Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate

Criteria

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.