NCT02670785

A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate Safety and Efficacy of Three Doses of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.

Conditions

• Vulvovaginal Atrophy
• Menopause
• Dyspareunia

Interventions

Type	Name	Description
DRUG	Estradiol Vaginal Capsule (EVC)	Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
DRUG	Placebo	Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Timeline

• Start date: 2016-02-15
• Primary completion: 2016-11-14
• Completion: 2016-11-14
• First posted: 2016-02-02
• Last updated: 2017-08-23

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study