title: Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial.
abstract: OBJECTIVE
  To prove non-inferiority of the first non-hormonal vaginal cream in Germany, Vagisan(®) Moisturising Cream (CREAM), compared to a non-hormonal vaginal gel (GEL) for vulvovaginal atrophy (VVA) symptom relief.
  
  
  METHODS
  This was a 12-week multicenter, open-label, prospective, randomized, two-period, cross-over phase-III trial. The primary endpoint was the cumulative VVA subjective symptom score of the respective treatment period. Secondary endpoints were assessment of single VVA subjective and objective symptoms, VVA objective symptom score, vaginal pH, safety parameters, overall assessment of efficacy, tolerability and evaluation of product properties. In total, 117 women were randomly allocated to either one of the two treatments, each administered for 4 weeks; 92 women were included in the per-protocol analysis (primary analysis). The main outcome measure was cumulative VVA subjective symptom score.
  
  
  RESULTS
  Regarding VVA symptom relief, results confirmed non-inferiority of CREAM compared to GEL and even indicated superiority of CREAM. Frequency and intensity of subjective symptoms and objective findings were clearly reduced, with CREAM showing better results compared to GEL. Mean VVA objective symptom score significantly decreased; improvement was significantly greater with CREAM. Vaginal pH decreased only following CREAM treatment. Tolerability was superior for CREAM: burning and itching, mostly rated as mild, occurred markedly less often with CREAM than with GEL. Overall satisfaction with treatment efficacy, tolerability and most product properties were rated significantly superior for CREAM.
  
  
  CONCLUSIONS
  Subjective and objective VVA symptoms were reliably and safely reduced by both non-hormonal topical products. However, efficacy and tolerability of CREAM were shown to be superior to GEL.
authors.affiliation: Department of Obstetrics and Gynecology , University of Bern , Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Stute
authors.forename: T W
authors.initials: TW
authors.lastname: May
authors.forename: C
authors.initials: C
authors.lastname: Masur
authors.forename: I M
authors.initials: IM
authors.lastname: Schmidts-Winkler
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy / Q000188:drug therapy; D018592:Cross-Over Studies; D004655:Emulsions / Q000627:therapeutic use; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008875:Middle Aged; D009821:Oils / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*; D014623:Vaginal Diseases / Q000188:drug therapy* / Q000473:pathology
chemical_list: D004655:Emulsions; D009821:Oils; D014622:Vaginal Creams, Foams, and Jellies
keywords: NON-HORMONAL VAGINAL THERAPY; VAGINAL CREAM; VAGINAL DRYNESS; VAGINAL GEL; VAGINAL pH; VULVOVAGINAL ATROPHY