Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
Phase 3
Completed
- Conditions
- Oral Contraceptive
- Registration Number
- NCT00248963
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the contraceptive efficacy of levonorgestrel and ethinyl estradiol combinations in continuous versus cyclic regimens?
How does the 28-day continuous regimen of LNG 90 mg/EE 20 mg compare to cyclic 21-day regimens in contraceptive effectiveness and adverse event profiles?
Are there specific biomarkers or patient characteristics that predict better outcomes with continuous oral contraceptive regimens containing levonorgestrel and ethinyl estradiol?
What are the long-term safety implications of continuous versus cyclic progestin-estrogen contraceptive regimens as studied in NCT00248963?
How does the efficacy and safety of LNG/EE continuous regimen compare to other combined oral contraceptive formulations in clinical use?