Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Levonorgestrel 90 mg/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 safety and contraceptive efficacy of an oral contraceptive containing a
combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.
Clinical Details
Official title: A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous Daily Regimen for Oral Contraception
Study design: Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate safety and contraceptive efficacy
Secondary outcome: To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy women aged 18 to 49 years
- Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
- Must be sexually active and at risk for becoming pregnant.
Exclusion Criteria:
- Planned use of any other form of birth control other than the test article.
- Depression requiring hospitalization or associated with suicidal ideation within the
last 3 years.
- High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).
Locations and Contacts
Additional Information
Starting date: March 2004
Last updated: May 17, 2006
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