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

NCT03359057 | Completed Phase 3 DMC

• 1 other identifier: GDN 028/12
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Folic acid; Supplementation; Ethinyl estradiol; Levonorgestrel; Oral contraceptive

Outcome Measures

Primary Outcomes (1)

• Measurement of folate levels in erythrocytes.

  Blood sampling for the determination of erythrocyte levels of folate in the subjects after the treatment with the test drug or placebo.

  0-84 days

Secondary Outcomes (1)

• Number of adverse events

  0-84 days

Study Arms (2)

Estradiol + levonorgestrel + folic acid

EXPERIMENTAL

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

Folic acid

PLACEBO COMPARATOR

Coated tablet of placebo coated tablet containing folic acid 0.4 mg only on the last 7 days of the cycle.

Drug: Folic Acid

Interventions

ethinyl estradiol + levonorgestrel + folic acid DRUG

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).

Estradiol + levonorgestrel + folic acid

Folic Acid DRUG

One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).

Folic acid

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galeno Desenvolvimento de Pesquisas Clínicas: lead
• Biolab Sanus Farmaceutica: collaborator

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Campinas, São Paulo, Brazil

Location

MeSH Terms

Interventions

Ethinyl Estradiol; Levonorgestrel; Folic Acid

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norgestrel; Norpregnenes; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gilberto De Nucci, Doctor

  Galeno Desenvolvimento de Pesquisas Clinicas Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: February 26, 2013
• Primary Completion: July 4, 2013
• Study Completion: September 17, 2013
• Last Updated: December 4, 2017

Record last verified: 2017-11

Locations

BR (1)