No More Sleepless Nights in Perimenopause
Recruiting
Phase 4
Interventional Study
Insomnia
Menopause
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 45 – 69
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 54 (estimated)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Other
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About This Trial
The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are:
* Are HRT and CBT-I effective in reducing insomnia in menopausal women?
* Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population?
Researchers will compare HRT and …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
* Pittsburgh Sleep Quality Index (PSQI) score \> 5
* Insomnia Severity Index (ISI) score \> 7
* Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
* Willingness to …
Contacts