; Vaginal dryness; Vulvar and vaginal atrophy