Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. (3rd March 2016)

• Record Type: Journal Article
• Authors: Montesino, Marlene; Labrie, Fernand; Archer, David F.; Zerhouni, Jaâfar; Côté, Isabelle; Lavoie, Lyne; Beauregard, Adam; Martel, Céline; Vaillancourt, Mario; Moyneur, Erick; Balser, John
• Is Part Of: Gynecological endocrinology. Volume 32:Number 3(2016:Mar.)
• Page Start: 240
• Page End: 245
• Publication Date: 2016-03-03
• Subjects: Dyspareunia -- prasterone -- vaginal applicator -- vaginal dryness -- vulvovaginal atrophy; Endocrine gynecology -- Periodicals; Generative organs, Female -- Diseases -- Periodicals; 618.1
• DOI: 10.3109/09513590.2015.1110140
• Languages: English
• ISSNs: 0951-3590

Abstract

Abstract: The objective of the study is to evaluate the acceptability of the intravaginal administration of ovules/suppositories of DHEA (dehydroepiandrosterone, prasterone) for the treatment of vulvovaginal atrophy (VVA) in women with moderate to severe dyspareunia who were administered daily for 12 weeks intravaginal 0.50% (6.5 mg) DHEA or placebo. There were a total of 373 women in the per-protocol population who responded to the questionnaire for both treatment groups. While it was planned that the applicator would be evaluated as suitable if at least 80% of participants have a global score ≤ 2 units, 99% and 100% of participants had a score ≤ 2 units in the placebo and DHEA groups, respectively, for the global score (mean of 5 questions). When asked about like and dislike the technique of drug administration, 284 comments were positive, while 114 women gave no comment. About 92–94% of women indicated that they were very confident to be able use the applicator successfully in the future. The survey shows a high degree of satisfaction and of confidence to use the applicator successfully in the future.