NCT01816139

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 576 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
DRUG	Vehicle	Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks
DRUG	WC3011 Estradiol Vaginal Cream	WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks

Timeline

• Start date: 2013-01-31
• Primary completion: 2013-11-19
• Completion: 2013-11-19
• First posted: 2013-03-21
• Last updated: 2022-05-09
• Results posted: 2022-05-09

Locations

48 sites across 1 country: United States

Regulatory

• FDA-regulated drug study