BECONTRA - Effects of combined oral contraceptives on brain and behavior - BECONTRA

niversität Salzburg0 个研究点目标入组 600 人开始时间: 2020年4月10日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•1.Girls and women 14 years - 35 years,
•2.considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs, with a
•3.regular menstrual cycle for at least 6 months according to the criteria of Fehring et al. (2006) and
•4.sufficient German language skills to follow task instructions
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 350
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Known contra-indication to use of EE/LNG or EE/CMA COCs,
•2. diagnosed psychiatric disorder with known effects on cognition or brain structure/function (e.g. schizophrenia, etc.) with the exception of mood disorders
•3. diagnosed neurological disorder with known effects on cognition or brain structure/function (e.g. multiple sclerosis, epilepsy, etc.)
•4. diagnosed endocrinological disorder deemed clinically significant by the Investigator at screening (e.g. PCOS, Cushing's syndrome, congenital renal hyperplasia)
•5. regular intake of medication that might interfere with the conduct of the study or the interpretation of the results (defined below)
•6. current pregnancy or previous pregnancies
•7. for MR group: contra-indication for MRI
•8. for MR group: brain tissue abnormalities on structural MRI as screened by a neuro-radiologist

发起方

niversität Salzburg