Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00161681

Purpose

The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.

Condition	Intervention	Phase
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 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms

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:

To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo

Secondary Outcome Measures:

To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo

Estimated Enrollment:	200
Study Start Date:	August 2005

Eligibility

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

Criteria

Inclusion Criteria:

Healthy women aged 18 to 49 years
Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
History of menstrual cycle related symptoms as determined by the investigator.

Exclusion Criteria:

Contraindication to combination oral contraceptives
Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161681

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Locations

United States, Alabama

Huntsville, Alabama, United States, 35801
United States, Arizona

Tucson, Arizona, United States, 85715

Phoenix, Arizona, United States, 85031

Phoenix, Arizona, United States, 85032

Peoria, Arizona, United States, 85381
United States, California

San Diego, California, United States, 92103
United States, Colorado

Longmont, Colorado, United States, 80501

Denver, Colorado, United States, 80202
United States, Florida

Boynton Beach, Florida, United States, 33437

Miami, Florida, United States, 33143

Miami, Florida, United States, 33186

Aventura, Florida, United States, 33180

West Palm Beach, Florida, United States, 33407

Pembroke Pines, Florida, United States, 33024

Deland, Florida, United States, 32720

Clearwater, Florida, United States, 33761

Tampa, Florida, United States, 33607

Fort Myers, Florida, United States, 33916
United States, Georgia

Atlanta, Georgia, United States, 30328

Atlanta, Georgia, United States, 30342

Savannah, Georgia, United States, 31406
United States, Idaho

Idaho Falls, Idaho, United States, 83404
United States, Illinois

Chicago, Illinois, United States, 60631

Chicago, Illinois, United States, 60612
United States, Kentucky

Lexington, Kentucky, United States, 40509
United States, Missouri

Kansas City, Missouri, United States, 64114
United States, Nevada

Las Vegas, Nevada, United States, 89109

Las Vegas, Nevada, United States, 89118
United States, New Jersey

Moorestown, New Jersey, United States, 08057
United States, New York

Rochester, New York, United States, 14609
United States, North Carolina

Fayetteville, North Carolina, United States, 28304

Winston-Salem, North Carolina, United States, 27103
United States, Ohio

Mogadore, Ohio, United States, 44260

Cleveland, Ohio, United States, 44122
United States, Oregon

Eugene, Oregon, United States, 97401

Medford, Oregon, United States, 97504
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15206

Wexford, Pennsylvania, United States, 15090

Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina

Hilton Head Island, South Carolina, United States, 29926

Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee

Nashville, Tennessee, United States, 37203
United States, Texas

Houston, Texas, United States, 77024

San Antonio, Texas, United States, 78229
United States, Utah

Sandy, Utah, United States, 84070
United States, Virginia

Richmond, Virginia, United States, 23226
United States, Washington

Seattle, Washington, United States, 98105

Lakewood, Washington, United States, 98499

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	0858A2-322
Study First Received:	September 7, 2005
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00161681 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Levonorgestrel
ethinyl estradiol
premenstrual syndrome
menstrual cycle related symptoms

Additional relevant MeSH terms:

Estrogens
Disease
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Reproductive Control Agents
Estradiol 17 beta-cypionate
Hormones

Pharmacologic Actions
Estradiol
Pathologic Processes
Menstruation Disturbances
Therapeutic Uses
Syndrome
Estradiol 3-benzoate
Levonorgestrel
Contraceptives, Oral, Synthetic
Polyestradiol phosphate
Premenstrual Syndrome

ClinicalTrials.gov processed this record on November 27, 2009