Study of Safety and Efficacy of an Oral Contraceptive

Prevention of Pregnancy Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention of Pregnancy

• NCT number: NCT00932321
• Study type: Interventional
• Source: Warner Chilcott
• Status: Completed
• Phase: Phase 3
• Start date: January 2004
• Completion date: November 2004