Status:
COMPLETED
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Lead Sponsor:
Bayer
Conditions:
Neural Tube Defects
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether the study drug is safe and effective
Detailed Description
Acronym is used in result section: suspected/diagnosed (susp/diag)
Eligibility Criteria
Inclusion
- \- Healthy women between 18 and 40 requesting oral contraception
Exclusion
- \- The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00468481
Start Date
April 1 2007
End Date
September 1 2008
Last Update
April 23 2014
Active Locations (9)
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1
Orange County Clinical Trials
Anaheim, California, United States, 92801
2
Medical Center for Clinical Research
San Diego, California, United States, 92108
3
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States, 21201
4
Columbia University Medical Center
New York, New York, United States, 10032