Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
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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.
Condition or disease
Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg
A Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous 28-Day Regimen for Oral Contraception Versus a Cyclic 21-Day Regimen Oral Contraceptive
Study Completion Date :
Resource links provided by the National Library of Medicine
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 Outcome Measures :
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
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Ages Eligible for Study:
18 Years to 49 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.