Gestrinone and Endothelial Function in Young Women
- Conditions
- Cardiovascular Diseases
- Interventions
- Other: Hormonal implantOther: Control group
- Registration Number
- NCT06402344
- Lead Sponsor
- Hospital Israelita Albert Einstein
- Brief Summary
The purpose of this study is to assess the association of hormonal implant with gestrinone in cardiovascular health outcomes in young women.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gestrinone implant Hormonal implant Young women using hormonal implant with gestrinone. Control group Control group Young women who never used hormonal implant with gestrinone.
- Primary Outcome Measures
Name Time Method Endothelial function Day 1. Brachial artery endothelial function assessed by flow-mediated dilation (FMD).
- Secondary Outcome Measures
Name Time Method Arterial stiffness Day 1. Carotid-femoral pulse wave velocity (PWV).
Heart rate Day 1. Heart rate assessed together with the cardiac autonomic modulation procedure.
Progesterone Day 1. Progesterone will be analyzed by immunoassay technique.
Blood pressure Day 1. Systolic, diastolic and mean blood pressure will be evaluated by auscultatory method.
Cardiac autonomic modulation Day 1. Heart rate variability (HRV) analyzed in the time domain, frequency domain, and non-linear method.
Lipid profile 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.
Hemoglobin Day 1. Hemoglobin will be analyzed by laboratory exams.
Glycemia Day 1. Glycemia will be analyzed by laboratory exams.
Ultra-sensitive C-reactive protein (us-CRP) Day 1. us-CRP will be analyzed by laboratory exams.
Hematocrit Day 1. Hematocrit will be analyzed by laboratory exams.
17-alpha-hydroxyprogesterone (17-OHP) Day 1. 17-OHP will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Dehydroepiandrosterone (DHEA) Day 1. DHEA will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Androstenedione Day 1. Androstenedione will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Free testosterone Day 1. Free testosterone will be calculated considering total testosterone and SHBG.
Total testosterone Day 1. Total testosterone will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).
Estradiol Day 1. Estradiol will be analyzed by immunoassay technique.
Follicle-stimulating hormone (FSH) Day 1. FSH will be analyzed by immunoassay technique.
Luteinizing hormone (LH) Day 1. LH will be analyzed by immunoassay technique.
Sex hormone-binding globulin (SHBG) Day 1. SHBG will be analyzed by immunoassay technique.
Muscular strength Day 1. It will be assessed by handgrip.
Trial Locations
- Locations (1)
Hospital Israelita Albert Einstein
🇧🇷São Paulo, Brazil