TRIPTORELIN for Menopause

Inclusion criteria

• {"criterion_text":"-Women >40 years and ≤65 at screening visit"}
• {"criterion_text":"-A body mass index between 18-35"}
• {"criterion_text":"-Confirmed menopause"}
• {"criterion_text":"-Moderate to severe vasomotor symptoms (VMS)"}

Exclusion criteria

• {"criterion_text":"-Negative urine hCG test"}
• {"criterion_text":"-Previous thromboembolic event"}
• {"criterion_text":"-The use of opioids, anticoagulating treatment or unwilling to pause fish oil/Omega-3 supplements 3 days prior visit 1 and 3"}
• {"criterion_text":"-Current alcohol or drug abuse"}
• {"criterion_text":"-Hypertension treated with more than one drug"}
• {"criterion_text":"-Severe history of allergy, hypersensitivity, or intolerance to drugs"}
• {"criterion_text":"-Moderate to severe liver and kidney disease"}
• {"criterion_text":"-Diagnosed with type 1 or 2 diabetes"}
• {"criterion_text":"-Chronic diseases requiring immunomodulatory treatments such as rheumatoid arthritis, inflammatory bowel disease, and vasculitis etc."}
• {"criterion_text":"-Known uterine fibroids, Endometriosis, Systemic lupus erythematosus (SLE), otosclerosis, migraine or sleep apnea"}
• {"criterion_text":"-Known Epilepsy or previous seizures or convulsive disorder"}
• {"criterion_text":"-Current or previous hormone replacement therapy"}
• {"criterion_text":"-Current or previous cancer diagnosis"}
• {"criterion_text":"-Known BRCA gene mutation"}
• {"criterion_text":"-Current or previous thyroid disease"}
• {"criterion_text":"-Osteoporosis"}
• {"criterion_text":"-Major psychiatric diagnosis including ongoing medication e.g. selective serotonin re-uptake inhibitors (SSRIs)"}
• {"criterion_text":"-Known prolonged QT or other known clinically significant abnormal ECG, including taking medication that can prolong QT interval (eg. sotalol, dronedarone, amiodarone, methadone, and several antipsychotic drugs)"}
• {"criterion_text":"-Previous myocardial infarction or heart failure"}

Primary endpoints

• {"endpoint_text":"-Change in bone remodeling defined by change in bone markers from baseline to week 8","definition_or_measurement_approach":"Change in bone markers from baseline to week 8"}

