Evaluation of folic acid supplementation by concomitant administration of ethinyl estradiol plus levonorgestrel in healthy female subjects

Autor(es)

Jacob, Juliana de Moraes ^{[1, 2]} ; Antunes, Natalicia de Jesus ^[1] ; Moreno, Ronilson ^[1] ; De Nucci, Gilberto ^[1]

Afiliação do(s) autor(es)

^[1] State Univ Campinas UNICAMP, Fac Med Sci, Dept Pharmacol, Alexander Flemming St 105, BR-13083881 Campinas, SP - Brazil

^[2] Fed Univ Triangulo Mineiro UNITRI, Uberaba, MG - Brazil

• Tipo de documento: Artigo Científico
• Fonte: INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS; v. 57, n. 6, p. 290-297, JUN 2019.
• Citações Web of Science: 0

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. (AU)

• Processo FAPESP: 16/22506-1 - Metabolismo do dapaconazol
• Beneficiário: Natalícia de Jesus Antunes
• Modalidade de apoio: Bolsas no Brasil - Pós-Doutorado