Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Phase 2

Completed

• Conditions: Ovulation

• Registration Number: NCT00254189
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2004-10
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-17
• Last Update Posted: 2006-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.