Assessing the impact of gestrinone on cardiovascular health in young women
Association of Hormonal Implant With Gestrinone on Endothelial Function in Young Women
This study is testing whether a hormonal implant called gestrinone affects heart health in young women aged 25 to 45.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06402344 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between the use of a hormonal implant containing gestrinone and cardiovascular health outcomes in young women aged 25 to 45. Eligible participants will be screened based on specific criteria and will undergo assessments in a single visit at the research institute. The study will include a control group for comparison, allowing researchers to analyze the effects of gestrinone on endothelial function and overall cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25 to 45 who have either used a hormonal implant with gestrinone in the last six months or have never used any hormonal implants.
Not a fit: Patients who are pregnant, menopausal, or have a history of significant cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how hormonal treatments may influence cardiovascular health in young women.
How similar studies have performed: While there may be studies on hormonal impacts on cardiovascular health, this specific approach focusing on gestrinone in young women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
São Paulo
- Hospital Israelita Albert Einstein — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Luciana Diniz Nagem Janot de Matos, MD, PhD — Medical Referencee - Rehabilitation Center
- Study coordinator: Luciana Diniz Nagem Janot de Matos, MD, PhD
- Email: luciana.matos@einstein.br
- Phone: 551121511100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.