Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 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/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

526

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

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina
      • Cordoba, Argentina
      • Rosario-Santa Fe, Argentina
  • Brazil
      • Curitiba, Brazil
      • Goiania, Brazil
      • Porto Alegre, Brazil
      • Salvador, Brazil
      • Sao Paulo, Brazil
      • Sorocaba, Brazil
  • Chile
      • Santiago, Chile
      • Temuco, Chile
  • Denmark
      • Arhus, Denmark
      • Frederiksberg, Denmark
      • Kobenhavn NV, Denmark
      • Rungsted Kyst, Denmark
  • Finland
      • Helsinki, Finland
      • Kuopio, Finland
      • Oulu, Finland
      • Turku, Finland
  • Germany
      • Berlin, Germany
      • Bonn, Germany
      • Hamburg, Germany
      • Hannover, Germany
  • Mexico
      • Mexico City, Mexico
    • D.f.
      • Lomas de Virreyes, D.f., Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
      • Zapopan, Jalisco, Mexico
    • N.l.
      • Monterrey, N.l., Mexico
    • SLP
      • San Luis Potosi, SLP, Mexico
  • Netherlands
      • Amsterdam, Netherlands
      • Apeldoorn, Netherlands
      • Den Helder, Netherlands
      • Enschede, Netherlands
      • Nieuwegein, Netherlands
  • Poland
      • Bialystok, Poland
      • Gdansk, Poland
      • Myslowice, Poland
      • Poznan, Poland
      • Warszawa, Poland
  • Romania
      • Bucuresti, Romania
        • S
      • Cluj-Napoca, Romania
      • Iasi, Romania
  • Sweden
      • Goteborg, Sweden
      • Stockholm, Sweden
      • Umea, Sweden
      • Uppsala, Sweden
  • United Kingdom
      • Conwell, United Kingdom
      • Fowey, United Kingdom
      • London, United Kingdom
      • Plymouth, United Kingdom
      • St. Austell, United Kingdom

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 exclusion applies.

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

Investigators

  • Principal Investigator: Trial Manager, For Brazil, xavierl@wyeth.com
  • Principal Investigator: Trial Manager, For Mexico, gomezlj@wyeth.com
  • Principal Investigator: Trial Manager, For Romania, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Argentina, Chile, scheima@wyeth.com
  • Principal Investigator: Trial Manager, For Denmark, Finland, Sweden, MedInfoNord@wyeth.com
  • Principal Investigator: Trial Managersp, For Poland, WPWZMED@wyeth.com

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

September 1, 2005

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 19, 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

  • 0858A4-318

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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