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Activity Number:
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154
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309587 |
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Title:
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A Composite Endpoint for Vulvovaginal Symptoms in VVA Clinical Trials
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Author(s):
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Moh-Jee Ng*+ and Ling Chen
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Companies:
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Food and Drug Administration and Food and Drug Administration
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Address:
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3823 Park Lake Dr, Rockville, MD, 20853,
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Keywords:
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menopausal women ; Composite Endpoints ; Vulvar and Vaginal Atrophy
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Abstract:
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Vulvar and vaginal atrophy (VVA) is an indication associated with menopausal women. Based on the draft Guidance for Industry, there are three co-primary endpoints for efficacy evaluation. One of them is mean change from baseline to week 12 in the moderate to severe symptom that has been identified by the patient as being the most bothersome to her. This endpoint is determined using five vulvovaginal symptoms which are included in the patient self-assessment questionnaires. It has been observed that some patients missed to identify this endpoint at the baseline, and some patients had more than one symptom mostly bothersome to them. In this research, we will propose a composite endpoint for evaluating vulvovaginal symptoms. Real data results will be presented in this poster.
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