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

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.

Study Overview

• Status: Completed
• Conditions: Atrophy; Vaginitis; Atrophic Vaginitis
• Intervention / Treatment: Drug: PVC (daily for 21 days, 7 days off); Drug: PVC (twice weekly)

• Study Type: Interventional
• Enrollment: 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4L7
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3V9
    • Langley, British Columbia, Canada, V3H 4H9
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
    • Winnipeg, Manitoba, Canada, R3A 1R9
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
    • Ottawa, Ontario, Canada, K1H 7W9
    • Toronto, Ontario, Canada, M5C 1R6
    • Toronto, Ontario, Canada, M5G 1Z5
    • Toronto, Ontario, Canada, M9W 4L6
  • Quebec
    • Montreal, Quebec, Canada, H3M 3A9
    • Montréal, Quebec, Canada, H1T 1P6
    • Montréal, Quebec, Canada, H2X 1N8
    • Pointe Claire, Quebec, Canada, H9R 4S3
    • Québec, Quebec, Canada, G1L 3L5
    • Shawinigan, Quebec, Canada, G9N 2H6
    • Sherbrooke, Quebec, Canada, J1H 5N4
• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
  • California
    • Encinitas, California, United States, 92024
    • San Diego, California, United States, 92108
    • Torrance, California, United States, 90502
  • Colorado
    • Aurora, Colorado, United States, 80010
  • Florida
    • Brooksville, Florida, United States, 34613
    • Miami, Florida, United States, 33186
    • St. Petersburg, Florida, United States, 33709
    • Tampa, Florida, United States, 33066
    • West Palm Beach, Florida, United States, 33407
  • Georgia
    • Atlanta, Georgia, United States, 30328
    • Augusta, Georgia, United States, 30901
  • Illinois
    • Chicago, Illinois, United States, 60612
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • Michigan
    • Troy, Michigan, United States, 48084
  • Missouri
    • St. Louis, Missouri, United States, 63141
  • Nebraska
    • Omaha, Nebraska, United States, 68134
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
    • Winston-Salem, North Carolina, United States, 27103
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2920
    • Philadelphia, Pennsylvania, United States, 19104
    • Pittsburgh, Pennsylvania, United States, 15206
  • Texas
    • Carrollton, Texas, United States, 75006
    • Carrollton, Texas, United States, 75010
    • Colleyville, Texas, United States, 76034
    • Dallas, Texas, United States, 75246
    • Houston, Texas, United States, 77030
    • Plano, Texas, United States, 75093
  • Virginia
    • Charlottesville, Virginia, United States, 22903
    • Norfolk, Virginia, United States, 23502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion: December 7, 2022
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: August 25, 2005
• First Submitted That Met QC Criteria: August 25, 2005
• First Posted (Estimate): August 29, 2005

Study Record Updates

• Last Update Posted (Estimate): December 10, 2007
• Last Update Submitted That Met QC Criteria: December 7, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Postmenopause; Vaginitis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Vaginal Diseases; Vaginitis; Atrophic Vaginitis; Atrophy
• Other Study ID Numbers: 0713S5-413

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No