Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Wyeth

Status and phase

Completed

Phase 3

Conditions

Oral Contraceptive

Treatments

Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00248963

0858A2-315

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.