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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 18, 2007

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00195559 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Premenstrual Syndrome
Menstruation Disturbances

Intervention ^ICMJE

Drug: Levonorgestrel/Ethinyl Estradiol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

526

Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 49 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Brazil, Chile, Denmark, Finland, Germany, Mexico, Netherlands, Poland, Romania, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00195559

Responsible Party

Study ID Numbers ^ICMJE

0858A4-318

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Trial Manager	For Argentina, Chile, scheima@wyeth.com
Principal Investigator:	Trial Manager	For Brazil, xavierl@wyeth.com
Principal Investigator:	Trial Manager	For Denmark, Finland, Sweden, MedInfoNord@wyeth.com
Principal Investigator:	Trial Manager	For Germany, MedinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Mexico, gomezlj@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com
Principal Investigator:	Trial Managersp	For Poland, WPWZMED@wyeth.com
Principal Investigator:	Trial Manager	For Romania, WPVIMED@wyeth.com
Principal Investigator:	Trial Manager	For UK, ukmedinfo@wyeth.com

Information Provided By

Wyeth

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP