Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause.

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.

• Authors: Fernand Labrie, David F Archer, Céline Martel, Mario Vaillancourt, Marlene Montesino
• Journal: Menopause (New York, N.Y.) (Menopause) Vol. 24 Issue 11 Pg. 1246-1256 (Nov 2017) ISSN: 1530-0374 [Electronic] United States
• PMID: 28640161 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Dehydroepiandrosterone

Topics

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