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

December 18, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

744

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6L 5X8
      • Edmonton, Alberta, Canada, T6G 2C8
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
      • Vancouver, British Columbia, Canada, V6H 3N1
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • Toronto, Ontario, Canada, M9W 4L6
    • 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
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
      • Tucson, Arizona, United States, 85715
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
    • California
      • Carmichael, California, United States, 95608
      • Los Angeles, California, United States, 90095
      • San Diego, California, United States, 92103
    • Colorado
      • Denver, Colorado, United States, 80202
      • Lakewood, Colorado, United States, 80228
      • Longmont, Colorado, United States, 80501
    • Connecticut
      • Middletown, Connecticut, United States, 06457
      • New Haven, Connecticut, United States, 06510
      • Waterbury, Connecticut, United States, 06708
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • 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
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30328
      • Savannah, Georgia, United States, 31406
    • Idaho
      • Boise, Idaho, United States, 83712
    • Illinois
      • Chicago, Illinois, United States, 60631
      • Chicago, Illinois, United States, 60634
    • Indiana
      • Evansville, Indiana, United States, 47714
      • South Bend, Indiana, United States, 46601
    • Kentucky
      • Lexington, Kentucky, United States, 40509
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Pittsfield, Massachusetts, United States, 01201
      • Springfield, Massachusetts, United States, 01107
    • 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
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
      • New Bern, North Carolina, United States, 28562
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44122
      • Mogadore, Ohio, United States, 44260
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Tulsa, Oklahoma, United States, 74135
    • Oregon
      • Eugene, Oregon, United States, 97401
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19114
      • Wexford, Pennsylvania, United States, 15090
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
    • South Carolina
      • Greer, South Carolina, United States, 29654
      • Hilton Head Island, South Carolina, United States, 29926
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78756
      • Carrollton, Texas, United States, 75010
      • Conroe, Texas, United States, 77304
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84107
      • Sandy, Utah, United States, 84070
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Charlottesville, Virginia, United States, 22903
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23230
      • Richmond, Virginia, United States, 23294
      • Richmond, Virginia, United States, 23233
    • Washington
      • Lakewood, Washington, United States, 98499
      • Renton, Washington, United States, 98055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 10, 2005

Study Record Updates

Last Update Posted (Estimate)

December 27, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0858A4-316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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