Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

NCT00137371

Last updated date
Study Location
Tucson, Arizona, 85715, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrophic Vaginitis, Atrophy, Vaginitis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Women who do not have a clinical diagnosis of atrophic vaginitis.

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Atrophic Vaginitis, Atrophy, VaginitisStudy Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis NCT00137371
  1. Tucson, Arizona
  2. Encinitas, California
  3. San Diego, California
  4. Torrance, California
  5. Aurora, Colorado
  6. Brooksville, Florida
  7. Miami, Florida
  8. St. Petersburg, Florida
  9. Tampa, Florida
  10. West Palm Beach, Florida
  11. Atlanta, Georgia
  12. Augusta, Georgia
  13. Chicago, Illinois
  14. Metairie, Louisiana
  15. Troy, Michigan
  16. St. Louis, Missouri
  17. Omaha, Nebraska
  18. New Brunswick, New Jersey
  19. Chapel Hill, North Carolina
  20. Winston-Salem, North Carolina
  21. Oklahoma City, Oklahoma
  22. Danville, Pennsylvania
  23. Philadelphia, Pennsylvania
  24. Pittsburgh, Pennsylvania
  25. Carrollton, Texas
  26. Carrollton, Texas
  27. Colleyville, Texas
  28. Dallas, Texas
  29. Houston, Texas
  30. Plano, Texas
  31. Charlottesville, Virginia
  32. Norfolk, Virginia
  33. Calgary, Alberta
  34. Coquitlam, British Columbia
  35. Langley, British Columbia
  36. Winnipeg, Manitoba
  37. Winnipeg, Manitoba
  38. Kingston, Ontario
  39. Ottawa, Ontario
  40. Toronto, Ontario
  41. Toronto, Ontario
  42. Toronto, Ontario
  43. Montreal, Quebec
  44. Montréal, Quebec
  45. Montréal, Quebec
  46. Pointe Claire, Quebec
  47. Québec, Quebec
  48. Shawinigan, Quebec
  49. Sherbrooke, Quebec
Female
45 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
Official Title  ICMJE Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Atrophic Vaginitis
  • Atrophy
  • Vaginitis
Intervention  ICMJE
  • Drug: PVC (daily for 21 days, 7 days off)
  • Drug: PVC (twice weekly)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 25, 2005)
480
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137371
Other Study ID Numbers  ICMJE 0713S5-413
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP