Cardiovascular Diseases
Conditions
Keywords
Hormonal implant, Gestrinone, Endothelial function
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.
Interventions
OTHERHormonal implant
History of at least 1 hormonal implant with gestrinone in the last 6 months, applied by the participant's private doctor.
OTHERControl group
Young women who never used any hormonal implant.
Sponsors
Hospital Israelita Albert Einstein
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | Day 1. | Brachial artery endothelial function assessed by flow-mediated dilation (FMD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial stiffness | Day 1. | Carotid-femoral pulse wave velocity (PWV). |
| Heart rate | Day 1. | Heart rate assessed together with the cardiac autonomic modulation procedure. |
| 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. |
| 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. |
| Hemoglobin | Day 1. | Hemoglobin will be analyzed by laboratory exams. |
| Hematocrit | Day 1. | Hematocrit will be analyzed by laboratory exams. |
| Progesterone | Day 1. | Progesterone will be analyzed by immunoassay technique. |
| 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. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORLuciana Diniz Nagem Janot de Matos, MD, PhD
Medical Referencee - Rehabilitation Center
Outcome results
None listed