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

• ClinicalTrials.gov Identifier: NCT00161681
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Last Update Posted: February 8, 2013
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Wyeth is now a wholly owned subsidiary of Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Premenstrual Syndrome	Drug: Levonorgestrel/Ethinyl Estradiol	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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 Start Date: July 2005
• Actual Primary Completion Date: August 2006
• Actual Study Completion Date: August 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes 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

Locations

United States, Alabama

Huntsville, Alabama, United States, 35801

United States, Arizona

Peoria, Arizona, United States, 85381

Phoenix, Arizona, United States, 85031

Phoenix, Arizona, United States, 85032

Tucson, Arizona, United States, 85715

United States, California

San Diego, California, United States, 92103

United States, Colorado

Denver, Colorado, United States, 80202

Longmont, Colorado, United States, 80501

United States, Florida

Aventura, Florida, United States, 33180

Boynton Beach, Florida, United States, 33437

Clearwater, Florida, United States, 33761

Deland, Florida, United States, 32720

Fort Myers, Florida, United States, 33916

Miami, Florida, United States, 33143

Miami, Florida, United States, 33186

Pembroke Pines, Florida, United States, 33024

Tampa, Florida, United States, 33607

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

Idaho Falls, Idaho, United States, 83404

United States, Illinois

Chicago, Illinois, United States, 60612

Chicago, Illinois, United States, 60631

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

Cleveland, Ohio, United States, 44122

Mogadore, Ohio, United States, 44260

United States, Oregon

Eugene, Oregon, United States, 97401

Medford, Oregon, United States, 97504

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Pittsburgh, Pennsylvania, United States, 15206

Wexford, Pennsylvania, United States, 15090

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

Lakewood, Washington, United States, 98499

Seattle, Washington, United States, 98105

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, MD; Wyeth is now a wholly owned subsidiary of Pfizer

More Information

• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• ClinicalTrials.gov Identifier: NCT00161681
• Other Study ID Numbers: 0858A2-322; B3121024 ( Other Identifier: Pfizer )
• First Posted: September 12, 2005
• Last Update Posted: February 8, 2013
• Last Verified: May 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Levonorgestrel; ethinyl estradiol; premenstrual syndrome; menstrual cycle related symptoms

Additional relevant MeSH terms:

Premenstrual Syndrome; Pathologic Processes; Menstruation Disturbances; Levonorgestrel; Ethinyl Estradiol; Estradiol; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral; Contraceptives, Oral, Hormonal