Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
222
Countries
1
Sites
2
Insomnia
This study aims to evaluate effectiveness of stand alone MHT and a guided online CBTi with CRS on insomnia and depressive symptoms in perimenopausal women. Additionally, the added effect of a combination of MHT and guided online CBTi and CRS will be evaluated on the same outcome measurements. This study aims to amelior…
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 29 Oct 2025 → ongoing
- Decision date (initial)
- 2025-03-21
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Menopause Consortium
External identifiers
- EU CT number
- 2024-512071-12-00
- ClinicalTrials.gov
- NCT06306404
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
This study aims to evaluate effectiveness of stand alone MHT and a guided online CBTi with CRS on insomnia and depressive symptoms in perimenopausal women. Additionally, the added effect of a combination of MHT and guided online CBTi and CRS will be evaluated on the same outcome measurements. This study aims to ameliorate mental health complaints and improve well-being in perimenopausal women.
Secondary objectives 6
- Is CBTi + CRS or MHT, or a combination of both effective in improving other sleep quality indicators, as indicated by reducing subjective (sleep diary) and objective (headband EEG) insomnia symptoms and improving overnight dissolving of distress?
- Is CBTi + CRS or MHT, or a combination of both effective in reducing the severity of depressive symptoms, as indicated by reduced symptoms of depression on a validated depression questionnaire?
- Is CBTi + CRS or MHT, or a combination of both effective in reducing the severity of mental health complaints within the diagnostic dimensions of panic disorder, social anxiety, generalized anxiety, PTSD?
- Is CBTi + CRS or MHT, or a combination of both effective in improving wellbeing and daytime functioning as indicated by reduced use of care and improved health behaviours that support mental resilience, like enhanced physical activity, stress coping and bedtime regularity, and reduced smoking and alcohol use?
- Is CBTi + CRS able to enhance subsequent treatment responsiveness to MHT, as assessed by climacteric symptom severity at follow up?
- What are the associations between participant characteristics (sleep and health history, traits, hormonal sensitive depression) and current sleep, mental health and climacteric symptoms?
Conditions and MedDRA coding
Insomnia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 and English
- Presence of a menstrual cycle (<1yr since last menstruation)
Exclusion criteria 6
- CBTi treatment in past 3 months
- Bipolar disorder or psychotic disorder
- Contra-indication for Menopausal Hormonal Therapy
- Use of hormonal contraceptives
- Women using thyroid medication of lamotrigine
- Women already on MHT
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 6
- Other sleep outcomes: subjective sleep efficiency (sleep diary), objective sleep efficiency, REM sleep fragmentation (EEG headband).
- Depressive symptoms: IDS-SR
- Other mental health outcomes: RMT-20, PMH scale, MHQoL, EuroQoL
- Wellbeing and daytime functioning: PLB, Cantrill's ladder
- Climacteric symptoms: GCS, HFRDIS, objective frequency hotflushes (watch)
- Individual differences: Sleep history (questionnaire), CTQ, PSST, EPDS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Systen 50, pleisters voor transdermaal gebruik 50 microgram/24 uur
PRD8308806 · Product
- Active substance
- Estradiol
- Pharmaceutical form
- TRANSDERMAL PATCH
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 50 µg microgram(s)
- Max total dose
- 50 µg microgram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- RVG 16080
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD550472 · Product
- Active substance
- Progesterone, Micronised
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- RVG 11473
- MA holder
- BESINS HEALTHCARE NETHERLANDS BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Prof. dr. Birit Broekman
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Prof. dr. Birit Broekman
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 222 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-10-29 | 2025-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 36 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2024-512071-12-00_Redacted | 8 |
| Protocol (for publication) | D1 Technical addendum sample size calculation | 2 |
| Protocol (for publication) | D4_Participant facing documents questionnaire SF-12 | 1 |
| Protocol (for publication) | D4_Patient facing documents Logbook EEG headband | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire AUDIT | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Cantrills ladder of life | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire CTQ | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire DSM Insomnia | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire DUDIT | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Edinburgh Postnatal Depression Scale-Lifetime | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Expectancy questions | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire GAD-7 | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire GCS | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire HFRDIS | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire IDS-SR | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire ISI | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Munich Chronotype Questionnaire | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire PMH scale | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire PSST | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Reduced Morningness Eveningness Questionnaire | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Screener | 3 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Sleep diary | 2 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Sleep diary - evening | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Symptoms of sleep disorders other than insomnia | 1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire Treatment Satisfaction | 2 |
| Protocol (for publication) | D4_Patientfacing documents questionnaire Online Baseline Survey | 2 |
| Protocol (for publication) | FG Advies Empatica en Hypnodyne | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material brochure NL | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material flyer NL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Redacted | 5 |
| Subject information and informed consent form (for publication) | Translation certificate Taalcentrum VU | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Systen 50 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Utrogestan | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2024-512071-12-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-512071-12-00 | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-21 | Netherlands | Acceptable with conditions 2025-03-17
|
2025-03-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-22 | Netherlands | Acceptable 2025-07-05
|
2025-07-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-09 | Netherlands | Acceptable 2025-10-22
|
2025-10-22 |