2023-507842-10-00招募中4 期
Brain effects of hormonal contraceptives. A randomized, double-blind, longitudinal study comparing two combined oral contraceptives (Estetrol/drospirenone vs ethinylestradiol/levonorgestrel).
Region Uppsala3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月18日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change from baseline to treatment in grey matter volume grey matter surface and gyrification, white matter integrity and connectivity (DTI), resting state activity and reactivity during emotion processing
研究概览
简要总结
To establish if the combined hormonal contraceptives E4/DRSP and EE/LNG have differential effects on brain structure and function.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
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
结局指标
主要结局
Change from baseline to treatment in grey matter volume grey matter surface and gyrification, white matter integrity and connectivity (DTI), resting state activity and reactivity during emotion processing
Change from baseline to treatment in grey matter volume grey matter surface and gyrification, white matter integrity and connectivity (DTI), resting state activity and reactivity during emotion processing
次要结局
- Change in DRSP score between baseline and treatment
- Change in Quality of Life between baseline and treatment
- Change in depressive symptoms and anxiety symptoms from baseline
研究者
Inger Sundström Poromaa
Scientific
Region Uppsala
研究点 (3)
Loading locations...
相似试验
招募中
4 期
BECONTRA: Effects of combined oral contraceptives on brain and behavior2024-519260-41-00Paris Lodron Universitaet Salzburg600
进行中（未招募）
1 期
Brain effects of hormonal contraceptives.ContraceptionMedDRA version: 22.0Level: PTClassification code: 10073728Term: Hormonal contraception Class: 100000004865CTIS2023-507842-10-00Region Uppsala60
终止
3 期
Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen AllergyNCT07309432Regeneron Pharmaceuticals24
已完成
2 期
E4/DRSP Ovarian Function Inhibition StudyPrevention of PregnancyNCT03091595Estetra82
已完成
2 期
Alii Supplement StudyNCT07271316Texas Christian University16