Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

NCT ID: NCT00137371

Last Updated: 2007-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrophic Vaginitis Atrophy Vaginitis

Keywords

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Postmenopause Vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PVC (daily for 21 days, 7 days off)

Intervention Type DRUG

PVC (twice weekly)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: PRINCIPAL_INVESTIGATOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Tucson, Arizona, United States

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Encinitas, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Brooksville, Florida, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Metairie, Louisiana, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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New Brunswick, New Jersey, United States

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Chapel Hill, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Danville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Carrollton, Texas, United States

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Carrollton, Texas, United States

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Colleyville, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Calgary, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Langley, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Kingston, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montréal, Quebec, Canada

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Montréal, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Shawinigan, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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0713S5-413

Identifier Type: -

Identifier Source: org_study_id