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

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.

Chinese abstract

研究的目的为评估阴道内给予 DHEA（脱氢表雄酮，普拉睾酮）卵剂/塞剂用于缓解伴有严重性交痛的阴道萎缩（VVA）妇女缓解每日阴道内给予0.50% (6.5 mg) DHEA或安慰剂治疗的可接受性。符合方案人群中总计有373位妇女回答了两个治疗组的调查问卷。虽然计划通过达到至少80%患者给予敷贴器整体得分（5个问题的平均值）≤2单位来评定敷贴器是否合适，对敷贴器的整体评分为≤2单位的安慰剂组患者和DHEA组患者分别为99%和100%。当询问患者对于这种上药技术的好恶时，284名患者给予了正面评价，114名妇女未作评论。约92–94%的妇女表示，她们对于将来成功使用此敷贴器的能力非常自信。调查表明了患者对敷贴器的高度满意和在将来成功使用此敷贴器的自信。

• Dyspareunia
• prasterone
• vaginal applicator
• vaginal dryness
• vulvovaginal atrophy

Acknowledgements

We thank all members of the Prasterone clinical research team for their much appreciated and important collaboration.

Declaration of interest

This research was sponsored by EndoCeutics. Marlene Montesino, Jaâfar Zerhouni, Isabelle Côté, Lyne Lavoie, Adam Beauregard, Céline Martel and Mario Vaillancourt are employes of EndoCeutics, while Fernand Labrie is chief executive officer. Erick Moyneur and John Balser are consultants. David F. Archer receives grants from EndoCeutics for clinical studies.