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Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis - Article


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Clinical Trial: Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

This study is currently recruiting patients.
Verified by Wyeth August 2005

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00137371

Purpose

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.
Condition Intervention Phase
Atrophic Vaginitis
  Drug: PVC daily for 21 days, 7 days off
 Drug: Placebo cream daily for 21 days, 7 days off
 Drug: PVC twice weekly
 Drug: Placebo cream twice weekly
 Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis

Further Study Details: 
Primary Outcomes: 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: To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimuation and genital health.
Expected Total Enrollment:  480

Study start: August 2005

Eligibility

Ages Eligible for Study:  45 Years   -   80 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00137371

Trial Manager       clinicaltrialinfo@wyeth.com

Arizona
      Tucson,  Arizona,  85715,  United States; Not yet recruiting
  see Central Contact 

California
      Encinitas,  California,  92024,  United States; Recruiting
  see Central Contact 

      San Diego,  California,  92108,  United States; Not yet recruiting
  see Central Contact 

      Torrance,  California,  90509,  United States; Not yet recruiting
  see Central Contact 

Colorado
      Aurora,  Colorado,  80010,  United States; Not yet recruiting
  see Central Contact 

Florida
      Miami,  Florida,  33186,  United States; Not yet recruiting
  see Central Contact 

      St. Petersburg,  Florida,  33709,  United States; Not yet recruiting
  see Central Contact 

      West Palm Beach,  Florida,  33407,  United States; Not yet recruiting
  see Central Contact 

      Tampa,  Florida,  33066,  United States; Not yet recruiting
  see Central Contact 

Georgia
      Atlanta,  Georgia,  30328,  United States; Not yet recruiting
  see Central Contact 

      Augusta,  Georgia,  30901,  United States; Not yet recruiting
  see Central Contact 

      Atlanta,  Georgia,  30328,  United States; Not yet recruiting
  see Central Contact 

Illinois
      Chicago,  Illinois,  60612,  United States; Not yet recruiting
  see Central Contact 

Louisiana
      Metairie,  Louisiana,  70006,  United States; Not yet recruiting
  see Central Contact 

Michigan
      Detroit,  Michigan,  48202,  United States; Not yet recruiting
  see Central Contact 

Missouri
      St. Louis,  Missouri,  63141,  United States; Not yet recruiting
  see Central Contact 

Nebraska
      Omaha,  Nebraska,  68134,  United States; Not yet recruiting
  see Central Contact 

New Jersey
      New Brunswick,  New Jersey,  08901,  United States; Not yet recruiting
  see Central Contact 

North Carolina
      Winston Salem,  North Carolina,  27103,  United States; Not yet recruiting
  see Central Contact 

      Chapel Hill,  North Carolina,  27599,  United States; Not yet recruiting
  see Central Contact 

Oklahoma
      Oklahoma City,  Oklahoma,  73112,  United States; Not yet recruiting
  see Central Contact 

Pennsylvania
      Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
  see Central Contact 

      Danville,  Pennsylvania,  17822-2920,  United States; Not yet recruiting
  see Central Contact 

      Pittsburgh,  Pennsylvania,  15206,  United States; Not yet recruiting
  see Central Contact 

Texas
      Dallas,  Texas,  75246,  United States; Not yet recruiting
  see Central Contact 

      Carrollton,  Texas,  75006,  United States; Not yet recruiting
  see Central Contact 

      Plano,  Texas,  75093,  United States; Not yet recruiting
  see Central Contact 

      Houston,  Texas,  77030,  United States; Not yet recruiting
  see Central Contact 

      Carrollton,  Texas,  75010,  United States; Not yet recruiting
  see Central Contact 

      Colleyville,  Texas,  76034,  United States; Not yet recruiting
  see Central Contact 

Virginia
      Norfolk,  Virginia,  23502,  United States; Not yet recruiting
  see Central Contact 

      Charlottesville,  Virginia,  22903,  United States; Not yet recruiting
  see Central Contact 

Canada, Alberta
      Calgary,  Alberta,  T2N 4L7,  Canada; Not yet recruiting
  see Central Contact 

Canada, British Columbia
      Langley,  British Columbia,  V3H 4H9,  Canada; Not yet recruiting
  see Central Contact 

      Coquitlam,  British Columbia,  V3K 3V9,  Canada; Not yet recruiting
  see Central Contact 

Canada, Manitoba
      Winnipeg,  Manitoba,  R3A 1M3,  Canada; Not yet recruiting
  see Central Contact 

      Winnipeg,  Manitoba,  R3A 1R9,  Canada; Not yet recruiting
  see Central Contact 

Canada, Ontario
      Toronto,  Ontario,  M9W 4L6,  Canada; Not yet recruiting
  see Central Contact 

      Toronto,  Ontario,  M5C 1R6,  Canada; Not yet recruiting
  see Central Contact 

      Kingston,  Ontario,  K7L 2V7,  Canada; Not yet recruiting
  see Central Contact 

      Ottawa,  Ontario,  K1H 7W9,  Canada; Not yet recruiting
  see Central Contact 

      Toronto,  Ontario,  M5G 1Z5,  Canada; Not yet recruiting
  see Central Contact 

Canada, Quebec
      Shawinigan,  Quebec,  G9N 2H6,  Canada; Not yet recruiting
  see Central Contact 

      Montréal,  Quebec,  H2X 1N8,  Canada; Not yet recruiting
  see Central Contact 

      Pointe-Claire,  Quebec,  H9R 4S3,  Canada; Not yet recruiting
  see Central Contact 

      Montréal,  Quebec,  H1T 1P6,  Canada; Not yet recruiting
  see Central Contact 

      Sherbrooke,  Quebec,  J1H 5N4,  Canada; Not yet recruiting
  see Central Contact 

      Québec,  Quebec,  G1L 3L5,  Canada; Not yet recruiting
  see Central Contact 

      Montreal,  Quebec,  H3M 3A9,  Canada; Not yet recruiting
  see Central Contact 

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

More Information

Study ID Numbers:  0713S5-413
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00137371
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30


Source: ClinicalTrials.gov
Cache Date: August 31, 2005

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