Considerations on the Study Design and Analysis of Vulvar and Vaginal Atrophy Studies

• Activity Number: 627
• Type: Contributed
• Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Ling Chen*+
• Companies: FDA
• Keywords: Association ; Clinical trial ; Drug efficacy ; Estrogen therapies ; Vulvar and Vaginal Atrophy

Abstract

One of the 2008 research projects supported by CDER's Regulatory Science Review Enhancement Program was to study how vulvar and vaginal atrophy (VVA) symptoms are associated, and to provide meaningful information on improving the study design and data analysis of the VVA studies. The associations among the VVA symptoms at baseline of the study for the VVA indication provide clinically meaningful information about vulvovaginal atrophy, and the associations among VVA symptoms at the end of the study (Week 12) are directly related to drug efficacy. This presentation will report the research findings, and make several recommendations on the design of the VVA studies, and on the statistical methodology used for evaluating drug efficacy of the VVA indication.