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NCT00431132 Clinical Trial

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

Menopause Clinical Trial

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 Vaginitis Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00431132
Other study ID # VAG-1748
Secondary ID 2006-001629-24
Status Completed
Phase Phase 3
First received February 2, 2007
Last updated March 19, 2012
Start date January 2007
Est. completion date November 2008

Study information
Verified date March 2012
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Denmark: Danish Medicines AgencyHungary: National Institute of PharmacyFinland: Finnish Medicines AgencyCzech Republic: State Institute for Drug ControlNorway: Norwegian Medicines AgencySweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 336
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• estradiol, 10 mcg
Tablets, administered intravaginally twice weekly

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Finland,  France,  Hungary,  Norway,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Transvaginal Ultrasound: Endometrial Thickness 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 No
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