Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

February 6, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Kingston, Canada, K7L 4P8
        • Novo Nordisk Investigational Site
      • Montreal, Canada, H1T 1P6
        • Novo Nordisk Investigational Site
      • Quebec City, Canada, G1S 2L6
        • Novo Nordisk Investigational Site
      • Toronto, Canada, M5C 1R6
        • Novo Nordisk Investigational Site
      • Toronto, Canada, M5G 1Z5
        • Novo Nordisk Investigational Site
      • Winnipeg, Canada, R3A 1M3
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Novo Nordisk Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Novo Nordisk Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85712
        • Novo Nordisk Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Novo Nordisk Investigational Site
      • Palo Alto, California, United States, 94304
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92123
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92108
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
      • Denver, Colorado, United States, 80218
        • Novo Nordisk Investigational Site
      • Lakewood, Colorado, United States, 80228
        • Novo Nordisk Investigational Site
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33759
        • Novo Nordisk Investigational Site
      • Daytona Beach, Florida, United States, 32114
        • Novo Nordisk Investigational Site
      • Palm Springs, Florida, United States, 33461
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Novo Nordisk Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30075
        • Novo Nordisk Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Novo Nordisk Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Novo Nordisk Investigational Site
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Novo Nordisk Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
      • Moorestown, New Jersey, United States, 08057
        • Novo Nordisk Investigational Site
    • New York
      • New York City, New York, United States, 10016
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Novo Nordisk Investigational Site
      • Mount Airy, North Carolina, United States, 27030
        • Novo Nordisk Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43210
        • Novo Nordisk Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Novo Nordisk Investigational Site
      • Medford, Oregon, United States, 97504
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Novo Nordisk Investigational Site
      • West Reading, Pennsylvania, United States, 19611
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Novo Nordisk Investigational Site
      • Columbia, South Carolina, United States, 29201
        • Novo Nordisk Investigational Site
      • Greenville, South Carolina, United States, 29607
        • Novo Nordisk Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Novo Nordisk Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
    • Utah
      • Sandy, Utah, United States, 84070
        • Novo Nordisk Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99207
        • Novo Nordisk Investigational Site
      • Tacoma, Washington, United States, 98405
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical symptoms
Time Frame: after 12 months
after 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

April 19, 2005

First Submitted That Met QC Criteria

April 19, 2005

First Posted (Estimate)

April 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAG-2195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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