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
45 Years
N/A
Female
Menopause, Postmenopausal Vaginal Atrophy
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Outcome Description:
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.
Outcome Time Frame:
Week 52
Safety Issue:
No
Principal Investigator
Michaela Eugster-Hausmann, MD
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk FemCare AG
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
VAG-1748
NCT ID:
NCT00431132
Start Date:
January 2007
Completion Date:
November 2008
Related Keywords:
- Menopause
- Postmenopausal Vaginal Atrophy
- Vaginitis
- Atrophy
- Adenoma
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