Gestrinone and Endothelial Function in Young Women

NCT06402344 | Recruiting

• 1 other identifier: 75851223.3.0000.0071
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases

Keywords

Hormonal implant; Gestrinone; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Endothelial function

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

  Day 1.

Secondary Outcomes (20)

• Arterial stiffness

  Day 1.

• Heart rate

  Day 1.

• Blood pressure

  Day 1.

• Cardiac autonomic modulation

  Day 1.

• Lipid profile

  Day 1.

Study Arms (2)

Gestrinone implant

Young women using hormonal implant with gestrinone.

Other: Hormonal implant

Control group

Young women who never used hormonal implant with gestrinone.

Other: Control group

Interventions

Hormonal implant OTHER

History of at least 1 hormonal implant with gestrinone in the last 6 months, applied by the participant's private doctor.

Gestrinone implant

Control group OTHER

Young women who never used any hormonal implant.

Control group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young women.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Luciana Diniz Nagem Janot de Matos, MD, PhD

  Medical Referencee - Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Diniz Nagem Janot de Matos, MD, PhD

CONTACT

551121511100; luciana.matos@einstein.br

Igor Rezende Trevisan, BSc

CONTACT

5511943911224; igor19trevisan@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 7, 2024
• Study Start: August 22, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)