NCT00932321

Study of Safety and Efficacy of an Oral Contraceptive

Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 938 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prevention of Pregnancy

Interventions

Type	Name	Description
DRUG	Norethindrone Acetate/Ethinyl Estradiol 24 Days	One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
DRUG	Norethindrone Acetate /Ethinyl Estradiol 21 Days	One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2009-07-03
• Last updated: 2013-04-22
• Results posted: 2011-03-22

Locations

34 sites across 1 country: United States