Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

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 aged 18 to 49 years

• Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1

• Must be sexually active and at risk for becoming pregnant.

Exclusion Criteria:

• Planned use of any other form of birth control other than the test article.

• Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.

• High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).