NCT00391807

Study of Safety and Efficacy of an Oral Contraceptive

Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,683 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a non-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; and to assess the safety and tolerability of the product.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Norethindrone acetate/ethinyl estradiol	one tablet per day

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2006-10-24
• Last updated: 2013-04-22
• Results posted: 2010-12-22

Locations

66 sites across 1 country: United States