Secondary endpoints

• {"endpoint_text":"-Change in serum levels of Hypothalamic–Pituitary–Adrenal (HPA) axis, Hypothalamic-Pituitary-Gonadal (HPG) axis, and Hypothalamic–Pituitary–Thyroid (HPT) axis from baseline to week 8","definition_or_measurement_approach":"Change in specified serum hormone levels from baseline to week 8"}
• {"endpoint_text":"-Change in quality of life evaluated with MENQOL-1 from baseline to week 8","definition_or_measurement_approach":"MENQOL-1 score change from baseline to week 8"}
• {"endpoint_text":"-Change in sexual function evaluated with female sexual function index, and female sexual distress scale-revised from baseline to week 8","definition_or_measurement_approach":"Change in FSFI and FSDS-R scores from baseline to week 8"}
• {"endpoint_text":"-Change in depressive symptoms evaluated by MDI and CES-D from baseline to week 8","definition_or_measurement_approach":"Change in MDI and CES-D scores from baseline to week 8"}
• {"endpoint_text":"-Change in anxiety symptoms evaluated by GAD-7 from baseline to week 8","definition_or_measurement_approach":"Change in GAD-7 scores from baseline to week 8"}
• {"endpoint_text":"-Change in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) from baseline to week 8","definition_or_measurement_approach":"Change in PROMIS SD SF 8b score from baseline to week 8"}
• {"endpoint_text":"-Change in thyroid hormones from baseline to week 4 and 8","definition_or_measurement_approach":"Change in thyroid hormone levels at week 4 and week 8 compared with baseline"}
• {"endpoint_text":"-Change in urine minerals (calcium, creatinine, phosphate, magnesium, sodium) from baseline to weeks 4 and 8","definition_or_measurement_approach":"Change in listed urine mineral measurements at weeks 4 and 8 from baseline"}
• {"endpoint_text":"-Change in mineral homeostasis (serum ionized calcium, calcium, albumin, PTH, phosphate, albumin, vitamin D metabolites) from baseline to week 4 and 8","definition_or_measurement_approach":"Change in specified serum mineral/homeostasis markers at weeks 4 and 8 from baseline"}
• {"endpoint_text":"-Change in serum hCG from baseline to week 4 and 8","definition_or_measurement_approach":"Change in serum hCG measured at weeks 4 and 8 vs baseline"}
• {"endpoint_text":"-Change in thyroid hormone conversion (DIO2 activity) in fat cells determined by their conversion of T4 to T3 from baseline to week 8","definition_or_measurement_approach":"Change in DIO2 activity in fat cell assays comparing baseline and week 8"}
• {"endpoint_text":"-Change in adrenal hormones from baseline to week 4 and 8","definition_or_measurement_approach":"Change in adrenal hormone levels at weeks 4 and 8 vs baseline"}
• {"endpoint_text":"-Change in the mean frequency of moderate to severe VMS from Baseline to week 8","definition_or_measurement_approach":"Change in mean frequency of moderate-to-severe vasomotor symptoms from baseline to week 8"}
• {"endpoint_text":"-Change in the mean frequency of moderate to severe VMS from Baseline to week 4","definition_or_measurement_approach":"Change in mean frequency of moderate-to-severe vasomotor symptoms from baseline to week 4"}
• {"endpoint_text":"-Change in the mean severity-score from Baseline to week 8","definition_or_measurement_approach":"Change in mean severity score of VMS from baseline to week 8"}
• {"endpoint_text":"-Change in the mean severity-score from Baseline to week 4","definition_or_measurement_approach":"Change in mean severity score of VMS from baseline to week 4"}
• {"endpoint_text":"-Change in VMS measured using the questionnaire ‘GCS’ from baseline to week 8","definition_or_measurement_approach":"Change in GCS questionnaire results from baseline to week 8"}
• {"endpoint_text":"-Change in serum LH and FSH from baseline to weeks 4 and 8","definition_or_measurement_approach":"Change in LH and FSH levels at weeks 4 and 8 vs baseline"}
• {"endpoint_text":"-Change in serum estradiol and SHGB from baseline to week 4 and 8","definition_or_measurement_approach":"Change in serum estradiol and SHBG at weeks 4 and 8 compared with baseline"}
• {"endpoint_text":"-Change in fasting insulin from baseline to week 8","definition_or_measurement_approach":"Change in fasting insulin measured at week 8 vs baseline"}
• {"endpoint_text":"-Change in HbA1C and HOMA-IR from baseline to week 8","definition_or_measurement_approach":"Change in HbA1C and HOMA-IR from baseline to week 8"}
• {"endpoint_text":"-Change in total cholesterol, cholesterol (total, HDL, LDL), and triglycerides from baseline to week 4 and 8","definition_or_measurement_approach":"Change in lipid panel components at weeks 4 and 8 vs baseline"}
• {"endpoint_text":"-Change in RANKL from baseline to weeks 4 and 8","definition_or_measurement_approach":"Change in serum RANKL at weeks 4 and 8 compared with baseline"}
• {"endpoint_text":"-Change in kidney function (serum creatinine, sodium, potassium, urea) from baseline to week 4 and 8","definition_or_measurement_approach":"Change in listed kidney function tests at weeks 4 and 8 vs baseline"}
• {"endpoint_text":"-Change in hepatic enzymes (ALAT, ASAT, GGT, alkaline phosphatase) from baseline to week 4 and 8","definition_or_measurement_approach":"Change in hepatic enzyme values at weeks 4 and 8 vs baseline"}
• {"endpoint_text":"-Change in QTc using electrocardiogram (ECG) at baseline to week 8","definition_or_measurement_approach":"Change in QTc interval measured by ECG from baseline to week 8"}
• {"endpoint_text":"-Change in weight at baseline to week 8","definition_or_measurement_approach":"Change in body weight measured at week 8 vs baseline"}
• {"endpoint_text":"-Change in RNA expression (RNAseq) in abdominal fat (abdominal fat biopsies) from baseline to week 8 and following in vitro stimulation with hormones and treatments such as LH/hCG","definition_or_measurement_approach":"RNAseq changes in abdominal fat biopsies at week 8 and after in vitro stimulation compared with baseline"}
• {"endpoint_text":"-Change in Cerebral Spinal Fluid (CSF) hormone, mineral or neuropeptide levels between all 4 treatment arms at week 8","definition_or_measurement_approach":"Change in CSF biomarkers at week 8 between treatment arms"}
• {"endpoint_text":"-Change in frequency and type of reported adverse events between baseline and week 4 and 8","definition_or_measurement_approach":"Frequency and type of reported adverse events collected and compared between baseline, week 4 and week 8"}

Methods

• K1_Recruitment arrangements (document present) — target audience: postmenopausal women; country: Denmark
• K2_Recruitment material_SoMe (document present) — social media recruitment materials for outreach
• K2_Recruitment material_Poster (document present) — printed poster materials for recruitment
• K2_Recruitment material_Pamphlet (document present) — pamphlet/information leaflet for potential participants

Denmark

Earliest CTIS Part Ii Submission Date

29-07-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

213

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Hovedstaden (Nordre Fasanvej 57, Frederiksberg)","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}