drugset / Trial / NCT01585558

Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

NCT01585558

Phase 3 Completed 180 enrolled Shionogi QuatRx Pharmaceuticals · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.

Timeline

Start
2006-05-16
Primary completion
2008-08-19
Completion
2008-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Ospemifene Other / unclassified 30 mg Oral
Subject Ospemifene Other / unclassified 60 mg Oral

Indications