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

Phase

Condition

Severe Premenstrual Symptom

Premenstrual Syndrome

Treatment

N/A

Clinical Study ID

NCT00128934

0858A4-316

Ages 18-49
Female

Study Summary

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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Major depressive disorder requiring antidepressant treatment or hospitalization withinthe last 3 years.
Contraindication to combination oral contraceptives.
Use of antidepressants/anxiolytics within 10 days of screening and for the duration ofthe study. Other exclusions apply.

Study Design

August 01, 2005

December 31, 2007

Connect with a study center

Edmonton, Alberta T6G 2C8
Canada
Site Not Available
Kelowna, British Columbia V1Y 2H4
Canada
Site Not Available
Vancouver, British Columbia V6H 3N1
Canada
Site Not Available
Hamilton, Ontario L8N 4A6
Canada
Site Not Available
Toronto, Ontario M9W 4L6
Canada
Site Not Available
Hull, Quebec J9A 1K7
Canada
Site Not Available
Pointe-Claire, Quebec H9R 4S3
Canada
Site Not Available
Quebec City, Quebec G1R 2W8
Canada
Site Not Available
Shawinigan, Quebec G9N 2H6
Canada
Site Not Available
Sherbrooke, Quebec J1H 4J6
Canada
Site Not Available
Scottsdale, Arizona 85251
United States
Site Not Available
Tucson, Arizona 85715
United States
Site Not Available
Jonesboro, Arkansas 72401
United States
Site Not Available
Little Rock, Arkansas 72205
United States
Site Not Available
Carmichael, California 95608
United States
Site Not Available
Los Angeles, California 90095
United States
Site Not Available
San Diego, California 92103
United States
Site Not Available
Denver, Colorado 80202
United States
Site Not Available
Longmont, Colorado 80501
United States
Site Not Available
Middletown, Connecticut 06457
United States
Site Not Available
New Haven, Connecticut 06510
United States
Site Not Available
Waterbury, Connecticut 06708
United States
Site Not Available
Washington, District of Columbia 20037
United States
Site Not Available
Adventure, Florida 33180
United States
Site Not Available
Clearwater, Florida 33761
United States
Site Not Available
Fort Myers, Florida 33916
United States
Site Not Available
Hialeah, Florida 33016
United States
Site Not Available
Pembroke Pines, Florida 33024
United States
Site Not Available
West Palm Beach, Florida 33407
United States
Site Not Available
Atlanta, Georgia 30342
United States
Site Not Available
Savannah, Georgia 31406
United States
Site Not Available
Boise, Idaho 83712
United States
Site Not Available
Chicago, Illinois 60631
United States
Site Not Available
Evansville, Indiana 47714
United States
Site Not Available
South Bend, Indiana 46601
United States
Site Not Available
Lexington, Kentucky 40509
United States
Site Not Available
New Orleans, Louisiana 70114
United States
Site Not Available
Glen Burnie, Maryland 21061
United States
Site Not Available
Boston, Massachusetts 02114
United States
Site Not Available
Pittsfield, Massachusetts 01201
United States
Site Not Available
Springfield, Massachusetts 01107
United States
Site Not Available
Brooklyn, New York 11235
United States
Site Not Available
Buffalo, New York 14214
United States
Site Not Available
New York City, New York 10021
United States
Site Not Available
Rochester, New York 14609
United States
Site Not Available
Fayetteville, North Carolina 28304
United States
Site Not Available
New Bern, North Carolina 28562
United States
Site Not Available
Winston-Salem, North Carolina 27103
United States
Site Not Available
Cincinnati, Ohio 45219
United States
Site Not Available
Cleveland, Ohio 44122
United States
Site Not Available
Mogadore, Ohio 44260
United States
Site Not Available
Oklahoma City, Oklahoma 73112
United States
Site Not Available
Tulsa, Oklahoma 74135
United States
Site Not Available
Eugene, Oregon 97401
United States
Site Not Available
Medford, Oregon 97504
United States
Site Not Available
Philadelphia, Pennsylvania 19104
United States
Site Not Available
Wexford, Pennsylvania 15090
United States
Site Not Available
East Providence, Rhode Island 02914
United States
Site Not Available
Greer, South Carolina 29654
United States
Site Not Available
Hilton Head Island, South Carolina 29926
United States
Site Not Available
Nashville, Tennessee 37203
United States
Site Not Available
Austin, Texas 78756
United States
Site Not Available
Carrollton, Texas 75010
United States
Site Not Available
Conroe, Texas 77304
United States
Site Not Available
San Antonio, Texas 78229
United States
Site Not Available
Salt Lake City, Utah 84107
United States
Site Not Available
Sandy, Utah 84070
United States
Site Not Available
Burlington, Vermont 05401
United States
Site Not Available
Charlottesville, Virginia 22903
United States
Site Not Available
Norfolk, Virginia 23502
United States
Site Not Available
Richmond, Virginia 23294
United States
Site Not Available
Lakewood, Washington 98499
United States
Site Not Available
Renton, Washington 98055
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.