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Evaluate Long-Term Safety and Efficacy WC3011

Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvovaginal Atrophy

Intervention: Estradiol Vaginal Gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Warner Chilcott

Official(s) and/or principal investigator(s):
Herman Ellman, MD, Study Director, Affiliation: Warner Chilcott

Summary

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Clinical Details

Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of WC3011 in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Subjects without Endometrial Hyperplasia or Worse at Visit 7/Final Visit

Secondary outcome:

Change in Subject's Self-Assessment of Intensity of Vaginal Dryness from Baseline to Visit 7/Final Visit

Change in Vaginal Cytology (Maturation Index) from Baseline to Visit 7/Final Visit

Change in Vaginal pH from Baseline to Visit 7/Final Visit

Change in Investigator Assessment of Vulvovaginal Atrophy (VVA) from Baseline to Visit 7/Final Visit

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Completed Study PR-04409

Exclusion Criteria:

- Developed any of the following during Study-PR04409 or has begun taking hormone

therapy other than WC3011:

- Hypersensitivity to estrogen and/or progestin therapy

- Known or suspected premalignant or malignant disease (except successfully treated

skin cancers)

- Manifestation of or treatment for significant cardiovascular disease, stroke or

ischemic attack

- Insulin-dependent diabetes mellitus

- Smoking ≥ 15 cigarettes daily

- Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95

mmHg

Locations and Contacts

Warner Chilcott Investigational Site, Huntsville, Alabama 35801, United States

Warner Chilcott Investigational Site, Mobile, Alabama 36608, United States

Warner Chilcott Investigational Site, Phoenix, Arizona 85015, United States

Warner Chilcott Investigational Site, Phoenix, Arizona 85032, United States

Warner Chilcott Investigational Site, Scottsdale, Arizona 85251, United States

Warner Chilcott Investigational Site, Tucson, Arizona 85710, United States

Warner Chilcott Investigational Site, Tucson, Arizona 85712, United States

Warner Chilcott Investigational Site, San Diego, California 92103, United States

Warner Chilcott Investigational Site, San Diego, California 92108, United States

Warner Chilcott Investigational Site, San Diego, California 92123, United States

Warner Chilcott Investigational Site, Lakewood, Colorado 80228, United States

Warner Chilcott Investigational Site, New London, Connecticut 06320, United States

Warner Chilcott Investigational Site, Washington, District of Columbia 20036, United States

Warner Chilcott Investigational Site, Boynton Beach, Florida 33472, United States

Warner Chilcott Investigational Site, Clearwater, Florida 33759, United States

Warner Chilcott Investigational Site, Jacksonville, Florida 32216, United States

Warner Chilcott Investigational Site, Miami, Florida 33186, United States

Warner Chilcott Investigational Site, Ormond Beach, Florida 32174, United States

Warner Chilcott Investigational Site, Pinellas Park, Florida 33781, United States

Warner Chilcott Investigational Site, South Miami, Florida 33143, United States

Warner Chilcott Investigational Site, West Palm Beach, Florida 33401, United States

Warner Chilcott Investigational Site, West Palm Beach, Florida 33409, United States

Warner Chilcott Investigational Site, Atlanta, Georgia 30342, United States

Warner Chilcott Investigational Site, Decatur, Georgia 30034, United States

Warner Chilcott Investigational Site, Roswell, Georgia 30075, United States

Warner Chilcott Investigational Site, Savannah, Georgia 31406, United States

Warner Chilcott Investigational Site, Chicago, Illinois 60654, United States

Warner Chilcott Investigational Site, Springfield, Illinois 62703, United States

Warner Chilcott Investigational Site, Granger, Indiana 46530, United States

Warner Chilcott Investigational Site, Overland Park, Kansas 66202, United States

Warner Chilcott Investigational Site, Wichita, Kansas 67207, United States

Warner Chilcott Investigational Site, Bardstown, Kentucky 40004, United States

Warner Chilcott Investigational Site, Louisville, Kentucky 40291, United States

Warner Chilcott Investigational Site, Marrero, Louisiana 70072, United States

Warner Chilcott Investigational Site, New Orleans, Louisiana 70115, United States

Warner Chilcott Investigational Site, Kalamazoo, Michigan 49009, United States

Warner Chilcott Investigational Site, Chaska, Minnesota 55318, United States

Warner Chilcott Investigational Site, Las Vegas, Nevada 89106, United States

Warner Chilcott Investigational Site, Lawrenceville, New Jersey 08648, United States

Warner Chilcott Investigational Site, Moorestown, New Jersey 08057, United States

Warner Chilcott Investigational Site, Plainsboro, New Jersey 08536, United States

Warner Chilcott Investigational Site, Greensboro, North Carolina 27408, United States

Warner Chilcott Investigational Site, New Bern, North Carolina 28562, United States

Warner Chilcott Investigational Site, Raleigh, North Carolina 27612, United States

Warner Chilcott Investigational Site, Winston-Salem, North Carolina 27103, United States

Warner Chilcott Investigational Site, Cleveland, Ohio 44122, United States

Warner Chilcott Investigational Site, Columbus, Ohio 43213, United States

Warner Chilcott Investigational Site, Englewood, Ohio 45322, United States

Warner Chilcott Investigational Site, Eugene, Oregon 97401, United States

Warner Chilcott Investigational Site, Medford, Oregon 97504, United States

Warner Chilcott Investigational Site, Jenkintown, Pennsylvania 19046, United States

Warner Chilcott Investigational Site, Philadelphia, Pennsylvania 19114, United States

Warner Chilcott Investigational Site, Pittsburgh, Pennsylvania 15206, United States

Warner Chilcott Investigational Site, Wexford, Pennsylvania 15090, United States

Warner Chilcott Investigational Site, Warwick, Rhode Island 02886, United States

Warner Chilcott Investigational Site, Columbia, South Carolina 29201, United States

Warner Chilcott Investigational Site, Hilton Head Island, South Carolina 29926, United States

Warner Chilcott Investigational Site, Dallas, Texas 75230, United States

Warner Chilcott Investigational Site, Dallas, Texas 75231, United States

Warner Chilcott Investigational Site, Dallas, Texas 75234, United States

Warner Chilcott Investigational Site, Houston, Texas 77030, United States

Warner Chilcott Investigational Site, San Antonio, Texas 78229, United States

Warner Chilcott Investigational Site, Webster, Texas 77598, United States

Warner Chilcott Investigational Site, Salt Lake City, Utah 84109, United States

Warner Chilcott Investigational Site, Salt Lake City, Utah 84121, United States

Warner Chilcott Investigational Site, Sandy, Utah 84070, United States

Warner Chilcott Investigational Site, Norfolk, Virginia 23507, United States

Warner Chilcott Investigational Site, Richmond, Virginia 23233, United States

Warner Chilcott Investigational Site, Seattle, Washington 98105, United States

Warner Chilcott Investigational Site, Spokane, Washington 99207, United States

Warner Chilcott Investigational Site, Tacoma, Washington 98405, United States

Additional Information

Starting date: October 2011
Last updated: February 24, 2015

Page last updated: August 23, 2015

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