Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis
1 other identifier
interventional
480
2 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2005
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 10, 2007
December 1, 2007
August 25, 2005
December 7, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
Secondary Outcomes (1)
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who do not have a clinical diagnosis of atrophic vaginitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Unknown Facility
Tucson, Arizona, 85715, United States
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Encinitas, California, 92024, United States
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San Diego, California, 92108, United States
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Torrance, California, 90502, United States
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Aurora, Colorado, 80010, United States
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Brooksville, Florida, 34613, United States
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Miami, Florida, 33186, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33066, United States
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West Palm Beach, Florida, 33407, United States
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Atlanta, Georgia, 30328, United States
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Augusta, Georgia, 30901, United States
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Chicago, Illinois, 60612, United States
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Metairie, Louisiana, 70006, United States
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Troy, Michigan, 48084, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68134, United States
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New Brunswick, New Jersey, 08901, United States
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Chapel Hill, North Carolina, 27514, United States
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Winston-Salem, North Carolina, 27103, United States
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Oklahoma City, Oklahoma, 73112, United States
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Danville, Pennsylvania, 17822-2920, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Carrollton, Texas, 75006, United States
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Carrollton, Texas, 75010, United States
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Colleyville, Texas, 76034, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77030, United States
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Plano, Texas, 75093, United States
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Charlottesville, Virginia, 22903, United States
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Norfolk, Virginia, 23502, United States
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Calgary, Alberta, T2N 4L7, Canada
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Coquitlam, British Columbia, V3K 3V9, Canada
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Langley, British Columbia, V3H 4H9, Canada
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Winnipeg, Manitoba, R3A 1M3, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Ottawa, Ontario, K1H 7W9, Canada
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Toronto, Ontario, M5C 1R6, Canada
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Toronto, Ontario, M5G 1Z5, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Montréal, Quebec, H1T 1P6, Canada
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Montréal, Quebec, H2X 1N8, Canada
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Montreal, Quebec, H3M 3A9, Canada
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Pointe-Claire, Quebec, H9R 4S3, Canada
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Québec, Quebec, G1L 3L5, Canada
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Shawinigan, Quebec, G9N 2H6, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
August 1, 2005
Study Completion
September 1, 2007
Last Updated
December 10, 2007
Record last verified: 2007-12