Gestrinone and Endothelial Function in Young Women

Cardiovascular Diseases Clinical Trial

Official title:

Association of Hormonal Implant With Gestrinone on Endothelial Function in Young Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402344
• Other study ID #: 75851223.3.0000.0071
• Status: Recruiting
• Start date: May 27, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: Hospital Israelita Albert Einstein
• Contact: Luciana Diniz Nagem Janot de Matos, MD, PhD
• Phone: 551121511100
• Email: luciana.matos[@]einstein.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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 (> 14 drinks per week);

• Previous cardiovascular event (e.g. myocardial infarction and stroke);

• Cardiovascular disease (e.g. ischemic heart disease and heart failure);

• Pulmonary disease;

• Metabolic disease;

• Uncontrolled psychiatric disease;

• Endometriosis diagnosis;

• Ventricular arrhythmia;

• Using antibiotics or corticoids;

• Regular contraceptive use (estrogen and progesterone);

• Use of illicit drugs;

• Use of medications for cardiovascular disease (e.g. antihypertensive drugs).

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Brachial artery endothelial function assessed by flow-mediated dilation (FMD).	Day 1.
Secondary	Arterial stiffness	Carotid-femoral pulse wave velocity (PWV).	Day 1.
Secondary	Heart rate	Heart rate assessed together with the cardiac autonomic modulation procedure.	Day 1.
Secondary	Blood pressure	Systolic and diastolic blood pressure will be evaluated by auscultatory method.	Day 1.
Secondary	Lipid profile	Total cholesterol, very-low-density lipoprotein (VLDL-c), low-density lipoprotein (LDL-c), high-density lipoprotein (HDL-c), and triglycerides will be analyzed by laboratory exams.	Day 1.
Secondary	Glycemia	Glycemia will be analyzed by laboratory exams.	Day 1.
Secondary	Ultra-sensitive C-reactive protein (us-CRP)	us-CRP will be analyzed by laboratory exams.	Day 1.
Secondary	Hemoglobin	Hemoglobin will be analyzed by laboratory exams.	Day 1.
Secondary	Hematocrit	Hematocrit will be analyzed by laboratory exams.	Day 1.
Secondary	Progesterone	Progesterone will be analyzed by immunoassay technique.	Day 1.
Secondary	17-alpha-hydroxyprogesterone (17-OHP)	17-OHP will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Secondary	Dehydroepiandrosterone (DHEA)	DHEA will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Secondary	Androstenedione	Androstenedione will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Secondary	Free testosterone	Free testosterone will be calculated considering total testosterone and SHBG.	Day 1.
Secondary	Total testosterone	Total testosterone will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).	Day 1.
Secondary	Estradiol	Estradiol will be analyzed by immunoassay technique.	Day 1.
Secondary	Follicle-stimulating hormone (FSH)	FSH will be analyzed by immunoassay technique.	Day 1.
Secondary	Luteinizing hormone (LH)	LH will be analyzed by immunoassay technique.	Day 1.
Secondary	Sex hormone-binding globulin (SHBG)	SHBG will be analyzed by immunoassay technique.	Day 1.
Secondary	Cardiac autonomic modulation	Heart rate variability (HRV) analyzed in the time domain, frequency domain, and non-linear method.	Day 1.
Secondary	Muscular strength	It will be assessed by handgrip.	Day 1.