Back to resultsStudy Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
Primary Purpose
Atrophic Vaginitis, Atrophy, Vaginitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PVC (daily for 21 days, 7 days off)
PVC (twice weekly)
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Vaginitis focused on measuring Postmenopause, Vaginitis
Eligibility Criteria
Inclusion Criteria: Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse. The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus. Exclusion Criteria: Women who do not have a clinical diagnosis of atrophic vaginitis.
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
Secondary Outcome Measures
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
Full Information
NCT ID
NCT00137371
First Posted
August 25, 2005
Last Updated
December 7, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00137371
Brief Title
Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
Official Title
Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis, Atrophy, Vaginitis
Keywords
Postmenopause, Vaginitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PVC (daily for 21 days, 7 days off)
Intervention Type
Drug
Intervention Name(s)
PVC (twice weekly)
Primary Outcome Measure Information:
Title
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
Secondary Outcome Measure Information:
Title
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse.
The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.
Exclusion Criteria:
Women who do not have a clinical diagnosis of atrophic vaginitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Principal Investigator
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33066
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2920
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4L7
Country
Canada
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3V9
Country
Canada
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3H 4H9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3M 3A9
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1P6
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1L 3L5
Country
Canada
City
Shawinigan
State/Province
Quebec
ZIP/Postal Code
G9N 2H6
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
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Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
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