Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

Condition(s) targeted: 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 LNG/EE is effective in the treatment of menstrual cycle related symptoms.

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

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

Primary outcome: 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: 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

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

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.

Huntsville, Alabama 35801, United States

Tucson, Arizona 85715, United States

Phoenix, Arizona 85031, United States

Phoenix, Arizona 85032, United States

Peoria, Arizona 85381, United States

San Diego, California 92103, United States

Longmont, Colorado 80501, United States

Denver, Colorado 80202, United States

Boynton Beach, Florida 33437, United States

Miami, Florida 33143, United States

Miami, Florida 33186, United States

Aventura, Florida 33180, United States

West Palm Beach, Florida 33407, United States

Pembroke Pines, Florida 33024, United States

Deland, Florida 32720, United States

Clearwater, Florida 33761, United States

Tampa, Florida 33607, United States

Fort Myers, Florida 33916, United States

Atlanta, Georgia 30328, United States

Atlanta, Georgia 30342, United States

Savannah, Georgia 31406, United States

Idaho Falls, Idaho 83404, United States

Chicago, Illinois 60631, United States

Chicago, Illinois 60612, United States

Lexington, Kentucky 40509, United States

Kansas City, Missouri 64114, United States

Las Vegas, Nevada 89109, United States

Las Vegas, Nevada 89118, United States

Moorestown, New Jersey 08057, United States

Rochester, New York 14609, United States

Fayetteville, North Carolina 28304, United States

Winston-Salem, North Carolina 27103, United States

Mogadore, Ohio 44260, United States

Cleveland, Ohio 44122, United States

Eugene, Oregon 97401, United States

Medford, Oregon 97504, United States

Pittsburgh, Pennsylvania 15206, United States

Wexford, Pennsylvania 15090, United States

Philadelphia, Pennsylvania 19104, United States

Hilton Head Island, South Carolina 29926, United States

Mt. Pleasant, South Carolina 29464, United States

Nashville, Tennessee 37203, United States

Houston, Texas 77024, United States

San Antonio, Texas 78229, United States

Sandy, Utah 84070, United States

Richmond, Virginia 23226, United States

Seattle, Washington 98105, United States

Lakewood, Washington 98499, United States

Starting date: August 2005
Last updated: May 25, 2007