Trial intelligence / Profile preview

Ospemifene Efficacy and Safety in VVA

NCT00566982Phase 3Completed

Sponsor
Shionogi & Co., Ltd.
Start
Oct 2007
Primary completion
Jul 2009
Modality
Small Molecules
01

Overview

Phase 3, randomised, double-blind trial in vulvovaginal atrophy (VVA) comparing Ospemifene 60 mg/day with Placebo (2 arms). Primary endpoints: Percentage of Parabasal Cells in Maturation Index of Vaginal Smear at 12 weeks, Percentage of Superficial Cells in Maturation Index of Vaginal Smear at 12 weeks and 1 more. Started Oct 2007; status: completed.

02

Drugs

ospemifene
03

Conditions

vulvovaginal atrophy (VVA)

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