Efficacy and Safety Study for an Oral Contraceptive Containing Folate

Completed · Phase 3

Conditions studied: Neural Tube Defects, Contraception, Oral Contraceptives (OC)

In brief

The purpose of this study is to determine whether the study drug is safe and effective

Key facts

Study ID

NCT00468481

Run by

Bayer

People needed

385

Starts

2007-04-01

Expected to finish

2008-09-01

Last updated by the study team

2014-04-23

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy women between 18 and 40 requesting oral contraception

You may not qualify if…

• The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study

Where it is running

• Orange County Clinical Trials — Anaheim, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• SNBL Clinical Pharmacology Center, Inc. — Baltimore, Maryland, United States
• Columbia University Medical Center — New York, New York, United States
• AAIPharma, Inc. — Morrisville, North Carolina, United States
• Lyndhurst Gynecologic Associates — Winston-Salem, North Carolina, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
• NorthWest Kinetics — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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