Brain effects of hormonal contraceptives.

Recruitment & Eligibility

Status: Not Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

–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

Exclusion Criteria

–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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish if the combined hormonal contraceptives E4/DRSP and EE/LNG have differential effects on brain structure and function.;Secondary Objective: Change in quality of life, Change in depressive and anxiety symptoms;Primary end point(s): 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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change in DRSP score between baseline and treatment;Secondary end point(s):Change in Quality of Life between baseline and treatment;Secondary end point(s):Change in depressive symptoms and anxiety symptoms from baseline