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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

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 2, 2017
Last Update Posted Date December 4, 2017
Actual Study Start Date  ICMJE February 26, 2013
Actual Primary Completion Date July 4, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03359057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
Number of adverse events [ Time Frame: 0-84 days ]
Number of adverse events, including clinically relevant alterations of vital signs and laboratory tests results
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE
  • 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).
  • Drug: Folic Acid
    One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ethinyl estradiol + levonorgestrel + folic acid
  • 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.
    Intervention: Drug: Folic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2017)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 17, 2013
Actual Primary Completion Date July 4, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03359057
Other Study ID Numbers  ICMJE GDN 028/12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas
Study Sponsor  ICMJE Galeno Desenvolvimento de Pesquisas Clínicas
Collaborators  ICMJE Biolab Sanus Farmaceutica
Investigators  ICMJE
Principal Investigator: Gilberto De Nucci, Doctor Galeno Desenvolvimento de Pesquisas Clinicas Ltda
PRS Account Galeno Desenvolvimento de Pesquisas Clínicas
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP