The objective of this study is to compare the red blood cell (RBC) and plasma concentrations of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination. Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before and in the first few weeks of pregnancy has been shown to reduce certain types of birth defects. This is important for women who may become pregnant following discontinuation of oral contraception. Information about any side effects that may occur will also be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
34
One tablet DRSP 3 mg/EE 0.02 mg/ Levomefolate calcium 0.451 mg daily for 24 days, followed by one hormone-free tablet L-5-MTHF 0.451 mg daily for 4 days over 24 weeks
Unnamed facility
Mexico City, Mexico City, Mexico
Change in RBC folate concentration from baseline to Week 24
Time frame: Baseline and Week 24
Change in plasma folate concentration from baseline to Week 24
Time frame: Baseline and Week 24
RBC folate concentration
Time frame: Different time points up to 32 weeks
Plasma folate concentration
Time frame: Different time points up to 32 weeks
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