Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Phase 3

Completed

• Conditions: Contraception

• Registration Number: NCT00245921
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Status Verified: 2006-05
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate safety and contraceptive efficacy

Secondary Outcome Measures

Name	Time	Method
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.