Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Wyeth is now a wholly owned subsidiary of Pfizer2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

2,000

Conditions

Contraception

Interventions

Levonorgestrel 90 mg/Ethinyl Estradiol 20 mgDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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.

Data from ClinicalTrials.gov

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