Progesterone, micronised for Menopausal (climacteric) symptoms

Inclusion criteria

• {"criterion_text":"- Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH > 40 IE/L) with climacteric symptoms (sweating, hot flush and sleep problems) that adversely affect quality of life."}
• {"criterion_text":"- Age 45-60 years"}
• {"criterion_text":"- BMI > 19 kg/m2 and ≤ 32 kg/m2"}
• {"criterion_text":"- Intact uterus"}
• {"criterion_text":"- In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local estrogen treatment before screening"}
• {"criterion_text":"- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Previous history or risk factors for breast cancer, breast cancer in situ or abnormal mammogram at baseline as assessed clinically by a radiology expert"}
• {"criterion_text":"- Previous history or risk factors for endometrial cancer or hyperplasia or abnormal/proliferative endometrial biopsy at baseline"}
• {"criterion_text":"- Vaginal bleeding"}
• {"criterion_text":"- Any concomitant medical treatment except for well-controlled hypertension, non-insulin treated type 2 diabetes, asthma and hypothyroidism"}
• {"criterion_text":"- History or presence of or risk factor for cardiovascular disease including thromboembolic disorder or cerebrovascular disease"}
• {"criterion_text":"- History or presence of liver and gallbladder disease, familial hyperlipidemia, epilepsy or classical migraine with aura"}
• {"criterion_text":"- History or presence of clinically significant depression or other psychiatric disorder that might in anyway compromise the performance of the trial or undermine its scientific validity"}
• {"criterion_text":"- Porphyria, Systemic lupus erythematosus and otosclerosis"}
• {"criterion_text":"- Current use of MHT or local estrogen treatment"}
• {"criterion_text":"- Alcohol and/or drug abuse"}
• {"criterion_text":"- Hypersensitivity to any of the study treatments"}
• {"criterion_text":"- Clinically significant findings on physical and/or gynecological examination at baseline"}

Primary endpoints

• {"endpoint_text":"- Percentage change in mammographic density compared between the groups.","definition_or_measurement_approach":"Measured as percentage change in mammographic breast density between treatment groups; assessed by mammography after one year of treatment (Part 1, double-blind randomized comparison)."}

Secondary endpoints

• {"endpoint_text":"- Incidence of endometrial proliferation (proliferation marker (Ki67)","definition_or_measurement_approach":"Assessed by histological/proliferation marker Ki67 in endometrial tissue."}
• {"endpoint_text":"- Endometrial thickness on ultrasound","definition_or_measurement_approach":"Measured by transvaginal ultrasound to determine endometrial thickness."}
• {"endpoint_text":"- Bleeding pattern as documented in a bleeding diary","definition_or_measurement_approach":"Participant-recorded bleeding diary documenting bleeding patterns over treatment period."}
• {"endpoint_text":"- Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue","definition_or_measurement_approach":"Molecular analysis (gene and protein expression assays) on breast and endometrial tissue samples."}
• {"endpoint_text":"- Depression and anxiety symptoms (Patient Health Questionnaire (PHQ-9), Hospital Anxiety and Depression Scale (HADS))","definition_or_measurement_approach":"Validated questionnaires PHQ-9 and HADS to assess depression and anxiety symptoms."}
• {"endpoint_text":"- Health-related quality of life (Psychological General Well-Being Index (PGWB))","definition_or_measurement_approach":"Assessed using the Psychological General Well-Being Index (PGWB) questionnaire."}
• {"endpoint_text":"- Women’s Health Questionnaire (WHQ)","definition_or_measurement_approach":"Assessed using the Women’s Health Questionnaire (WHQ)."}
• {"endpoint_text":"- Blood lipid profile, serum hormones, growth and metabolic factors (follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, sex hormone-binding globulin, IGF–I and its binding proteins), and coagulation factors (antitrombin, factor V Leiden, factor II mutation, cardiolipin-ab, Lupus anticoagulant, Protein C activity, Protein S free, APT-time, fibrinogen, prothrombin complex, thrombocytes).","definition_or_measurement_approach":"Laboratory blood tests measuring lipid profile, specified serum hormones, growth/metabolic markers and listed coagulation factors/mutations per standard laboratory assays."}

Sweden

Earliest CTIS Part Ii Submission Date

30-12-2024

Latest Decision Or Authorization Date

17-01-2025

Processing Time Days

18

Number Of Sites

3

Number Of Participants

520

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden