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Brain effects of hormonal contraceptives.
EU CTIS ID: 2023-507842-10-00
What this study is testing
To establish if the combined hormonal contraceptives E4/DRSP and EE/LNG have differential effects on brain structure and function.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- – 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
You likely can't join if
- – 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
See the full eligibility 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
- – 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.