Clinical Trial: Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: Clinical symptoms [ Time Frame: after 12 months ]

Original Primary Outcome:

Current Secondary Outcome:

• Objective parameters (vaginal Maturation Index/Value and vaginal pH)
• Hyperplasia rate

Original Secondary Outcome:

Information By: Novo Nordisk A/S

Dates:
Date Received: April 19, 2005
Date Started: March 2005
Date Completion:
Last Updated: February 6, 2017
Last Verified: February 2017