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

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ClinicalTrials.gov Identifier: NCT03359057
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
Biolab Sanus Farmaceutica
Information provided by (Responsible Party):
Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: ethinyl estradiol + levonorgestrel + folic acid Drug: Folic Acid Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel (Ethinyl Estradiol + Levonorgestrel + Folic Acid - Coated Tablet - 0.02 mg + 0.10 mg + 0.4 mg; Biolab Sanus Farmaceutica Ltda) in Female Volunteers.
Actual Study Start Date : February 26, 2013
Actual Primary Completion Date : July 4, 2013
Actual Study Completion Date : September 17, 2013


Arm Intervention/treatment
Experimental: Estradiol + levonorgestrel + folic acid
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
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).

Placebo Comparator: Folic acid
Coated tablet of placebo coated tablet containing folic acid 0.4 mg only on the last 7 days of the cycle.
Drug: Folic Acid
One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).




Primary Outcome Measures :
  1. Measurement of folate levels in erythrocytes. [ Time Frame: 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 Outcome Measures :
  1. Number of adverse events [ Time Frame: 0-84 days ]
    Number of adverse events, including clinically relevant alterations of vital signs and laboratory tests results



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359057


Locations
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Brazil
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, SP, Brazil
Sponsors and Collaborators
Galeno Desenvolvimento de Pesquisas Clínicas
Biolab Sanus Farmaceutica
Investigators
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Principal Investigator: Gilberto De Nucci, Doctor Galeno Desenvolvimento de Pesquisas Clinicas Ltda

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Responsible Party: Gilberto De Nucci, Doctor, Galeno Desenvolvimento de Pesquisas Clínicas
ClinicalTrials.gov Identifier: NCT03359057     History of Changes
Other Study ID Numbers: GDN 028/12
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas:
Folic acid
Supplementation
Ethinyl estradiol
Levonorgestrel
Oral contraceptive
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Ethinyl estradiol, levonorgestrel drug combination
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Folic Acid
Vitamin B Complex
Levonorgestrel
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined