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

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

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: 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.


Original Primary Outcome: Endometrial hyperplasia rate based on histological assessment of endometrial biopsies taken at the end of 12 months of treatment with Vagifem Low dose compared to baseline

Current Secondary Outcome: 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.


Original Secondary Outcome:

Information By: Novo Nordisk A/S

Dates:
Date Received: February 2, 2007
Date Started: January 2007
Date Completion:
Last Updated: February 6, 2017
Last Verified: February 2017