title: Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial.
abstract: BACKGROUND
  Ospemifene is a non-estrogen, tissue selective estrogen receptor agonist/antagonist, or selective estrogen receptor modulator, recently approved for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Postmenopausal dyspareunia is often associated with female sexual dysfunction (FSD). In this report, we present data that demonstrate the effect of ospemifene 60 mg/day on FSD assessed by the Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain).
  
  
  METHODS
  A phase-3, randomized, double-blind, 12-week trial (n = 919) compared the efficacy and safety of oral ospemifene 60 mg/day vs. placebo in postmenopausal women with VVA in two strata based on self-reported, most bothersome symptom of either dyspareunia or dryness. Primary data were published previously. We report herein pre-specified secondary efficacy endpoints analyses, including changes from baseline to Weeks 4 and 12 for FSFI total and domain scores as well as serum hormone levels.
  
  
  RESULTS
  Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001). Improvement in FSFI scores continued to Week 12 (p < 0.001). At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05). Changes in serum hormones were minor and uncorrelated with changes in sexual functioning.
  
  
  CONCLUSIONS
  In a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA. Consistent effects across FSFI domains were observed.
authors.affiliation: EndoRheum Consultants , Media, PA.
authors.forename: G
authors.initials: G
authors.lastname: Constantine
authors.forename: S
authors.initials: S
authors.lastname: Graham
authors.forename: D J
authors.initials: DJ
authors.lastname: Portman
authors.forename: R C
authors.initials: RC
authors.lastname: Rosen
authors.forename: S A
authors.initials: SA
authors.lastname: Kingsberg
mesh_terms: D000368:Aged; D001284:Atrophy; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy; D005260:Female; D006728:Hormones / Q000097:blood; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy* / Q000209:etiology; D011795:Surveys and Questionnaires; D013629:Tamoxifen / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014621:Vagina / Q000473:pathology*; D014844:Vulva / Q000473:pathology*
chemical_list: D006728:Hormones; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene
keywords: DYSPAREUNIA; FEMALE SEXUAL DYSFUNCTION; MENOPAUSE; OSPEMIFENE; TISSUE-SELECTIVE ESTROGEN AGONIST/ANTAGONIST; VULVAR AND VAGINAL ATROPHY