This trial evaluated folic acid supplementation after oral administration of the ethinyl estradiol + levonorgestrel + folic acid (0.02 mg + 0.10 mg + 0.4 mg) coated tablet (Level-Fol® Biolab Sanus Farmacêutica, São Paulo, Brazil) in healthy female volunteers, based on statistical comparisons of folate levels in erythrocytes. Its safety and tolerability was also evaluated.
This Phase III trial was performed as a monocentric, open label, randomized design, with 1 treatment regimen, in 3 cycles (12 weeks), with administration in multiple doses, in which the healthy volunteers received one coated tablet of the test product - ethinyl estradiol + levonorgestrel + folic acid, 0.02 mg + 0.10 mg + 0.4 mg (Level-Fol® Biolab Sanus Farmaceutica, Brazil) for 21 days and a placebo coated tablet containing folic acid 0.4 mg only (Biolab Sanus Farmaceutica, Brazil) on the last 7 days of the cycle. The subjects were required to present to the Clinical Unit for every drug administration, which was assisted by a member of the research team. Blood samples of 15 mL were collected via direct venepuncture into tubes containing 50 µL of ethylenediaminetetraacetic acid (EDTA) at pre-dose, 1st, 21st, 28th, 29th, 49th, 56th, 57th, 77th and 84th day of treatment. Te safety assessment was based on recording adverse events throughout the study duration as well as through the monitoring of vital signs and evaluation of laboratory tests and ECG.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
One coated tablet of ethinyl estradiol + levonorgestrel + folic acid, 0.02 mg + 0.10 mg + 0.4 mg for 21 days in 3 cycles (12 weeks).
One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo, Brazil
Measurement of folate levels in erythrocytes.
Blood sampling for the determination of erythrocyte levels of folate in the subjects after the treatment with the test drug or placebo.
Time frame: 0-84 days
Number of adverse events
Number of adverse events, including clinically relevant alterations of vital signs and laboratory tests results
Time frame: 0-84 days
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