Progesterone, micronised for Insomnia|Climacteric symptoms

Inclusion criteria

• {"criterion_text":"- Age between 40-55 years old"}
• {"criterion_text":"- Insomnia severity index score =>10"}
• {"criterion_text":"- Green Climacteric Score =>13"}
• {"criterion_text":"- Self-considered capability of completing online questionnaires and diaries in Dutch and English"}
• {"criterion_text":"- Presence of a menstrual cycle (<1yr since last menstruation)"}

Exclusion criteria

• {"criterion_text":"- CBTi treatment in past 3 months"}
• {"criterion_text":"- Bipolar disorder or psychotic disorder"}
• {"criterion_text":"- Contra-indication for Menopausal Hormonal Therapy"}
• {"criterion_text":"- Use of hormonal contraceptives"}
• {"criterion_text":"- Women using thyroid medication of lamotrigine"}
• {"criterion_text":"- Women already on MHT"}

Primary endpoints

• {"endpoint_text":"- The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline). Insomnia severity will be assessed with the Insomnia Severity Index (ISI) (Bastien et al., 2001) at these three timepoints.","definition_or_measurement_approach":"Insomnia severity assessed with the Insomnia Severity Index (ISI) at baseline (T0), 2 months (T1) and 4 months (T2); primary outcome is between-group difference in within-subject change in ISI at T1 and T2 relative to T0."}

Secondary endpoints

• {"endpoint_text":"- Other sleep outcomes: subjective sleep efficiency (sleep diary), objective sleep efficiency, REM sleep fragmentation (EEG headband).","definition_or_measurement_approach":"Subjective sleep efficiency from sleep diary; objective sleep efficiency and REM sleep fragmentation measured with headband EEG."}
• {"endpoint_text":"- Depressive symptoms: IDS-SR","definition_or_measurement_approach":"Depressive symptoms measured by the IDS-SR questionnaire."}
• {"endpoint_text":"- Other mental health outcomes: RMT-20, PMH scale, MHQoL, EuroQoL","definition_or_measurement_approach":"Measured using listed validated instruments: RMT-20, PMH scale, MHQoL and EuroQoL questionnaires."}
• {"endpoint_text":"- Wellbeing and daytime functioning: PLB, Cantrill's ladder","definition_or_measurement_approach":"Wellbeing and daytime functioning assessed by PLB and Cantrill's ladder of life instruments."}
• {"endpoint_text":"- Climacteric symptoms: GCS, HFRDIS, objective frequency hotflushes (watch)","definition_or_measurement_approach":"Climacteric symptoms assessed by Green Climacteric Scale (GCS), HFRDIS and objective hotflush frequency from wearable (watch)."}
• {"endpoint_text":"- Individual differences: Sleep history (questionnaire), CTQ, PSST, EPDS","definition_or_measurement_approach":"Individual differences assessed using sleep history questionnaire, CTQ, PSST and EPDS instruments."}

Netherlands

Earliest CTIS Part Ii Submission Date

05-03-2025

Latest Decision Or Authorization Date

05-07-2025

Processing Time Days

122

Number Of Sites

2

Number Of Participants

222

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands