Effects of Hormone Replacement Therapy on Sleep in the Peri- and Postmenopause
Summary description of the study
Women are known to have more difficulties than men in initiating and maintaining satisfactory sleep, which is exacerbated during times of hormonal changes such as during pregnancy or in the peri- and postmenopause. With our study, we aim to determine the effect of an individually tailored and medically indicated menopausal hormone therapy (MHT) on various sleep parameters in peri- and postmenopausal women.
(BASEC)
Intervention under investigation
The study will include 172 women (86 peri- and 86 postmenopausal women). There is no specific study-related MHT, but all MHT preparations approved by Swissmedic may be used based on an individual and patient-centered choice by the treating physician. Participants will be divided into two groups based on their menopausal status - one peri- and one postmenopausal group - and will then be randomized 2:1 into an intervention group (start of MHT after 2 weeks) and a control group (start of MHT with a delay of an additional 6-8 weeks). All participants will be asked to complete questionnaires as well as a sleep diary before and after the start of MHT. For the control group, this will also occur once more during the waiting period until the start of MHT.
(BASEC)
Disease under investigation
Sleep disorders
(BASEC)
- Signed informed consent - Peri- and postmenopausal woman - Indication for MHT (e.g., climacteric syndrome, osteoporosis, etc.) - Age ≥ 18 years - German-speaking (BASEC)
Exclusion criteria
- Pregnancy or lactation - BMI ≥ 30 kg/m² - Status after hysterectomy - Systemic hormone therapy or hormonal contraception (estrogens, progestins, androgens) during the study and within 12 weeks prior to the start of the study - Prescribed medications for the treatment of sleep problems 12 weeks prior to the start of the study (excluding phytotherapeutics and over-the-counter medications) - Medications that could disturb sleep (e.g., antidepressants, anticonvulsants, and antipsychotic medications) - Substance abuse (e.g., daily alcohol consumption, drugs in general) - Contraindications for hormone therapy in menopause according to swissmedicinfo.ch - Known or suspected non-compliance due to inability to follow the study procedures (e.g., illiteracy, language problems, mental disorders, dementia, etc.) (BASEC)
Trial sites
Basel, Bern, Zurich
(BASEC)
Sponsor
Susanna Weidlinger
(BASEC)
Contact
Contact Person Switzerland
Susanna Weidlinger
+41 31 632 13 03
susanna.weidlinger@clutterinsel.chAbtl. für Gynäkologische Endokrinologie und Reproduktionsmedizin Universitätsklinik für Frauenheilkunde Inselspital Bern Friedbühlstrasse 19 CH - 3010 Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
16.05.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Effect of menopausal hormone therapy on sleep (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
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Type of trial
not available
Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available