Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
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To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.
To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.
Secondary Outcome Measures :
To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment.
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Layout table for eligibility information
Ages Eligible for Study:
up to 36 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy women of legal age of consent who are willing to use a combination OC.
Subjects must be under the age of 36 at the time of enrollment (visit 3).
Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.
Other inclusions apply.
A history or the presence of any of the following will prevent enrollment:
Thrombophlebitis, thrombosis, or thromboembolic disorders.