Status:
COMPLETED
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel
Lead Sponsor:
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborating Sponsors:
Biolab Sanus Farmaceutica
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
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 Far...
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 volunt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03359057
Start Date
February 26 2013
End Date
September 17 2013
Last Update
December 4 2017
Active Locations (1)
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1
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo, Brazil