NCT01845649

Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia

A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
DRUG	WC3011 Estradiol Vaginal Cream	Daily for 14 days followed by 3 times per week for 10 weeks
DRUG	Vehicle	Daily for 14 days followed by 3 times per week for 10 weeks

Timeline

• Start date: 2013-04-12
• Primary completion: 2013-11-20
• Completion: 2013-11-20
• First posted: 2013-05-03
• Last updated: 2022-05-09
• Results posted: 2022-05-09

Locations

57 sites across 1 country: United States