Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause. Issue 11 (November 2017)

• Record Type: Journal Article
• Authors: Labrie, Fernand; Archer, David F.; Martel, Céline; Vaillancourt, Mario; Montesino, Marlene
• Is Part Of: Menopause. Volume 24:Issue 11(2017)
• Publication Date: 2017-11
• Subjects: Dehydroepiandrosterone -- Dryness -- Dyspareunia -- Intracrinology -- Menopause -- Prasterone -- Vulvovaginal atrophy; Menopause -- Periodicals; 618.175005
• DOI: 10.1097/GME.0000000000000910
• Languages: English
• ISSNs: 1072-3714

Abstract

Abstract: 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.