Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Wyeth

Status and phase: Completed; Phase 2

Conditions: Ovulation

Treatments: Drug: Ethinyl Estradiol; Drug: Levonorgestrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254189

0858A2-208

Details and patient eligibility

About

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.

Sex: Female

Ages: Under 36 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)