Sleeping through menopause: a hormone therapy trial
Part of Brain & nervous system, Mental health clinical trials.
This trial tests whether menopausal hormone therapy can help women aged 40-55 who have trouble sleeping during the menopause transition. It aims to improve sleep using a patch and a pill, and you'll track your symptoms online.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are between 40 and 55 years old.
- You have significant trouble sleeping (Insomnia Severity Index score of 10 or more).
- You have moderate to severe menopause symptoms (Green Climacteric Score of 13 or more).
- You still have periods (regular or not) and your last period was less than a year ago.
- You can complete online questionnaires and diaries in Dutch or English.
- You have not had cognitive behavioral therapy for insomnia (CBTi) in the past year, and you do not have bipolar disorder or a psychotic disorder.
- You are not using hormonal contraceptives, menopausal hormone therapy, or certain medications (like thyroid drugs, lamotrigine, aromatase inhibitors, tamoxifen, or drugs affecting CYP3A4).
- You do not have a soy allergy or a known allergy to the patch ingredients, and you have no alcohol or drug dependency issues.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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