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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites2,000 target enrollmentFebruary 2003

ConditionsContraception

DrugsLevonorgestrel 90 mg/Ethinyl Estradiol 20 mg

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Contraception
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 2000
Primary Endpoint: To evaluate safety and contraceptive efficacy
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

October 2005

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

To evaluate safety and contraceptive efficacy

Secondary Outcomes

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.