Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception - Tabular View

Tracking Information

First Received Date ^ICMJE

October 26, 2005

Last Updated Date

May 17, 2006

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To evaluate safety and contraceptive efficacy

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00245921 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Official Title ^ICMJE

A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous Daily Regimen for Oral Contraception

Brief Summary

To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Contraception

Intervention ^ICMJE

Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg

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

2000

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 the 3-month period preceding visit 1
Must be sexually active and at risk for becoming pregnant.

Exclusion Criteria:

Planned use of any other form of birth control other than the test article.
Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).

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

Administrative Information

NCT ID ^ICMJE

NCT00245921

Responsible Party

Study ID Numbers ^ICMJE

0858A2-313, 314, 320

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

May 2006

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