Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT06306404
Eligibility Criteria:
Inclusion Criteria:
* Age between 40-55 years old
* Insomnia severity index score =\>10
* Green Climacteric Score =\>13
* Self-considered capability of completing online questionnaires and diaries in Dutch/English
* Presence of a menstruation (whether regular or not) and the last menstruation must be less than 12 months ago
Exclusion Criteria:
* CBTi treatment in past year
* Bipolar disorder or psychotic disorder
* Contra-indication for Menopausal Hormone Therapy
* Alcohol or drugs dependency (scores of ≥ 20 on the AUDIT and ≥25 on the DUDIT)
* Women using thyroid medication, lamotrigine, aromatase, tamoxifen, because of interaction effects with MHT
* Use of drugs known to interfere with cytochrome P450 enzyme (CYP) 3A4
* Known hypersensitivity to the excipients in the estradiol patch: acrylate copolymer, polyethylene terephthalate, alfa-tocopherol, soy allergy (component of progesterone capsule).
* All women on hormonal contraceptives will be excluded.
* All women already on MHT will be excluded.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT06306404
Study Brief:
Protocol Section:
NCT06306404