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Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel

NCT03359057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-12-04

No results posted yet for this study

Summary

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.

Conditions

  • Contraception

Interventions

DRUG

ethinyl estradiol + levonorgestrel + folic acid

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).

DRUG

Folic Acid

One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    collaborator INDUSTRY

  • Galeno Desenvolvimento de Pesquisas Clínicas

    lead OTHER_GOV

Principal Investigators

  • Gilberto De Nucci, Doctor · Galeno Desenvolvimento de Pesquisas Clinicas Ltda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-26
Primary Completion
2013-07-04
Completion
2013-09-17

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359057 on ClinicalTrials.gov