Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

Condition(s) targeted: Menstruation Disturbances; Premenstrual Syndrome

Intervention: levonorgestrel/ethinyl estradiol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth

The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder

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

Primary outcome: Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Secondary outcome: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Generally healthy, women aged 18 to 49 years.

- History of severe PMS symptoms over the last year, as determined by the investigator.

- Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.

Exclusion Criteria:

- Major depressive disorder requiring antidepressant treatment or hospitalization within

the last 3 years.

- Contraindication to combination oral contraceptives.

- Use of antidepressants/anxiolytics within 10 days of screening and for the duration of

the study.

Other exclusions apply.

Edmonton, Alberta T6G 2C8, Canada

Edmonton, Alberta T6L 5X8, Canada

Tucson, Arizona 85715, United States

Scottsdale, Arizona 85251, United States

Jonesboro, Arkansas 72401, United States

Little Rock, Arkansas 72205, United States

Kelowna, British Columbia V1Y 2H4, Canada

Vancouver, British Columbia V6H 3N1, Canada

San Diego, California 92103, United States

Los Angeles, California 90095, United States

Carmichael, California 95608, United States

Lakewood, Colorado 80228, United States

Longmont, Colorado 80501, United States

Denver, Colorado 80202, United States

Waterbury, Connecticut 06708, United States

Middletown, Connecticut 06457, United States

New Haven, Connecticut 06510, United States

Washington, District of Columbia 20037, United States

Hialeah, Florida 33016, United States

Adventure, Florida 33180, United States

West Palm Beach, Florida 33407, United States

Pembroke Pines, Florida 33024, United States

Clearwater, Florida 33761, United States

Fort Myers, Florida 33916, United States

Atlanta, Georgia 30328, United States

Savannah, Georgia 31406, United States

Atlanta, Georgia 30342, United States

Boise, Idaho 83712, United States

Chicago, Illinois 60631, United States

Chicago, Illinois 60634, United States

South Bend, Indiana 46601, United States

Evansville, Indiana 47714, United States

Lexington, Kentucky 40509, United States

New Orleans, Louisiana 70114, United States

Glen Burnie, Maryland 21061, United States

Boston, Massachusetts 02114, United States

Pittsfield, Massachusetts 01201, United States

Springfield, Massachusetts 01107, United States

New York City, New York 10021, United States

Rochester, New York 14609, United States

Buffalo, New York 14214, United States

Brooklyn, New York 11235, United States

Fayetteville, North Carolina 28304, United States

New Bern, North Carolina 28562, United States

Winston-Salem, North Carolina 27103, United States

Cleveland, Ohio 44122, United States

Cincinnati, Ohio 45219, United States

Mogadore, Ohio 44260, United States

Oklahoma City, Oklahoma 73112, United States

Tulsa, Oklahoma 74135, United States

Toronto, Ontario M9W 4L6, Canada

Hamilton, Ontario L8N 4A6, Canada

Eugene, Oregon 97401, United States

Medford, Oregon 97504, United States

Philadelphia, Pennsylvania 19104, United States

Wexford, Pennsylvania 15090, United States

Philadelphia, Pennsylvania 19114, United States

Shawinigan, Quebec G9N 2H6, Canada

Hull, Quebec J9A 1K7, Canada

Quebec City, Quebec G1R 2W8, Canada

Quebec City, Quebec G1S 2L6, Canada

Montréal, Quebec H3A 1A1, Canada

Pointe-Claire, Quebec H9R 4S3, Canada

Montréal, Quebec H1T 1P6, Canada

Sherbrooke, Quebec J1H 4J6, Canada

East Providence, Rhode Island 02914, United States

Greer, South Carolina 29654, United States

Hilton Head Island, South Carolina 29926, United States

Nashville, Tennessee 37203, United States

Conroe, Texas 77304, United States

Austin, Texas 78756, United States

San Antonio, Texas 78229, United States

Carrollton, Texas 75010, United States

Salt Lake City, Utah 84107, United States

Sandy, Utah 84070, United States

Burlington, Vermont 05401, United States

Richmond, Virginia 23294, United States

Charlottesville, Virginia 22903, United States

Richmond, Virginia 23230, United States

Norfolk, Virginia 23502, United States

Richmond, Virginia 23233, United States

Lakewood, Washington 98499, United States

Renton, Washington 98055, United States

Starting date: August 2005
Ending date: December 2007
Last updated: December 18, 2007