NCT06402344进行中（未招募）不适用
Association of Hormonal Implant With Gestrinone on Endothelial Function in Young Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
The purpose of this study is to assess the association of hormonal implant with gestrinone in cardiovascular health outcomes in young women.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Pregnancy;
- •Menopause;
- •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.
研究组 & 干预措施
Gestrinone implant
Young women using hormonal implant with gestrinone.
干预措施: Hormonal implant (Other)
Control group
Young women who never used hormonal implant with gestrinone.
干预措施: Control group (Other)
结局指标
主要结局
Endothelial function
时间窗: Day 1.
Brachial artery endothelial function assessed by flow-mediated dilation (FMD).
次要结局
- Arterial stiffness(Day 1.)
- Heart rate(Day 1.)
- Progesterone(Day 1.)
- Blood pressure(Day 1.)
- Cardiac autonomic modulation(Day 1.)
- Lipid profile(Day 1.)
- Hemoglobin(Day 1.)
- Glycemia(Day 1.)
- Ultra-sensitive C-reactive protein (us-CRP)(Day 1.)
- Hematocrit(Day 1.)
- 17-alpha-hydroxyprogesterone (17-OHP)(Day 1.)
- Dehydroepiandrosterone (DHEA)(Day 1.)
- Androstenedione(Day 1.)
- Free testosterone(Day 1.)
- Total testosterone(Day 1.)
- Estradiol(Day 1.)
- Follicle-stimulating hormone (FSH)(Day 1.)
- Luteinizing hormone (LH)(Day 1.)
- Sex hormone-binding globulin (SHBG)(Day 1.)
- Muscular strength(Day 1.)
研究者
研究点 (1)
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