MappingPerimenopause
Are you between 40 and 55 years old and have you noticed that your periods have been irregular for more than two months? Do you also experience symptoms such as hot flashes or night sweats, sleep disturbances, and forgetfulness?
These could be signs of perimenopause - and you’ve come to the right place.
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About the Study
Menopause is a significant phase of life for most women, associated with considerable physical and emotional changes. Perimenopause in particular - the transitional period leading up to the last menstrual period - is a phase during which many women notice first changes: hot flashes, night sweats, sleep disturbances, mood swings, or memory changes are common symptoms. Science is only now beginning to understand what happens in the brain during this time and that is exactly what we want to explore with MappingPerimenopause.
By participating, you’ll help change that. Over the course of three years, we’ll work with you to investigate how perimenopause affects the brain and mental health. At three points in time - at the start of the study, after 1.5 years, and after 3 years - you’ll undergo brain imaging via magnetic resonance imaging (MRI) and neurocognitive testing; stool and hair samples will also be collected. Every six months, blood samples as well as clinical and psychosocial data will be collected. Perimenopausal symptoms will be continuously recorded via the Clue app, conveniently from home.
Our shared goal is to better understand perimenopause as a neurobiological transition phase and thereby lay the groundwork for targeted prevention and treatment strategies that will benefit future generations of women.
The study will last a total of 3 years (see figure for an overview). During this time, we will provide ongoing support and will be available at any time to answer questions or address concerns. A total of 7 appointments are scheduled: three main examinations and four semi-annual follow-up appointments. The duration of the appointments ranges from about 30 minutes to a maximum of 5 hours for the main examinations.
Main examinations: During the three main examinations - at the start of the study, after approximately 1.5 years, and after 3 years - we will perform the following tests, among others:
- MRI of your brain (without contrast agent): We will examine the structure and function of the brain using various techniques, such as structural and diffusion-weighted imaging, as well as resting-state functional MRI. An MRI session lasts a maximum of 60 minutes and is performed at the BCAN (Berlin Center for Advanced Neuroimaging, Charité - Universitätsmedizin, Sauerbruchweg 4, 10117 Berlin) by medical technologists.
- Blood samples: Approximately 40 ml of blood is drawn (equivalent to about 4 tablespoons). Blood draws take place in the morning on an empty stomach to minimize fluctuations throughout the day. We use the blood samples to examine, among other things, your hormone levels as well as parameters of the immune, cardiovascular, and metabolic systems. The hormone levels also help us assess your current stage of perimenopause.
- Stool and hair samples: You will collect stool samples (about the size of a hazelnut) yourself at home shortly before the MRI scan. Hair samples (a strand of hair, taken close to the scalp) will be collected by trained staff. These samples help us examine, among other things, the composition of your gut microbiome as well as the activity of your body’s stress axis (HPA axis).
- Neurocognitive tests and questionnaires: We assess memory, concentration, mood, and well-being. The tests and questionnaires can be completed either on paper or via the online tool REDCap. You can complete the questionnaires flexibly on-site or conveniently from home.
- Anthropometric measurements: We record body weight, height, waist circumference, blood pressure, and your current medication use. This data gives us a comprehensive picture of your overall health and any potential changes during menopause.
Semi-annual check-ups: During the four check-ups, which take place every six months between the main examinations, we will take blood samples, perform anthropometric measurements, and have you fill out questionnaires. This allows us to continuously monitor changes in your hormone levels, your physical and mental health, and your overall well-being.
App documentation: To track your symptoms and daily experiences as accurately as possible, use the Clue menstrual cycle app in perimenopause mode.
You will not receive any expense reimbursement!
As a participant in the study, you will receive free access to Clue Premium for 3 years. Clue allows you to track symptoms prospectively and thus gain personal insights into your experiences surrounding perimenopause. In addition, you will have access to scientifically sound health content on the topic of perimenopause and visualizations of your hormone profiles over time.
Food will be provided on the MRI scan days.
In addition, we invite you once a year to a “Menopause Coffee Hour” with coffee and cake: featuring short presentations, journalist-moderated discussion panels, and open conversation about menopause.
Studienleitung
Head of Research Division Neurobiology of Hormonal Transitions
