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Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator
Authors:Marlene Montesino  David F. Archer  Jaâfar Zerhouni  Isabelle Côté  Lyne Lavoie
Affiliation:1. EndoCeutics Inc, Quebec City, Quebec, G1V 4M7, Canada,;2. Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA,
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.
Keywords:Dyspareunia  prasterone  vaginal applicator  vaginal dryness  vulvovaginal atrophy
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