Study of Safety and Efficacy of an Oral Contraceptive

Completed · Phase 3 · Has a placebo group

Conditions studied: Prevention of Pregnancy

In brief

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.

Key facts

Study ID

NCT00932321

Run by

Warner Chilcott

People needed

938

Starts

2004-01-01

Expected to finish

2004-11-01

Last updated by the study team

2013-04-22

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy Women
• Age 18-45
• At risk for pregnancy
• History of regular cycles

You may not qualify if…

• Contraindications for use of hormonal contraception
• Conditions which affect the absorption or metabolism of steroid hormones
• BMI > 35

Where it is running

• Warner Chilcott Investigational Site — Birmingham, Alabama, United States
• Warner Chilcott Investigational Site — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Chico, California, United States
• Warner Chilcott Investigational Site — Los Angeles, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — Denver, Colorado, United States
• Warner Chilcott Investigational Site — Boynton Beach, Florida, United States
• Warner Chilcott Investigational Site — Jacksonville, Florida, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — Palm Harbor, Florida, United States
• Warner Chilcott Investigational Site — Venice, Florida, United States
• Warner Chilcott Investigational Site — West Palm Beach, Florida, United States
• Warner Chilcott Investigational Site — Decatur, Georgia, United States
• Warner Chilcott Investigational Site — Decatur, Georgia, United States
• Warner Chilcott Investigational Site — Powder Springs, Georgia, United States
• Warner Chilcott Investigational Site — Roswell, Georgia, United States
• Warner Chilcott Investigational Site — Savannah, Georgia, United States
• Warner Chilcott Investigational Site — Louisville, Kentucky, United States
• Warner Chilcott Investigational Site — Kansas City, Missouri, United States
• Warner Chilcott Investigational Site — St Louis, Missouri, United States
• Warner Chilcott Investigational Site — New Bern, North Carolina, United States
• Warner Chilcott Investigational Site — Winston-Salem, North Carolina, United States
• Warner Chilcott Investigational Site — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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