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Trial record 99 of 403 for:    LEVONORGESTREL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128934
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : December 27, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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).

Condition or disease Intervention/treatment Phase
Menstruation Disturbances Premenstrual Syndrome Drug: levonorgestrel/ethinyl estradiol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : August 2005
Actual Study Completion Date : December 2007

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128934

  Hide Study Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85251
Tucson, Arizona, United States, 85715
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Carmichael, California, United States, 95608
Los Angeles, California, United States, 90095
San Diego, California, United States, 92103
United States, Colorado
Denver, Colorado, United States, 80202
Lakewood, Colorado, United States, 80228
Longmont, Colorado, United States, 80501
United States, Connecticut
Middletown, Connecticut, United States, 06457
New Haven, Connecticut, United States, 06510
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Florida
Adventure, Florida, United States, 33180
Clearwater, Florida, United States, 33761
Fort Myers, Florida, United States, 33916
Hialeah, Florida, United States, 33016
Pembroke Pines, Florida, United States, 33024
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta, Georgia, United States, 30328
Atlanta, Georgia, United States, 30342
Savannah, Georgia, United States, 31406
United States, Idaho
Boise, Idaho, United States, 83712
United States, Illinois
Chicago, Illinois, United States, 60631
Chicago, Illinois, United States, 60634
United States, Indiana
Evansville, Indiana, United States, 47714
South Bend, Indiana, United States, 46601
United States, Kentucky
Lexington, Kentucky, United States, 40509
United States, Louisiana
New Orleans, Louisiana, United States, 70114
United States, Maryland
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Pittsfield, Massachusetts, United States, 01201
Springfield, Massachusetts, United States, 01107
United States, New York
Brooklyn, New York, United States, 11235
Buffalo, New York, United States, 14214
New York City, New York, United States, 10021
Rochester, New York, United States, 14609
United States, North Carolina
Fayetteville, North Carolina, United States, 28304
New Bern, North Carolina, United States, 28562
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44122
Mogadore, Ohio, United States, 44260
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Eugene, Oregon, United States, 97401
Medford, Oregon, United States, 97504
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19114
Wexford, Pennsylvania, United States, 15090
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Greer, South Carolina, United States, 29654
Hilton Head Island, South Carolina, United States, 29926
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78756
Carrollton, Texas, United States, 75010
Conroe, Texas, United States, 77304
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84107
Sandy, Utah, United States, 84070
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Charlottesville, Virginia, United States, 22903
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23230
Richmond, Virginia, United States, 23233
Richmond, Virginia, United States, 23294
United States, Washington
Lakewood, Washington, United States, 98499
Renton, Washington, United States, 98055
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2C8
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 2H4
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Hull, Quebec, Canada, J9A 1K7
Montréal, Quebec, Canada, H1T 1P6
Montréal, Quebec, Canada, H3A 1A1
Pointe-Claire, Quebec, Canada, H9R 4S3
Quebec City, Quebec, Canada, G1R 2W8
Quebec City, Quebec, Canada, G1S 2L6
Shawinigan, Quebec, Canada, G9N 2H6
Sherbrooke, Quebec, Canada, J1H 4J6
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00128934     History of Changes
Obsolete Identifiers: NCT00278720
Other Study ID Numbers: 0858A4-316
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Premenstrual Syndrome (PMS)
Hormone Therapy
Additional relevant MeSH terms:
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Premenstrual Syndrome
Premenstrual Dysphoric Disorder
Menstruation Disturbances
Pathologic Processes
Depressive Disorder
Mood Disorders
Mental Disorders
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral