Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause

Menopause. 2017 Nov;24(11):1246-1256. doi: 10.1097/GME.0000000000000910.


Objective: To analyze the effects of intravaginal prasterone obtained in the three randomized clinical studies performed in postmenopausal women suffering from moderate to severe (MS) dyspareunia due to vulvovaginal atrophy (VVA).

Methods: In three independent 12-week prospective, randomized, double-blind, and placebo-controlled clinical studies, the effect of daily intravaginal 0.50% (6.5 mg) prasterone was examined on four co-primary objectives in women having MS pain during sexual activity (dyspareunia), identified as their most bothersome symptom (MBS) of VVA at baseline.

Results: In 436 women treated with 0.50% prasterone and 260 women who received placebo, an average 35.1% decrease over placebo in the percentage of parabasal cells (P < 0.0001), an average 7.7% increase in the percentage of superficial cells (P < 0.0001), and a mean 0.72 pH unit decrease in vaginal pH (P < 0.0001) were observed. The severity score of most bothersome symptom dyspareunia was decreased by a 0.46 unit (49%) (P < 0.0001 over placebo), whereas the severity score of MS vaginal dryness decreased by 0.31 unit (P < 0.0001 over placebo). A very positive evaluation was obtained on the acceptability of the technique of administration of the insert, whereas the male partners reported a very positive evaluation of the changes observed in their sexual partner.

Conclusion: The efficacy data demonstrate highly positive effects on all the symptoms and signs of vulvovaginal atrophy with no significant drug-related side effects in line with the physiology of menopause and intracrinology.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravaginal
  • Adult
  • Aged
  • Aged, 80 and over
  • Atrophy
  • Dehydroepiandrosterone / administration & dosage
  • Dehydroepiandrosterone / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Prospective Studies
  • Surveys and Questionnaires
  • Treatment Outcome
  • Vagina / pathology*
  • Vaginal Diseases / drug therapy*
  • Vaginal Diseases / pathology
  • Vulvar Diseases / drug therapy*
  • Vulvar Diseases / pathology


  • Dehydroepiandrosterone