Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Condition(s) targeted: Atrophic Vaginitis; Atrophy; Vaginitis

Intervention: PVC (daily for 21 days, 7 days off) (Drug); PVC (twice weekly) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Principal Investigator, Affiliation: Wyeth

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

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.

Calgary, Alberta T2N 4L7, Canada

Tucson, Arizona 85715, United States

Langley, British Columbia V3H 4H9, Canada

Coquitlam, British Columbia V3K 3V9, Canada

Encinitas, California 92024, United States

San Diego, California 92108, United States

Torrance, California 90502, United States

Aurora, Colorado 80010, United States

Miami, Florida 33186, United States

St. Petersburg, Florida 33709, United States

West Palm Beach, Florida 33407, United States

Tampa, Florida 33066, United States

Brooksville, Florida 34613, United States

Atlanta, Georgia 30328, United States

Augusta, Georgia 30901, United States

Chicago, Illinois 60612, United States

Metairie, Louisiana 70006, United States

Winnipeg, Manitoba R3A 1M3, Canada

Winnipeg, Manitoba R3A 1R9, Canada

Troy, Michigan 48084, United States

St. Louis, Missouri 63141, United States

Omaha, Nebraska 68134, United States

New Brunswick, New Jersey 08901, United States

Winston-Salem, North Carolina 27103, United States

Chapel Hill, North Carolina 27514, United States

Oklahoma City, Oklahoma 73112, United States

Toronto, Ontario M9W 4L6, Canada

Toronto, Ontario M5C 1R6, Canada

Kingston, Ontario K7L 2V7, Canada

Ottawa, Ontario K1H 7W9, Canada

Toronto, Ontario M5G 1Z5, Canada

Philadelphia, Pennsylvania 19104, United States

Danville, Pennsylvania 17822-2920, United States

Pittsburgh, Pennsylvania 15206, United States

Shawinigan, Quebec G9N 2H6, Canada

Montréal, Quebec H2X 1N8, Canada

Pointe Claire, Quebec H9R 4S3, Canada

Montréal, Quebec H1T 1P6, Canada

Sherbrooke, Quebec J1H 5N4, Canada

Québec, Quebec G1L 3L5, Canada

Montreal, Quebec H3M 3A9, Canada

Dallas, Texas 75246, United States

Carrollton, Texas 75006, United States

Plano, Texas 75093, United States

Houston, Texas 77030, United States

Carrollton, Texas 75010, United States

Colleyville, Texas 76034, United States

Norfolk, Virginia 23502, United States

Charlottesville, Virginia 22903, United States

Starting date: August 2005
Ending date: September 2007
Last updated: December 7, 2007