title: Low dose estriol pessaries for the treatment of vaginal atrophy: a double-blind placebo-controlled trial investigating the efficacy of pessaries containing 0.2mg and 0.03mg estriol.
abstract: OBJECTIVE
  The aim of the study was to confirm the superior efficacy of estriol containing pessaries compared to placebo in the treatment of vaginal atrophy.
  
  
  METHODS
  In a prospective, multicenter, randomized, placebo-controlled, double-blind study, 436 postmenopausal women with vaginal atrophy (vaginal maturation index, VMI<40%; vaginal pH>5; most bothersome symptom, MBS≥65 on visual analogue scale, VAS) were treated with pessaries containing either 0.2mg estriol (N=142) or 0.03mg estriol (N=147) or with a matching placebo (N=147) for 12 weeks.
  
  
  METHODS
  Primary efficacy endpoints included increase in VMI, decrease of the vaginal pH value and decrease in intensity of MBS after 12 weeks of treatment.
  
  
  RESULTS
  The increase in VMI was significantly greater under 0.2mg estriol and 0.03mg estriol (46.3±17.0 and 38.4±19.4, respectively) compared to placebo (23.9±21.5; p values<0.001), vaginal pH decreased significantly more (-1.6±0.8 and -1.4±0.9, respectively) compared to placebo (-0.6±0.8; p values<0.001) and MBS intensity (VAS) declined significantly more (-52.2±23.7 and -47.1±23.4, respectively) compared to placebo (-31.8±26.3; p values<0.001). Adverse events were rare and occurred at similar rates in all three groups.
  
  
  CONCLUSIONS
  Superiority of estriol containing pessaries over placebo was shown in the local treatment of vaginal atrophy. Even a very low dose of 0.03mg estriol proved sufficient for local treatment of vaginal atrophy with excellent tolerability.
authors.affiliation: ZPZ, Center of Pathology and Cytodiagnostics, Emil-Hoffmann-Straße 7a, D-50996 Cologne, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Griesser
authors.forename: Stefan
authors.initials: S
authors.lastname: Skonietzki
authors.forename: Thomas
authors.initials: T
authors.lastname: Fischer
authors.forename: Karin
authors.initials: K
authors.lastname: Fielder
authors.forename: Marija
authors.initials: M
authors.lastname: Suesskind
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy; D004311:Double-Blind Method; D004964:Estriol / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D010570:Pessaries; D017698:Postmenopause; D011446:Prospective Studies; D016896:Treatment Outcome; D014623:Vaginal Diseases / Q000150:complications / Q000188:drug therapy* / Q000473:pathology
chemical_list: D004964:Estriol