RESUMO
OBJECTIVES: Folic acid supplementation prevents 50 - 75% of cases of neural tube defects. This study evaluated the folic acid supplementation after oral administration of the ethinyl estradiol 0.02 mg + levonorgestrel 0.10 mg + folic acid 0.4 mg coated tablet as well as its safety and tolerability in healthy female subjects. MATERIALS AND METHODS: 36 healthy female subjects received 1 coated tablet of the test product - ethinyl estradiol 0.02 mg + levonorgestrel 0.10 mg + folic acid 0.4 mg for 21 days and a placebo coated tablet containing folic acid 0.4 mg only on the last 7 days of the cycle, in 3 cycles. Blood samples were collected to quantify folate by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The safety was assessed by recording adverse events, monitoring of vital signs, and the evaluation of laboratory tests and ECG. RESULTS: The mean whole blood level of folic acid at baseline (1st day of 1st cycle) was 42.7 ± 22.2 ng/mL, while on the 28th day of the 3rd cycle it was 47.6 ± 20.1 ng/mL, with a variation of 11.32%. The subjects tolerated the clinical protocol well and reported no clinically significant adverse effects. CONCLUSION: Oral contraceptives may be a good vehicle for folate supplementation in women of reproductive age.