title: Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy.
abstract: BACKGROUND
  Previous data have shown that intravaginal dehydroepiandrosterone (DHEA, prasterone) improved all the domains of sexual function, an effect most likely related to the local formation of androgens from DHEA.
  
  
  OBJECTIVE
  To confirm in a placebo-controlled, prospective, double-blind and randomized study the benefits of daily intravaginal DHEA for 12 weeks on sexual function using the Female Sexual Function Index (FSFI) questionnaire.
  
  
  METHODS
  Placebo was administered daily to 157 women while 325 women received 0.50% (6.5 mg) DHEA daily for 12 weeks. All women were postmenopausal meeting the criteria of vulvovaginal atrophy (VVA), namely moderate to severe dyspareunia as their most bothersome symptom of VVA in addition to having ≤5% of vaginal superficial cells and vaginal pH > 5.0. The FSFI questionnaire was filled at baseline (screening and day 1), 6 weeks and 12 weeks. Comparison between DHEA and placebo of the changes from baseline to 12 weeks was made using the analysis of covariance test, with treatment group as the main factor and baseline value as the covariate.
  
  
  METHODS
  The six domains and total score of the FSFI questionnaire were evaluated.
  
  
  RESULTS
  The FSFI domain desire increased over placebo by 0.24 unit (+49.0%, P = 0.0105), arousal by 0.42 unit (+56.8%, P = 0.0022), lubrication by 0.57 unit (+36.1%, P = 0.0005), orgasm by 0.32 unit (+33.0%, P = 0.047), satisfaction by 0.44 unit (+48.3%, P = 0.0012), and pain at sexual activity by 0.62 unit (+39.2%, P = 0.001). The total FSFI score, on the other hand, has shown a superiority of 2.59 units in the DHEA group over placebo or a 41.3% greater change than placebo (P = 0.0006 over placebo).
  
  
  CONCLUSIONS
  The present data show that all the six domains of the FSFI are improved over placebo (from P = 0.047 to 0.0005), thus confirming the previously observed benefits of intravaginal DHEA on female sexual dysfunction by an action exerted exclusively at the level of the vagina, in the absence of biologically significant changes of serum steroids levels.
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Fernand
authors.initials: F
authors.lastname: Labrie
authors.affiliation: Maryland Center for Sexual Health, Lutherville, MD, USA.
authors.forename: Leonard
authors.initials: L
authors.lastname: Derogatis
authors.affiliation: CONRAD Clinical Research Center, Norfolk, VA, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.affiliation: Medical Center for Clinical Research, San Diego, CA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Koltun
authors.affiliation: Clinique Médicale St-Louis (recherche) Inc, Quebec City, QC, Canada.
authors.forename: Andrée
authors.initials: A
authors.lastname: Vachon
authors.affiliation: Northern California Research, Sacramento, CA, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Young
authors.affiliation: Q&T Recherche Sherbrooke, Sherbrooke, QC, Canada.
authors.forename: Louise
authors.initials: L
authors.lastname: Frenette
authors.affiliation: Columbus Center for Women's Health Research, Columbus, OH, USA.
authors.forename: David
authors.initials: D
authors.lastname: Portman
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Marlene
authors.initials: M
authors.lastname: Montesino
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Côté
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Julie
authors.initials: J
authors.lastname: Parent
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Lyne
authors.initials: L
authors.lastname: Lavoie
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Adam
authors.initials: A
authors.lastname: Beauregard
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Céline
authors.initials: C
authors.lastname: Martel
authors.affiliation: EndoCeutics Inc., Quebec City, QC, Canada.
authors.forename: Mario
authors.initials: M
authors.lastname: Vaillancourt
authors.affiliation: Veristat, Boston, 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; D003687:Dehydroepiandrosterone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009948:Orgasm; D010549:Personal Satisfaction; D017698:Postmenopause / Q000187:drug effects; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D014621:Vagina / Q000187:drug effects* / Q000473:pathology*; D014844:Vulva / Q000187:drug effects* / Q000473:pathology*
chemical_list: D003687:Dehydroepiandrosterone
keywords: Androgens; Arousal; Dehydroepiandrosterone (DHEA); Desire; Female Sexual Dysfunction; Female Sexual Function Index (FSFI); Intracrinology; Postmenopause; Prasterone