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

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00128934

Purpose

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	Intervention	Phase
Menstruation Disturbances Premenstrual Syndrome	Drug: levonorgestrel/ethinyl estradiol	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation Premenstrual Syndrome

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	744
Study Start Date:	August 2005
Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128934

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Locations

United States, Arizona

Tucson, Arizona, United States, 85715

Scottsdale, Arizona, United States, 85251
United States, Arkansas

Jonesboro, Arkansas, United States, 72401

Little Rock, Arkansas, United States, 72205
United States, California

San Diego, California, United States, 92103

Los Angeles, California, United States, 90095

Carmichael, California, United States, 95608
United States, Colorado

Lakewood, Colorado, United States, 80228

Longmont, Colorado, United States, 80501

Denver, Colorado, United States, 80202
United States, Connecticut

Waterbury, Connecticut, United States, 06708

Middletown, Connecticut, United States, 06457

New Haven, Connecticut, United States, 06510
United States, District of Columbia

Washington, District of Columbia, United States, 20037
United States, Florida

Hialeah, Florida, United States, 33016

Fort Myers, Florida, United States, 33916

West Palm Beach, Florida, United States, 33407

Pembroke Pines, Florida, United States, 33024

Clearwater, Florida, United States, 33761

Adventure, Florida, United States, 33180
United States, Georgia

Atlanta, Georgia, United States, 30328

Savannah, Georgia, United States, 31406

Atlanta, Georgia, United States, 30342
United States, Idaho

Boise, Idaho, United States, 83712
United States, Illinois

Chicago, Illinois, United States, 60631

Chicago, Illinois, United States, 60634
United States, Indiana

South Bend, Indiana, United States, 46601

Evansville, Indiana, United States, 47714
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

New York City, New York, United States, 10021

Rochester, New York, United States, 14609

Buffalo, New York, United States, 14214

Brooklyn, New York, United States, 11235
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

Cleveland, Ohio, United States, 44122

Cincinnati, Ohio, United States, 45219

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

Wexford, Pennsylvania, United States, 15090

Philadelphia, Pennsylvania, United States, 19114
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

Conroe, Texas, United States, 77304

Austin, Texas, United States, 78756

San Antonio, Texas, United States, 78229

Carrollton, Texas, United States, 75010
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

Richmond, Virginia, United States, 23294

Charlottesville, Virginia, United States, 22903

Richmond, Virginia, United States, 23230

Norfolk, Virginia, United States, 23502

Richmond, Virginia, United States, 23233
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

Toronto, Ontario, Canada, M9W 4L6

Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec

Shawinigan, Quebec, Canada, G9N 2H6

Hull, Quebec, Canada, J9A 1K7

Quebec City, Quebec, Canada, G1R 2W8

Sherbrooke, Quebec, Canada, J1H 4J6

MontrÃ©al, Quebec, Canada, H3A 1A1

Pointe-Claire, Quebec, Canada, H9R 4S3

MontrÃ©al, Quebec, Canada, H1T 1P6

Quebec City, Quebec, Canada, G1S 2L6

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	0858A4-316
Study First Received:	August 8, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00128934 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Wyeth:

Premenstrual Syndrome (PMS)
Hormone Therapy

Additional relevant MeSH terms:

Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Estradiol 17 beta-cypionate
Reproductive Control Agents
Hormones
Pathologic Processes
Menstruation Disturbances
Mental Disorders
Estradiol 3-benzoate

Syndrome
Levonorgestrel
Therapeutic Uses
Contraceptives, Oral, Synthetic
Polyestradiol phosphate
Estrogens
Disease
Ethinyl Estradiol
Depressive Disorder
Estradiol
Pharmacologic Actions
Mood Disorders
Premenstrual Syndrome

ClinicalTrials.gov processed this record on November 27, 2009