title: High internal consistency and efficacy of intravaginal DHEA for vaginal atrophy.
abstract: Following the compelling data obtained in a pivotal phase III clinical trial performed in 218 postmenopausal women suffering from vaginal atrophy who received daily intravaginal 0.25, 0.5 or 1.0% DHEA (dehydroepiandrosterone) ovules for 12 weeks, we have performed analysis of the four co-primary objectives at each site of that multicentre U.S. and Canadian trial. Comparison was made of the change in percentage of parabasal and superficial cells, vaginal pH and severity of the most bothersome symptom. The site-by-site (seven sites) analysis has shown that 10-13 women per group are generally sufficient to obtain a significant or highly statistically significant decrease in vaginal pH and percentage of parabasal cells and increased percentage of superficial cells at p values ranging from 0.02 to <0.0001. For vaginal pain as the most bothersome symptom, a statistically significant difference from baseline was found at six out of seven sites. The exceptionally high consistency between all sites in this phase III study and high potency of the compound permit to obtain a clinically and statistically significant to highly significant effect of treatment on all parameters of vaginal atrophy with the 0.5% DHEA daily intravaginal dose which does not significantly affect the serum levels of oestrogens, thus avoiding systemic risks.
authors.affiliation: Laval University Hospital Research Center (CRCHUL), Laval University, Quebec City, Quebec, Canada. fernand.labrie@endoceutics.com
authors.forename: Fernand
authors.initials: F
authors.lastname: Labrie
authors.forename: David
authors.initials: D
authors.lastname: Archer
authors.forename: Céline
authors.initials: C
authors.lastname: Bouchard
authors.forename: Michel
authors.initials: M
authors.lastname: Fortier
authors.forename: Leonello
authors.initials: L
authors.lastname: Cusan
authors.forename: José-Luis
authors.initials: JL
authors.lastname: Gomez
authors.forename: Ginette
authors.initials: G
authors.lastname: Girard
authors.forename: Mira
authors.initials: M
authors.lastname: Baron
authors.forename: Normand
authors.initials: N
authors.lastname: Ayotte
authors.forename: Michèle
authors.initials: M
authors.lastname: Moreau
authors.forename: Robert
authors.initials: R
authors.lastname: Dubé
authors.forename: Isabelle
authors.initials: I
authors.lastname: Côté
authors.forename: Claude
authors.initials: C
authors.lastname: Labrie
authors.forename: Lyne
authors.initials: L
authors.lastname: Lavoie
authors.forename: Louise
authors.initials: L
authors.lastname: Berger
authors.forename: Céline
authors.initials: C
authors.lastname: Martel
authors.forename: John
authors.initials: J
authors.lastname: Balser
mesh_terms: D000282:Administration, Intravaginal; D001284:Atrophy / Q000188:drug therapy / Q000473:pathology; D003687:Dehydroepiandrosterone / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D017698:Postmenopause / Q000187:drug effects; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects* / Q000473:pathology*; D014623:Vaginal Diseases / Q000188:drug therapy* / Q000473:pathology
chemical_list: D003687:Dehydroepiandrosterone