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BECONTRA: Effects of combined oral contraceptives on brain and behavior
EU CTIS ID: 2024-519260-41-00
What this study is testing
The primary objective of this study is to identify and characterize the effects of the most commonly used oral contraceptives (EE/LNG; EE/CMA) on brain structure and function as well as behavior after up to 6 months of treatment and its reversibility upon withdrawal. The influence of age, type of oral contraceptive and other potential determinants of drug response will be analyzed.
- 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
- 14-35 years of age
- female
- General interest in the intake of COCs or current use of COCs containing EE/LNG or EE/CMA
- Regular menstrual cycle for at least 6 months according to the criteria of Fehring et al. (2006), i.e. a cycle duration of 21 to 35 days with a maximum deviation of 7 days between individual cycle lengths.
- Sufficient German language skills to follow task instructions
You likely can't join if
- contra-indication for use of EE/LNG or EE/CMA
- diagnosed psychiatric disorder with known effects on cognition or brain structure/function (e.g. schizophrenia, etc.). Exception: women with mild mood disorders (anxiety, depression) are included as long as no hospitalization occurred in the past 6 months
- diagnosed neurological disorder with known effects on cognition or brain structure/function (e.g. multiple sclerosis, epilepsy, etc.)
- diagnosed endocrinological disorder deemed clinically significant by the Investigator at screening (e.g. PCOS, Cushing's syndrome, congenital renal hyperplasia)
- regular intake of medication that might interfere with the conduct of the study or the interpretation of the results including, but not limited to: 5.1. medication with known interaction potential including but not limited to: A. drugs that can increase intestinal motility and thus reduce the resorption of the IMPs (e.g. metoclopramide) or impact the resorption directly (e.g. active carbon) or reduce entero hepatic circulation (ampicillin, tetracyclin) B. activators of hepatic microsomal enzymes like rifampicin, rifabutin, barbiturates, anticonvulsants (e.g. carbamacepine, phenytoine und topiramat), griseofulvin, barbexaclon, primidon, modafinil, some protease inhibitors (e.g. ritonavir) and St. John’s wort, C. inhibitors of microsomal enzymes like imidazol-antimykotics (e.g. Fluconazol), indinavir or troleandomycin, D. strong or moderate CYP3A4-Inhibitors like azol-antimycotics (e.g. itraconazol, voriconazol, fluconazol), verapamil, macrolide antibiotics (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice, which can increase plasma levels of estrogen or gestagen or both, BECONTRA Version 7 – 29/July/2024 Page 26 of 57 E. etoricoxib in doses of 60 to 120 mg/d, which can increase plasma ethinylestradiol under combined oral COCs, F. troleandomycin, which can induce intrahepatic cholestasis in co-administration with combined COCs, G. drugs who inhibit sulfatation of ethinylestradiol in enterocytes like ascorbic acid or paracetamol (acetamionophen), H. atorvastatin (increased AUC of ethinylestradiol by 20%). 5.2. drugs that impair cognitive function, including but not limited to hypnotics, benzodiazepines, anti-psychotics, anti-convulsants, anti-depressants, cns active anti-histamines. 5.3. Alcohol or drug abuse 5.4. cognitive stimulants or nootropics. 5.5. medication that might interfere with the conduct of the study or the interpretation of the results otherwise
- current pregnancy or previous pregnancies
See the full eligibility criteria
Who can join
- 14-35 years of age
- female
- General interest in the intake of COCs or current use of COCs containing EE/LNG or EE/CMA
- Regular menstrual cycle for at least 6 months according to the criteria of Fehring et al. (2006), i.e. a cycle duration of 21 to 35 days with a maximum deviation of 7 days between individual cycle lengths.
- Sufficient German language skills to follow task instructions
What rules you out
- contra-indication for use of EE/LNG or EE/CMA
- diagnosed psychiatric disorder with known effects on cognition or brain structure/function (e.g. schizophrenia, etc.). Exception: women with mild mood disorders (anxiety, depression) are included as long as no hospitalization occurred in the past 6 months
- diagnosed neurological disorder with known effects on cognition or brain structure/function (e.g. multiple sclerosis, epilepsy, etc.)
- diagnosed endocrinological disorder deemed clinically significant by the Investigator at screening (e.g. PCOS, Cushing's syndrome, congenital renal hyperplasia)
- regular intake of medication that might interfere with the conduct of the study or the interpretation of the results including, but not limited to: 5.1. medication with known interaction potential including but not limited to: A. drugs that can increase intestinal motility and thus reduce the resorption of the IMPs (e.g. metoclopramide) or impact the resorption directly (e.g. active carbon) or reduce entero hepatic circulation (ampicillin, tetracyclin) B. activators of hepatic microsomal enzymes like rifampicin, rifabutin, barbiturates, anticonvulsants (e.g. carbamacepine, phenytoine und topiramat), griseofulvin, barbexaclon, primidon, modafinil, some protease inhibitors (e.g. ritonavir) and St. John’s wort, C. inhibitors of microsomal enzymes like imidazol-antimykotics (e.g. Fluconazol), indinavir or troleandomycin, D. strong or moderate CYP3A4-Inhibitors like azol-antimycotics (e.g. itraconazol, voriconazol, fluconazol), verapamil, macrolide antibiotics (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice, which can increase plasma levels of estrogen or gestagen or both, BECONTRA Version 7 – 29/July/2024 Page 26 of 57 E. etoricoxib in doses of 60 to 120 mg/d, which can increase plasma ethinylestradiol under combined oral COCs, F. troleandomycin, which can induce intrahepatic cholestasis in co-administration with combined COCs, G. drugs who inhibit sulfatation of ethinylestradiol in enterocytes like ascorbic acid or paracetamol (acetamionophen), H. atorvastatin (increased AUC of ethinylestradiol by 20%). 5.2. drugs that impair cognitive function, including but not limited to hypnotics, benzodiazepines, anti-psychotics, anti-convulsants, anti-depressants, cns active anti-histamines. 5.3. Alcohol or drug abuse 5.4. cognitive stimulants or nootropics. 5.5. medication that might interfere with the conduct of the study or the interpretation of the results otherwise
- current pregnancy or previous pregnancies
- for MR group: contra-indication for MRI, including claustrophobia
- for MR group: brain tissue abnormalities on structural MRI as screened by a neuro-radiologist
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, 0-17 years, 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.