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

• Status: Completed
• Trial end date: 2013-09-17
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Galeno Desenvolvimento de Pesquisas Clínicas
• Collaborator: Biolab Sanus Farmaceutica
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Folic Acid; Levonorgestrel; Polyestradiol phosphate; Vitamin B Complex

Criteria

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