Contraception Clinical Trial
Official title:
Prospective, Open-label, Single-center Clinical Study to Investigate the Red Blood Cell and Plasma Folate Concentrations During a 24-week Treatment Period With the Combination of Drospirenone 3 mg Plus Ethinyl Estradiol 0.02 mg Plus Levomefolate Calcium 0.451 mg in Mexican Women Seeking Contraception
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.
n/a
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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