Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE.

Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Women 18 - 35 years of age

• Non-smokers

Exclusion Criteria:

• History of thromboembolic disease

• Prior adverse experiences with oral contraceptives