The study investigates perimenopausal symptoms (ICD-10: N95.1) in women aged 40 to 55 years in late perimenopause (amenorrhea = 60 days, according to STRAW criteria). Climacteric symptoms such as hot flashes, night sweats, and sleep disturbances are assessed using the Menopause Rating Scale (MRS). Women in postmenopause as well as those with surgically or medically induced menopause are excluded at study baseline. N95.1
Conditions
Interventions
Group 1: This monocentric, prospective observational study investigates the effects of the perimenopause on brain and mental health using an integrated biopsychosocial approach over a period of three
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
Female
Age
40 Years to 55 Years
Inclusion criteria
Inclusion criteria: - Late perimenopausal (i.e. amenorrhoea of at least 60 days according to STRAW criteria) - Perimenopausal symptoms (e.g. hot flushes, night sweats, sleep disturbances, etc., assessed by standardised questionnaire, MRS) - Written informed consent to participate in the study - Existing health insurance
Exclusion criteria
Exclusion criteria: - Use of hormonal contraceptives - Use of hormone replacement therapy at study entry (initiation during the study is not an exclusion or discontinuation criterion) - Pregnancy - Hysterectomy and/or bilateral oophorectomy, or other surgical interventions leading to permanent cessation of menstruation - Conditions associated with irregular menstrual cycles, such as polycystic ovary syndrome - Physical illnesses that, by nature or severity, may interfere with the planned assessments or influence the parameters under investigation (e.g. focal neurological disorders, cancer, cardiac or pulmonary disease, renal disease, chronic pain conditions) - Currently manifest psychiatric disorders (e.g. substance dependence (excluding nicotine), schizophrenia, bipolar disorder) - Psychotropic medication - Substance misuse or illicit drug use - History of moderate or severe head trauma requiring hospitalisation - Neurological conditions (e.g. brain tumour, stroke) that may affect brain structure or function - MRI contraindications (e.g. metal implants or devices such as cardiac pacemakers, claustrophobia, sensorineural hearing loss of 30 dB or above, tinnitus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The current project is based on one main objective and three sub-objectives, all derived from a biopsychosocial framework. The main objective is to determine the temporal dynamics of brain and mental health changes during the perimenopause, assessed by the following outcome measures: 1. Brain structural and functional changes (morphometry, functional connectivity, white matter microstructure) – Time points: Baseline, 18 months, 36 months – Assessment: Multimodal 3-Tesla magnetic resonance imaging (T1, T2, MPM, pCASL, DWI, resting-state fMRI; max. 60 min/session) 2. Perimenopausal symptom burden – Time points: Baseline, 6, 12, 18, 24, 30, 36 months; continuously – Assessment: e.g. Menopause Rating Scale (MRS, REDCap); Clue App – Perimenopause Mode (daily) 3. Severity of mental health burden – Time points: Baseline, 6, 12, 18, 24, 30, 36 months – Assessment: e.g. PHQ-9, Meno-D (REDCap); Mini-DIPS interview (baseline) Sub-Objective 1 aims to determine the effects of biological changes during the perimenopause on female brain and mental health. The hypothesis is that hormonal changes, immune factors, and gut microbiota are associated with the severity of perimenopausal symptoms, including mood changes, and the extent of brain changes during the perimenopause. The outcome measures are as follows: 4. Hormonal parameters (multi-steroid panel, including estradiol, progesterone, FSH, LH, testosterone) – Time points: Baseline, 6, 12, 18, 24, 30, 36 months – Assessment: Blood draw (serum); LC-MS/MS analysis 5. Immunological parameters (including cytokines) – Time points: Baseline, 6, 12, 18, 24, 30, 36 months – Assessment: Blood draw (EDTA); immunoassay/multiplex analysis 6. HPA axis activity (cortisol as an indicator of chronic stress) – Time points: Baseline, 18 months, 36 months – Assessment: Hair sample (proximal segment); LC-MS/MS analysis 7. Gut microbiota composition and diversity – Time points: Baseline, 18 months, 36 months – Assessment: Stool sample (self- | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective 1 – Big data analyses and international consortium To strengthen the reliability and broader applicability of the findings, study data will be compared and analysed together with health data from large population-based studies, such as the UK Biobank, which holds data from hundreds of thousands of people. MappingPerimenopause is also part of an international research network in which scientists worldwide pool and jointly analyse brain data (the ENIGMA consortium). The principal investigator leads the working group on hormones, brain health, and menopause within this network. Secondary Objective 2 – Spin-Off: Hormone Replacement Therapy (HRT, where applicable) Participants who begin hormone replacement therapy during the course of the study are not excluded. The initiation, type of preparation, dosage, route of administration, and satisfaction with symptom management are prospectively documented and incorporated into statistical analyses as a covariate as well as in dedicated subgroup analyses. Effect of HRT initiation on biological, neurological and psychiatric parameters – Time points: Continuously; analysed as a covariate and in subgroup analyses at all assessment time points – Assessment: Prospective documentation of initiation, type of preparation, dosage, route of administration, and satisfaction with symptom management (REDCap) | — |
Countries
Germany
Contacts
Public ContactClaudia Barth
Charité - Universitätsmedizin Berlin
Outcome results
None listed