Status:
COMPLETED
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Menopause
Postmenopausal Vaginal Atrophy
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00431132
Start Date
January 1 2007
End Date
November 1 2008
Last Update
March 15 2017
Active Locations (42)
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1
Novo Nordisk Investigational Site
Brno, Czechia, 602 00
2
Novo Nordisk Investigational Site
Brno, Czechia, 603 00
3
Novo Nordisk Investigational Site
Olomouc, Czechia, 779 00
4
Novo Nordisk Investigational Site
Prague, Czechia, 128 00