Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Phase 3

Completed

• Conditions: Postmenopausal Vaginal Atrophy; Menopause

• Registration Number: NCT00108849
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-04-19
• Study First Submitted QC: 2005-04-19
• Study First Posted: 2005-04-20
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 309

Inclusion Criteria

• Postmenopausal women whose last menstruation was at least two years previously

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical symptoms	after 12 months

Secondary Outcome Measures

Name	Time	Method
Objective parameters (vaginal Maturation Index/Value and vaginal pH)
Hyperplasia rate

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇦 Winnipeg, Canada