Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Wyeth is now a wholly owned subsidiary of Pfizer60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovulation

Interventions

LevonorgestrelDRUG

Ethinyl EstradiolDRUG

Eligibility

Sex: FEMALEMin age: 0 YearsMax age: 36 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: A history or the presence of any of the following will prevent enrollment: * Thrombophlebitis, thrombosis, or thromboembolic disorders. * Deep vein thrombosis. * Pulmonary embolism. Other exclusions apply.

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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