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

Galeno Desenvolvimento de Pesquisas Clínicas

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: ethinyl estradiol + levonorgestrel + folic acid

Drug: Folic Acid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03359057

GDN 028/12

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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