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Active, Not Recruiting

NCT Number: NCT06402344

Gestrinone and Endothelial Function in Young Women

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hormonal implant

Other

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

Control Group

Other

Young women who never used any hormonal implant.

Primary outcomes

  1. Endothelial function

    Time frame: Day 1.

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

Secondary outcomes

  1. Arterial stiffness

    Time frame: Day 1.

    Carotid-femoral pulse wave velocity (PWV).

  2. Heart rate

    Time frame: Day 1.

    Heart rate assessed together with the cardiac autonomic modulation procedure.

  3. Blood pressure

    Time frame: Day 1.

    Systolic, diastolic and mean blood pressure will be evaluated by auscultatory method.

  4. Cardiac autonomic modulation

    Time frame: Day 1.

    Heart rate variability (HRV) analyzed in the time domain, frequency domain, and non-linear method.

  5. Lipid profile

    Time frame: 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.

  6. Glycemia

    Time frame: Day 1.

    Glycemia will be analyzed by laboratory exams.

  7. Ultra-sensitive C-reactive protein (us-CRP)

    Time frame: Day 1.

    us-CRP will be analyzed by laboratory exams.

  8. Hemoglobin

    Time frame: Day 1.

    Hemoglobin will be analyzed by laboratory exams.

  9. Hematocrit

    Time frame: Day 1.

    Hematocrit will be analyzed by laboratory exams.

  10. Progesterone

    Time frame: Day 1.

    Progesterone will be analyzed by immunoassay technique.

  11. 17-alpha-hydroxyprogesterone (17-OHP)

    Time frame: Day 1.

    17-OHP will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).

  12. Dehydroepiandrosterone (DHEA)

    Time frame: Day 1.

    DHEA will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).

  13. Androstenedione

    Time frame: Day 1.

    Androstenedione will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).

  14. Free testosterone

    Time frame: Day 1.

    Free testosterone will be calculated considering total testosterone and SHBG.

  15. Total testosterone

    Time frame: Day 1.

    Total testosterone will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS).

  16. Estradiol

    Time frame: Day 1.

    Estradiol will be analyzed by immunoassay technique.

  17. Follicle-stimulating hormone (FSH)

    Time frame: Day 1.

    FSH will be analyzed by immunoassay technique.

  18. Luteinizing hormone (LH)

    Time frame: Day 1.

    LH will be analyzed by immunoassay technique.

  19. Sex hormone-binding globulin (SHBG)

    Time frame: Day 1.

    SHBG will be analyzed by immunoassay technique.

  20. Muscular strength

    Time frame: Day 1.

    It will be assessed by handgrip.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 7, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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