Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Neural Tube Defects, Contraception, Oral Contraceptives (OC)
About this trial
This is an interventional prevention trial for Neural Tube Defects focused on measuring Healthy women requesting contraception, Folic Acid
Eligibility Criteria
Inclusion Criteria:
- Healthy women between 18 and 40 requesting oral contraception
Exclusion Criteria:
- The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study
Sites / Locations
- Orange County Clinical Trials
- Medical Center for Clinical Research
- SNBL Clinical Pharmacology Center, Inc.
- Columbia University Medical Center
- AAIPharma, Inc.
- Lyndhurst Gynecologic Associates
- Coastal Carolina Research Center
- New Orleans Center for Clinical Research
- NorthWest Kinetics
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)
Drospirenone (DRSP)/Ethinylestradiol (EE)
1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks