Gestrinone and Endothelial Function in Young Women

July 1, 2026 updated by: Hospital Israelita Albert Einstein

Association of Hormonal Implant With Gestrinone on Endothelial Function in Young Women

The purpose of this study is to assess the association of hormonal implant with gestrinone in cardiovascular health outcomes in young women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study, volunteers will be screened in accordance with eligibility criteria. Eligible volunteers will be invited to appear to the research institute and participate in the study. All volunteers giving the written informed consent will perform all assessments in the same day at their visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05652-900
        • Hospital Israelita Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Young women.

Description

Inclusion Criteria:

  • Women;
  • Between 25 and 45 years age;
  • History of ≥ 1 hormonal implant with gestrinone in the last 6 months or never had used any hormonal implants.

Exclusion Criteria:

  • Pregnancy;
  • Menopause;
  • Smoking;
  • Moderate-high consumption of alcoholic beverages (above 14 drinks per week);
  • Previous cardiovascular event (e.g. myocardial infarction and stroke);
  • Uncontrolled psychiatric disease;
  • Ventricular arrhythmia;
  • Using antibiotics or corticoids;
  • Regular contraceptive use (estrogen and progesterone);
  • Use of illicit drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Gestrinone implant
Young women using hormonal implant with gestrinone.
Other: Hormonal implant
History of at least 1 hormonal implant with gestrinone in the last 6 months, applied by the participant's private doctor.
Control group
Young women who never used hormonal implant with gestrinone.
Other: Control group
Young women who never used any hormonal implant.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: Day 1.
Brachial artery endothelial function assessed by flow-mediated dilation (FMD).
Day 1.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arterial stiffness
Time Frame: Day 1.
Carotid-femoral pulse wave velocity (PWV).
Day 1.
Heart rate
Time Frame: Day 1.
Heart rate assessed together with the cardiac autonomic modulation procedure.
Day 1.
Glycemia
Time Frame: Day 1.
Glycemia will be analyzed by laboratory exams.
Day 1.
Ultra-sensitive C-reactive protein (us-CRP)
Time Frame: Day 1.
us-CRP will be analyzed by laboratory exams.
Day 1.
Hemoglobin
Time Frame: Day 1.
Hemoglobin will be analyzed by laboratory exams.
Day 1.
Hematocrit
Time Frame: Day 1.
Hematocrit will be analyzed by laboratory exams.
Day 1.
Progesterone
Time Frame: Day 1.
Progesterone will be analyzed by immunoassay technique.
Day 1.
17-alpha-hydroxyprogesterone (17-OHP)
Time Frame: Day 1.
17-OHP will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Day 1.
Dehydroepiandrosterone (DHEA)
Time Frame: Day 1.
DHEA will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Day 1.
Androstenedione
Time Frame: Day 1.
Androstenedione will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Day 1.
Free testosterone
Time Frame: Day 1.
Free testosterone will be calculated considering total testosterone and SHBG.
Day 1.
Total testosterone
Time Frame: Day 1.
Total testosterone will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Day 1.
Estradiol
Time Frame: Day 1.
Estradiol will be analyzed by immunoassay technique.
Day 1.
Follicle-stimulating hormone (FSH)
Time Frame: Day 1.
FSH will be analyzed by immunoassay technique.
Day 1.
Luteinizing hormone (LH)
Time Frame: Day 1.
LH will be analyzed by immunoassay technique.
Day 1.
Sex hormone-binding globulin (SHBG)
Time Frame: Day 1.
SHBG will be analyzed by immunoassay technique.
Day 1.
Cardiac autonomic modulation
Time Frame: Day 1.
Heart rate variability (HRV) analyzed in the time domain, frequency domain, and non-linear method.
Day 1.
Muscular strength
Time Frame: Day 1.
It will be assessed by handgrip.
Day 1.
Blood pressure
Time Frame: Day 1.
Systolic, diastolic and mean blood pressure will be evaluated by auscultatory method.
Day 1.
Lipid profile
Time Frame: Day 1.
Total cholesterol, non-HDL cholesterol, low-density lipoprotein (LDL-c), high-density lipoprotein (HDL-c), and triglycerides will be analyzed by laboratory exams.
Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Israelita Albert Einstein

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luciana Diniz Nagem Janot de Matos, MD, PhD, Medical Referencee - Rehabilitation Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 75851223.3.0000.0071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There will be no individual participant data (IPD) shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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