Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study

Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16.


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).

Method: 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.

Conclusion: 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).

Keywords: Dehydroepiandrosterone; Local action; Prasterone; Secondary symptomatology; Vulvovaginal atrophy.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravaginal
  • Adult
  • Aged
  • Atrophy / complications
  • Atrophy / drug therapy
  • Dehydroepiandrosterone / administration & dosage*
  • Double-Blind Method
  • Dyspareunia / drug therapy
  • Dyspareunia / etiology
  • Female
  • Hormones / administration & dosage*
  • Humans
  • Middle Aged
  • Postmenopause
  • Pruritus / drug therapy
  • Severity of Illness Index
  • Sexual Behavior
  • Vagina / pathology*
  • Vaginal Diseases / complications
  • Vaginal Diseases / drug therapy*
  • Vulva / pathology*
  • Vulvar Diseases / complications
  • Vulvar Diseases / drug therapy*


  • Hormones
  • Dehydroepiandrosterone

Associated data