Endometrial Safety of Vagifem Low Dose in Postmenopausal Women With Atrophic Vaginitis
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrophic Vaginitis
Intervention: intravaginal estradiol (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Michaela Eugster-Hausmann, MD, Study Director, Affiliation: Novo Nordisk FemCare AG
Summary
This trial is conducted in Europe.
The purpose of this study is to evaluate endometrial safety of Vagifem Low dose in healthy
postmenopausal women having atropic vaginitis.
Clinical Details
Official title: Endometrial Safety of Vagifem Low Dose in Postmenopausal Women With Atrophic Vaginitis
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Endometrial hyperplasia rate based on histological assessment of endometrial biopsies
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women whose last menstruation was at least two years previously
- 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
Locations and Contacts
Prague, Czech Republic
Glostrup, Denmark
Turku, Finland
PARIS, France
Budapest, Hungary
Trondheim, Norway
Uppsala, Sweden
Additional Information
Clinical Trials at Novo Nordisk
Starting date: January 2007
Ending date: January 2009
Last updated: February 13, 2008
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