NCT00108849

Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.

Conditions

• Menopause
• Postmenopausal Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	estradiol, 10 mcg

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-04-20
• Last updated: 2017-02-08

Locations

57 sites across 2 countries: United States, Canada