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

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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

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

  • Czech Republic
      • Brno, Czech Republic, 602 00
        • Novo Nordisk Investigational Site
      • Brno, Czech Republic, 603 00
        • Novo Nordisk Investigational Site
      • Olomouc, Czech Republic, 779 00
        • Novo Nordisk Investigational Site
      • Prague, Czech Republic, 128 00
        • Novo Nordisk Investigational Site
      • Prague 5, Czech Republic, 150 00
        • Novo Nordisk Investigational Site
  • Denmark
      • Glostrup, Denmark, 2600
        • Novo Nordisk Investigational Site
      • Herlev, Denmark, 2730
        • Novo Nordisk Investigational Site
      • Hillerød, Denmark, 3400
        • Novo Nordisk Investigational Site
      • Roskilde, Denmark, 4000
        • Novo Nordisk Investigational Site
      • Virum, Denmark, 2830
        • Novo Nordisk Investigational Site
      • Århus N, Denmark, 8200
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, 02100
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70100
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90100
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33101
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20100
        • Novo Nordisk Investigational Site
  • France
      • Evry, France, 91000
        • Novo Nordisk Investigational Site
      • NANTES Cedex 1, France, 44093
        • Novo Nordisk Investigational Site
      • Nimes, France, 30006
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Paris, France, 75005
        • Novo Nordisk Investigational Site
      • Paris, France, 75017
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, H-1034
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, H-1088
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, H-1096
        • Novo Nordisk Investigational Site
      • Pecs, Hungary, H-7624
        • Novo Nordisk Investigational Site
      • Szeged, Hungary, H-6725
        • Novo Nordisk Investigational Site
  • Norway
      • Drammen, Norway, 3015
        • Novo Nordisk Investigational Site
      • Hamar, Norway, NO-2317
        • Novo Nordisk Investigational Site
      • Larvik, Norway
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0264
        • Novo Nordisk Investigational Site
      • Sandvika, Norway, NO-1337
        • Novo Nordisk Investigational Site
      • Ski, Norway, NO-1400
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, NO-4011
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, NO-4020
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, NO-7012
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 416 85
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 411 19
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 582 22
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 217 44
        • Novo Nordisk Investigational Site
      • Norrköping, Sweden, 602 32
        • Novo Nordisk Investigational Site
      • Uppsala, Sweden, 751 85
        • 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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women whose last menstruation was at least two years prior to the time of screening
  • At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
  • Generally healthy

Exclusion Criteria:

  • Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vagifem® 10 mcg
One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
Drug: estradiol, 10 mcg
Tablets, administered intravaginally twice weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Time Frame: Week 52
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transvaginal Ultrasound: Endometrial Thickness
Time Frame: Week 0, week 52
Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.
Week 0, week 52

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

January 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Actual)

March 15, 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-1748
  • 2006-001629-24 (EudraCT Number)

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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