Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

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

Summary

To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Contraceptive Agents; Contraceptives, Oral; 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 who are willing to rely upon a combination birth control pill as their only method of contraception.

• Women must be sexually active and at risk for becoming pregnant.

• Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion Criteria:

• High blood pressure

• Age greater then 34 and smoking more than 15 cigarettes per day.

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