- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03359057
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
SP
-
Campinas, SP, Brazil
- Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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.
|
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.
|
One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0-84 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of adverse events
Time Frame: 0-84 days
|
Number of adverse events, including clinically relevant alterations of vital signs and laboratory tests results
|
0-84 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Micronutrients
- Vitamins
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Hematinics
- Contraceptives, Oral, Hormonal
- Levonorgestrel
- Estradiol
- Ethinyl Estradiol
- Folic Acid
- Vitamin B Complex
Other Study ID Numbers
- GDN 028/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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