Study of Safety and Efficacy of an Oral Contraceptive

Completed · Phase 3

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT00391807

Run by

Warner Chilcott

People needed

1683

Starts

2006-11-01

Expected to finish

2008-09-01

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 — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Tempe, Arizona, United States
• Warner Chilcott Investigational Site — Tempe, Arizona, United States
• Warner Chilcott Investigational Site — Tucson, Arizona, United States
• Warner Chilcott Investigational Site — Carmichael, 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 — Clearwater, Florida, United States
• Warner Chilcott Investigational Site — Jacksonville, Florida, United States
• Warner Chilcott Investigational Site — Leesburg, Florida, United States
• Warner Chilcott Investigational Site — Longwood, Florida, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — New Port Richey, Florida, United States
• Warner Chilcott Investigational Site — Pembroke Pines, Florida, United States
• Warner Chilcott Investigational Site — Plantation, Florida, United States
• Warner Chilcott Investigational Site — St. Petersburg, Florida, United States
• Warner Chilcott Investigational Site — West Palm Beach, Florida, United States
• Warner Chilcott Investigational Site — West Palm Beach, Florida, United States
• Warner Chilcott Investigational Site — Roswell, Georgia, United States
• Warner Chilcott Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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