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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

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Author(s):
Jacob, Juliana de Moraes [1, 2] ; Antunes, Natalicia de Jesus [1] ; Moreno, Ronilson [1] ; De Nucci, Gilberto [1]
Total Authors: 4
Affiliation:
[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
Total Affiliations: 2
Document type: Journal article
Source: INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS; v. 57, n. 6, p. 290-297, JUN 2019.
Web of Science Citations: 0
Abstract

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)

FAPESP's process: 16/22506-1 - Metabolism of dapaconazole
Grantee:Natalícia de Jesus Antunes
Support Opportunities: Scholarships in Brazil - Post-Doctoral