Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oral Contraceptive
Intervention: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: 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 design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Additional Information
Ending date: October 2004
Last updated: May 17, 2006
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