CTIS2023-507842-10-00进行中（未招募）1 期
Brain effects of hormonal contraceptives. A randomized, double-blind, longitudinal study comparing two combined oral contraceptives (Estetrol/drospirenone vs ethinylestradiol/levonorgestrel).
Region Uppsala0 个研究点目标入组 60 人开始时间: 2023年10月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •–be essentially healthy, –in need of contraception, i.e. sexually active, –be a woman between 18-35 years of age (i.e. =18 and <36 years), –have a regular menstrual cycle (25-31 days) in the opinion of the investigator
排除标准
- •–History of venous thromboembolism (VTE), or first-degree relatives with a history of VTE, –Previous or ongoing pancreatitis, –Ongoing severe liver disease, or liver tumor, –Renal insufficiency or severe kidney disease, –Type 1 diabetes with vascular complications, –Severe dyslipidemia, –Migraine with aura, –Vaginal bleeding of unknown origin, –Oral cortisone treatment during the previous 3 months., –Treatment with antidepressive- or antipsychotic drugs or other psychopharmaceuticals during the previous 3 months., –Ongoing psychiatric disease, –Genetic or acquired predisposition for venous or arterial thrombosis including activated protein C resistance, anti-thrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia or anti-phospholipid antibodies, –Premenstrual dysphoric syndrome according to daily symptom ratings on the DRSP scale, –Severe medical conditions in the opinion of the investigator that may interfere with compliance to treatment or study procedures, –Breast-feeding, pregnancy or plans of a pregnancy during the study period, –Concurrent participation in any other clinical trial, –Hearing impairments or visual impairment (> 5 degrees myopic/hyperopic or profound astigmatism), –Profound fear of confined spaces, –Other contraindications for magnetic resonance imaging, –Major planned surgery, requiring immobilization., –High risk for VTE due to multiple risk factors, –Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening, –Previous or ongoing atherosclerosis such as coronary artery disease, myocardial infarction, stroke or transient ischemic attack, –BMI > 30.0 kg/m2, –Parents diagnosed with myocardial infarction or stroke (before the age of 55 in father and before the age of 65 in mother), –Previous hormone-sensitive cancer, like breast cancer, endometrial cancer or ovarian cancer
研究者
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