Contraception
Conditions
Keywords
Folic acid, Supplementation, Ethinyl estradiol, Levonorgestrel, Oral contraceptive
Brief 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.
Detailed description
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.
Interventions
DRUGethinyl 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).
DRUGFolic Acid
One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
Sponsors
Biolab Sanus Farmaceutica
Galeno Desenvolvimento de Pesquisas Clínicas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Female volunteers aged between 18 and 35 years old (fertile age), without hormonal contraceptive use at least 3 months (oral) or 1 year (injectable), regular cycle and no pregnant or breastfeeding; * Body mass index (BMI) ≥ 19.0 kg/m² and ≤ 28.75 kg/m² * No evidence of significant diseases, that, at the investigator's discretion, may affect the participation in the clinical trial, in accordance with the protocol requirements * Ability to understand the nature and the objective of the clinical trial, including the risks and possible side effects; intention to cooperate with the investigator and act in accordance with the protocol requirements, as confirmed by the informed consent form signature.
Exclusion criteria
* Subjects with known hypersensitivity to the compounds of the investigational products, severe allergies or multiple drug allergies * Existing diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the drug * Screening laboratory tests presenting deviations deemed as clinically significant, which, due to possible risks, prevents the participation in clinical trial. * Use of maintenance therapy with any drug * Drug or alcohol dependence * Volunteers who ingests more than 5 cups of coffee or tea per day and/or smoke * Volunteers with unusual eating habits, e.g, vegetarian * Treatment, within 3 months prior to the initiation of the clinical trial treatment, with any drug known to have a well-established toxic potential to major organs. * Use of regular medication within 2 weeks before the start of treatment and the date of evaluation, or made use of any medication within one week, except for oral contraceptives or cases where, based on the half-life of the drug and/or active metabolites, complete elimination can be assumed * Treatment within 6 months prior to the study with any known drug of have a well-defined toxic potential in large organs * Hospitalization for any reason up to 8 weeks before the start of the treatment of this study * Participation in a clinical trial during the last 6 months * Blood donation or other blood loss of more than 450 mL within the last 3 months * Pregnant, delivery or abortion in the 12 weeks prior to the planned hospitalization * The volunteer who has any condition that prevents him from participating in the study by judgment of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of folate levels in erythrocytes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 0-84 days | Number of adverse events, including clinically relevant alterations of vital signs and laboratory tests results |
Countries
Brazil
Outcome results
None listed