Gestrinone and Endothelial Function in Young Women

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: Active, not recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Hormonal implant; Other: Control group

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	Brachial artery endothelial function assessed by flow-mediated dilation (FMD).	Day 1.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial stiffness	Carotid-femoral pulse wave velocity (PWV).	Day 1.
Heart rate	Heart rate assessed together with the cardiac autonomic modulation procedure.	Day 1.
Glycemia	Glycemia will be analyzed by laboratory exams.	Day 1.
Ultra-sensitive C-reactive protein (us-CRP)	us-CRP will be analyzed by laboratory exams.	Day 1.
Hemoglobin	Hemoglobin will be analyzed by laboratory exams.	Day 1.
Hematocrit	Hematocrit will be analyzed by laboratory exams.	Day 1.
Progesterone	Progesterone will be analyzed by immunoassay technique.	Day 1.
17-alpha-hydroxyprogesterone (17-OHP)	17-OHP will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Dehydroepiandrosterone (DHEA)	DHEA will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Androstenedione	Androstenedione will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Free testosterone	Free testosterone will be calculated considering total testosterone and SHBG.	Day 1.
Total testosterone	Total testosterone will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Estradiol	Estradiol will be analyzed by immunoassay technique.	Day 1.
Follicle-stimulating hormone (FSH)	FSH will be analyzed by immunoassay technique.	Day 1.
Luteinizing hormone (LH)	LH will be analyzed by immunoassay technique.	Day 1.
Sex hormone-binding globulin (SHBG)	SHBG will be analyzed by immunoassay technique.	Day 1.
Cardiac autonomic modulation	Heart rate variability (HRV) analyzed in the time domain, frequency domain, and non-linear method.	Day 1.
Muscular strength	It will be assessed by handgrip.	Day 1.
Blood pressure	Systolic, diastolic and mean blood pressure will be evaluated by auscultatory method.	Day 1.
Lipid profile	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

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Luciana Diniz Nagem Janot de Matos, MD, PhD, Medical Referencee - Rehabilitation Center

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Estimated): August 5, 2026

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): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Endothelial function; Hormonal implant; Gestrinone
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• 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