title: Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet.
abstract: OBJECTIVE
  To evaluate the efficacy of ultra-low-dose 10-microgram 17beta-estradiol (E2) vaginal tablets for treatment of vaginal atrophy.
  
  
  METHODS
  Postmenopausal women (N=309) were randomly assigned to 10-microgram E2 or placebo vaginal tablets for 52 weeks in a multicenter, double-blind study. Primary efficacy endpoints included change from baseline to week 12 in vaginal cytology, vaginal pH, and most bothersome urogenital symptoms score. Grading of vaginal health was a secondary efficacy assessment. Safety assessments included endometrial biopsy, physical and gynecologic examinations, and recording adverse events.
  
  
  RESULTS
  At week 12, the change from baseline for 10 micrograms E2 compared with placebo demonstrated significant improvement in vaginal Maturation Index (proportion of parabasal cells: -37% compared with -9%; superficial cells: 13% compared with 4%; intermediate cells: 24% compared with 5%; P<.001 for each), Maturation Value (25.0 compared with 6.5, P<.001), grading of vaginal health (-0.91 compared with -0.51, P<.001), vaginal pH grade (-1.3 compared with -0.4, P<.001), and most bothersome symptoms score (-1.23 compared with -0.87, P=.003). For each component of vaginal Maturation Index, vaginal Maturation Value, grading of vaginal health, and vaginal pH, treatment effects were statistically different from placebo after 2 weeks of treatment. For most bothersome symptoms, treatment effect became apparent after 4 weeks and reached statistical significance at week 8 of therapy. All treatment effects were statistically significant at week 52. There were no major safety findings regarding physical, gynecologic, or laboratory assessments.
  
  
  CONCLUSIONS
  After 12 weeks of treatment, an ultra-low-dose 10-microgram E2 vaginal tablet, compared with placebo, demonstrated significant improvement for the primary endpoints: vaginal cytology and pH and most bothersome urogenital symptoms score.
  
  
  BACKGROUND
  ClinicalTrials.gov, http://clinicaltrials.gov, NCT00108849
  
  
  METHODS
  I.
authors.affiliation: Women's Health & Research Consultants, Washington, DC 20036, USA. jsimon@jamesasimonmd.com
authors.forename: James
authors.initials: J
authors.lastname: Simon
authors.forename: Lila
authors.initials: L
authors.lastname: Nachtigall
authors.forename: Robert
authors.initials: R
authors.lastname: Gut
authors.forename: Eva
authors.initials: E
authors.lastname: Lang
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.forename: Wulf
authors.initials: W
authors.lastname: Utian
mesh_terms: D000282:Administration, Intravaginal; D001284:Atrophy; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage*; D004967:Estrogens / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D016896:Treatment Outcome; D014623:Vaginal Diseases / Q000188:drug therapy* / Q000473:pathology
chemical_list: D004967:Estrogens; D004958:Estradiol