NCT00431132|CompletedPhase 3Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

VAG-17482006-001629-24

Study Type

interventional

Target

336

Locations

7 countries

Sites

Timeline

RegisteredFeb 2007

StartedJan 2007

CompletionNov 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

336

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jan 2007

Geographic Reach

7 countries

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

January 1, 2007

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

April 7, 2011

Completed

Last Updated

March 15, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

February 2, 2007

Results QC Date

February 7, 2011

Last Update Submit

February 6, 2017

Conditions

Menopause Postmenopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
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 Outcomes (1)

Transvaginal Ultrasound: Endometrial Thickness
Week 0, week 52

Study Arms (1)

Vagifem® 10 mcg

EXPERIMENTAL

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

Interventions

estradiol, 10 mcgDRUG

Tablets, administered intravaginally twice weekly

Vagifem® 10 mcg

Eligibility Criteria

Age45 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.