Gestrinone and Endothelial Function in Young Women

Hospital Israelita Albert Einstein

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Other: Control group; Other: Hormonal implant

Study type: Observational

Funder types: Other

Identifiers

NCT06402344

75851223.3.0000.0071

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

90 participants in 2 patient groups

Gestrinone implant

Description:

Young women using hormonal implant with gestrinone.

Treatment:

Other: Hormonal implant

Control group

Description:

Young women who never used hormonal implant with gestrinone.

Treatment:

Other: Control group