Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Wyeth is now a wholly owned subsidiary of Pfizer600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

ECT

Masking

NONE

Enrollment

600

Conditions

Oral Contraceptive

Interventions

Levonorgestrel 90 mg and Ethinyl Estradiol 20 mgDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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