Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
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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.
An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women
Study Start Date :
Study Completion Date :
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Ages Eligible for Study:
18 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.