NCT00431132

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Conditions

• Menopause
• Postmenopausal Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	estradiol, 10 mcg	Tablets, administered intravaginally twice weekly

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-02-05
• Last updated: 2017-03-15
• Results posted: 2011-04-07

Locations

42 sites across 7 countries: Czechia, Denmark, Finland, France, Hungary, Norway, Sweden