CHLORMADINONE ACETATE, ETHINYLESTRADIOL for Hormonal contraception

Inclusion criteria

• {"criterion_text":"- 14-35 years of age"}
• {"criterion_text":"- female"}
• {"criterion_text":"- General interest in the intake of COCs or current use of COCs containing EE/LNG or EE/CMA"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Sufficient German language skills to follow task instructions"}

Exclusion criteria

• {"criterion_text":"- contra-indication for use of EE/LNG or EE/CMA"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- diagnosed neurological disorder with known effects on cognition or brain structure/function (e.g. multiple sclerosis, epilepsy, etc.)"}
• {"criterion_text":"- diagnosed endocrinological disorder deemed clinically significant by the Investigator at screening (e.g. PCOS, Cushing's syndrome, congenital renal hyperplasia)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- current pregnancy or previous pregnancies"}
• {"criterion_text":"- for MR group: contra-indication for MRI, including claustrophobia"}
• {"criterion_text":"- for MR group: brain tissue abnormalities on structural MRI as screened by a neuro-radiologist"}

Primary endpoints

• {"endpoint_text":"- Mood and self-perception (Premenstrual symptoms, Positive and negative affect, depression, Anxiety, Gender Role)","definition_or_measurement_approach":"Mood and self-perception assessed by measures of premenstrual symptoms, affect scales, depression and anxiety scales, and gender role measures (detailed instruments not specified in JSON)."}
• {"endpoint_text":"- Cognition (Face recognition, verbal fluency, navigation, working memory)","definition_or_measurement_approach":"Cognition assessed using tasks including face recognition, verbal fluency, navigation, and working memory tests (specific test instruments not specified in JSON)."}
• {"endpoint_text":"- Brain structure","definition_or_measurement_approach":"Brain structure assessed by neuroimaging (MRI) as implied by MR group references and structural MRI screening; specific imaging measures not detailed in JSON."}
• {"endpoint_text":"- Brain function","definition_or_measurement_approach":"Brain function assessed by functional imaging or neurophysiological measures (specific modalities not detailed in JSON)."}

Secondary endpoints

• {"endpoint_text":"- sex hormone levels (estradiol, progesterone, allopregnanolone, testosterone dihydrotestosterone, LH, FSH, Prolactin, SHBG)","definition_or_measurement_approach":"Measured as blood hormone assays (specific assay methods not provided in JSON)."}
• {"endpoint_text":"- stress hormone levels (cortisol, ACTH)","definition_or_measurement_approach":"Measured as blood (or saliva) assays for cortisol and ACTH (specifics not provided in JSON)."}
• {"endpoint_text":"- levels of interventional drugs (Ethinylestradiol, Levonorgestrel, Chlormadinonacetate)","definition_or_measurement_approach":"Measured via blood drug level assays (specific pharmacokinetic methods not provided in JSON)."}
• {"endpoint_text":"- Genetic variants (repeat polymorphism or SNP) of steroid hormone receptors (AR, ESR1, ESR2, PGR, MR) targeted by the interventional drugs","definition_or_measurement_approach":"Genotyping for repeat polymorphisms or SNPs in listed genes."}
• {"endpoint_text":"- Genetic variants of genes (repeat polymorphism or SNP) involved in neurotransmitter systems (COMT, MAOA, 5HTT, 5HTR, BDNF) responsive to sex hormones","definition_or_measurement_approach":"Genotyping for repeat polymorphisms or SNPs in listed genes."}

Austria

Earliest CTIS Part Ii Submission Date

15-11-2024

Latest Decision Or Authorization Date

09-12-2024

Processing Time Days

24

Number Of Sites

2

Number Of Participants

600

Primary sponsor

Full Name

Paris Lodron Universitaet Salzburg

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"European Research Council (ERC)","duties_or_roles":"Source of monetary support","organisation_type":""}