Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaginitis
Intervention: intravaginal estradiol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Alan Moses, MD, Study Director, Affiliation: Novo Nordisk
Summary
This trial is conducted in North America.
The purpose of this study is to determine if Vagifem Low Dose is an effective and safe
treatment for patients suffering from postmenopausal atrophic vaginitis.
Clinical Details
Official title: Efficacy and Safety of Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical symptoms
Secondary outcome: Objective parameters (vaginal Maturation Index/Value and vaginal pH)Hyperplasia rate
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women = 2 years after last menstruation
Locations and Contacts
Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89103, United States
Additional Information
Clinical Trials at Novo Nordisk
Starting date: March 2005
Last updated: August 30, 2007
|
