title: Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study.
abstract: OBJECTIVE
  An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5% (6.5mg) DHEA (prasterone) for 52 weeks on the moderate to severe (MS) symptoms and signs of vulvovaginal atrophy (VVA).
  
  
  METHODS
  Five hundred twenty-one postmenopausal women were enrolled and received daily intravaginal administration of 0.5% DHEA in an open-label phase III study. The severity of the VVA symptoms examined in detail in the different groups.
  
  
  RESULTS
  A parallel improvement of pain at sexual activity was observed in women who had moderate to severe (MS) dyspareunia as their most bothersome symptom (MBS) (n=183) or not MBS (n=240) and MS without being MBS (n=57) with a 1.70 severity unit change in the MBS group for a decrease of 66.1% from baseline (p<0.0001 versus baseline) over 52 weeks. A further improvement of dyspareunia, namely 0.33 severity unit (19.4%), was observed with continuing treatment from 12 weeks to 52 weeks. Similar results were observed on vaginal dryness and irritation/itching. Highly significant beneficial effects (p<0.0001 versus baseline for all) were observed at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness.
  
  
  CONCLUSIONS
  The present study shows, in addition to the parallel benefits on the three symptoms of VVA, that the choice of any of the MS symptoms as being or not being MBS by women has no influence on the observed therapeutic effect (NCT01256671).
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada. Electronic address: Fernand.Labrie@endoceutics.com.
authors.forename: Fernand
authors.initials: F
authors.lastname: Labrie
authors.affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.affiliation: Clinique de Recherche en Santé des Femmes, Quebec City, QC, Canada.
authors.forename: Céline
authors.initials: C
authors.lastname: Bouchard
authors.affiliation: Diex Recherche Inc., Sherbrooke, QC, Canada.
authors.forename: Ginette
authors.initials: G
authors.lastname: Girard
authors.affiliation: Clinique de Gynécologie, Shawinigan, QC, Canada.
authors.forename: Normand
authors.initials: N
authors.lastname: Ayotte
authors.affiliation: Creighton University Medical Center, Omaha, NE, USA.
authors.forename: John C
authors.initials: JC
authors.lastname: Gallagher
authors.affiliation: Clinique de Recherche en Traitements Hormonaux, Quebec City, QC, Canada.
authors.forename: Leonello
authors.initials: L
authors.lastname: Cusan
authors.affiliation: Rapid Medical Research Inc., Cleveland, OH, USA.
authors.forename: Mira
authors.initials: M
authors.lastname: Baron
authors.affiliation: Pro-Recherche, St-Romuald, QC, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Blouin
authors.affiliation: Downtown Women's Health Care, Denver, CO, USA.
authors.forename: Arthur S
authors.initials: AS
authors.lastname: Waldbaum
authors.affiliation: Medical Center for Clinical Research, San Diego, CA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Koltun
authors.affiliation: Columbus Center for Women's Health Research, Columbus, OH, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Portman
authors.affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Côté
authors.affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: Lyne
authors.initials: L
authors.lastname: Lavoie
authors.affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Beauregard
authors.affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: Claude
authors.initials: C
authors.lastname: Labrie
authors.affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: Céline
authors.initials: C
authors.lastname: Martel
authors.affiliation: Veristat, Holliston, MA, USA.
authors.forename: John
authors.initials: J
authors.lastname: Balser
authors.affiliation: StatLog Consulting Inc., Ottawa, ON, Canada.
authors.forename: Érick
authors.initials: É
authors.lastname: Moyneur
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D001284:Atrophy / Q000150:complications / Q000188:drug therapy; D003687:Dehydroepiandrosterone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy / Q000209:etiology; D005260:Female; D006728:Hormones / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011537:Pruritus / Q000188:drug therapy; D012720:Severity of Illness Index; D012725:Sexual Behavior; D014621:Vagina / Q000473:pathology*; D014623:Vaginal Diseases / Q000150:complications / Q000188:drug therapy*; D014844:Vulva / Q000473:pathology*; D014845:Vulvar Diseases / Q000150:complications / Q000188:drug therapy*
chemical_list: D006728:Hormones; D003687:Dehydroepiandrosterone
keywords: Dehydroepiandrosterone; Local action; Prasterone; Secondary symptomatology; Vulvovaginal atrophy