Study of Safety and Efficacy of an Oral Contraceptive

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

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

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Healthy Women

• Age 18-45

• At risk for pregnancy

• History of regular cycles

Exclusion Criteria:

• Contraindications for use of hormonal contraception

• Conditions which affect the absorption or metabolism of steroid hormones

• BMI > 35