2024-519260-41-00招募中4 期
Effects of combined oral contraceptives on brain and behavior
Paris Lodron Universitaet Salzburg2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年12月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Mood and self-perception (Premenstrual symptoms, Positive and negative affect, depression, Anxiety, Gender Role)
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •14-35 years of age
- •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
排除标准
- •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.
- •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.
- •drugs that impair cognitive function, including but not limited to hypnotics, benzodiazepines, anti-psychotics, anti-convulsants, anti-depressants, cns active anti-histamines. 5.
- •Alcohol or drug abuse 5.
- •cognitive stimulants or nootropics. 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
结局指标
主要结局
Mood and self-perception (Premenstrual symptoms, Positive and negative affect, depression, Anxiety, Gender Role)
Mood and self-perception (Premenstrual symptoms, Positive and negative affect, depression, Anxiety, Gender Role)
Cognition (Face recognition, verbal fluency, navigation, working memory)
Cognition (Face recognition, verbal fluency, navigation, working memory)
Brain structure
Brain structure
Brain function
Brain function
次要结局
- sex hormone levels (estradiol, progesterone, allopregnanolone, testosterone dihydrotestosterone, LH, FSH, Prolactin, SHBG)
- stress hormone levels (cortisol, ACTH)
- levels of interventional drugs (Ethinylestradiol, Levonorgestrel, Chlormadinonacetate)
- Genetic variants (repeat polymorphism or SNP) of steroid hormone receptors (AR, ESR1, ESR2, PGR, MR) targeted by the interventional drugs
- Genetic variants of genes (repeat polymorphism or SNP) involved in neurotransmitter systems (COMT, MAOA, 5HTT, 5HTR, BDNF) responsive to sex hormones
研究者
Belinda Pletzer
Scientific
Paris Lodron Universitaet Salzburg
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
Brain effects of hormonal contraceptives.ContraceptionMedDRA version: 22.0Level: PTClassification code: 10073728Term: Hormonal contraception Class: 100000004865CTIS2023-507842-10-00Region Uppsala60
进行中（未招募）
1 期
BECONTRA - Effects of combined oral contraceptives on brain and behaviorGirls and women 14 years - 35 years, considering the intake of COCs or under current use of EE/LNG or EE/CMA COCsMedDRA version: 21.1Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10010808Term: ContraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 22.0Level: PTClassification code 10073728Term: Hormonal contraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2020-000790-24-ATniversität Salzburg600
招募中
不适用
The Pill Project - Oral Contraceptive and Serotonergic Brain SignalingSexual BehaviorMood DisturbanceMood ChangeAffect AlteredAffect BluntedDrug MechanismMajor Depressive DisorderNCT05212389Rigshospitalet, Denmark40
进行中（未招募）
不适用
ltrasound treatment of gluteal cellulitis in women who use and do not use oral contraceptivesDiseases of the skin and subcutaneous tissueL00-L99RBR-7yft5yniversidade do Estado de Santa Catarina
已完成
不适用
The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeasesChronic Venous DiseasesNCT04451746Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia116