NCT01400776

Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 722 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Conditions

• Postmenopausal Vulvovaginal Atrophy

Interventions

Type	Name	Description
DRUG	WC3011 Estradiol Vaginal Cream	WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
DRUG	Vehicle	Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

Timeline

• Start date: 2011-06-29
• Primary completion: 2012-02-27
• Completion: 2012-02-27
• First posted: 2011-07-22
• Last updated: 2022-05-09
• Results posted: 2022-05-09

Locations

70 sites across 1 country: United States

Regulatory

• FDA-regulated drug study