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

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

May 25, 2007

Start Date ^ICMJE

August 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To evaluate the efficacy of a continuous-use oral contraceptive regimen containing a combination of LNG/EE in preventing moderate to severe menstrual cycle-related symptoms compared with placebo.

Change History

Complete list of historical versions of study NCT00161681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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

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

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

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

United States

Administrative Information

NCT ID ^ICMJE

NCT00161681

Responsible Party

Study ID Numbers ^ICMJE

0858A2-322

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

May 2007

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