Gestrinone and Endothelial Function in Young Women

March 7, 2025 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 Backup

Study Locations

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

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

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
Intervention / Treatment
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

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

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

Hospital Israelita Albert Einstein

Investigators

  • 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)

August 22, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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