Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.
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Primary Outcome Measures
- To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics 
Secondary Outcome Measures
- To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women 
Women aged 18 to 35 years.
Healthy as determined by the investigator on the basis of medical history and screening evaluations.
Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.
Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)None provided.