Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel
|ClinicalTrials.gov Identifier: NCT03359057|
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : December 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: ethinyl estradiol + levonorgestrel + folic acid Drug: Folic Acid||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel (Ethinyl Estradiol + Levonorgestrel + Folic Acid - Coated Tablet - 0.02 mg + 0.10 mg + 0.4 mg; Biolab Sanus Farmaceutica Ltda) in Female Volunteers.|
|Actual Study Start Date :||February 26, 2013|
|Actual Primary Completion Date :||July 4, 2013|
|Actual Study Completion Date :||September 17, 2013|
Experimental: Estradiol + levonorgestrel + folic acid
Coated tablet of the test product - ethinyl estradiol + levonorgestrel + folic acid, 0.02 mg + 0.10 mg + 0.4 mg for 21 days.
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).
Placebo Comparator: Folic acid
Coated tablet of placebo coated tablet containing folic acid 0.4 mg only on the last 7 days of the cycle.
Drug: Folic Acid
One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
- Measurement of folate levels in erythrocytes. [ Time Frame: 0-84 days ]Blood sampling for the determination of erythrocyte levels of folate in the subjects after the treatment with the test drug or placebo.
- Number of adverse events [ Time Frame: 0-84 days ]Number of adverse events, including clinically relevant alterations of vital signs and laboratory tests results
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359057
|Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME|
|Campinas, SP, Brazil|
|Principal Investigator:||Gilberto De Nucci, Doctor||Galeno Desenvolvimento de Pesquisas Clinicas Ltda|