Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator

Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.


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.

Keywords: Dyspareunia; prasterone; vaginal applicator; vaginal dryness; vulvovaginal atrophy.

Publication types

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

MeSH terms

  • Administration, Intravaginal
  • Atrophy / drug therapy
  • Dehydroepiandrosterone / administration & dosage*
  • Double-Blind Method
  • Dyspareunia / drug therapy*
  • Female
  • Humans
  • Patient Acceptance of Health Care
  • Prospective Studies
  • Vagina / pathology
  • Vaginal Diseases / drug therapy*


  • Dehydroepiandrosterone