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

Phase 3

Completed

• Conditions: Postmenopausal Vaginal Atrophy; Menopause
• Interventions: Drug: estradiol, 10 mcg

• Registration Number: NCT00431132
• Lead Sponsor: Novo Nordisk A/S

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 Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-02
• Study First Submitted QC: 2007-02-02
• Study First Posted: 2007-02-05
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2011-02-07
• Results First Submitted QC: 2011-03-07
• Results First Posted: 2011-04-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 336

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vagifem® 10 mcg	estradiol, 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

Primary Outcome Measures

Name	Time	Method
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies	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.

Secondary Outcome Measures

Name	Time	Method
Transvaginal Ultrasound: Endometrial Thickness	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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Uppsala, Sweden