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

Tracking Information

First Received Date ^ICMJE

November 2, 2005

Last Updated Date

May 17, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To evaluate the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00248963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Official Title ^ICMJE

A Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous 28-Day Regimen for Oral Contraception Versus a Cyclic 21-Day Regimen Oral Contraceptive

Brief Summary

To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Oral Contraceptive

Intervention ^ICMJE

Drug: Levonorgestrel 90 mg and 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

600

Completion Date

October 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception.
Women must be sexually active and at risk for becoming pregnant.
Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion Criteria:

High blood pressure
Age greater then 34 and smoking more than 15 cigarettes per day.
Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.

Gender

Female

Ages

18 Years to 49 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00248963

Responsible Party

Study ID Numbers ^ICMJE

0858A2-315

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