COMPASS - COpenhagen MenoPAuSe Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Phenomena and Processes [G] - Physiological processes [G07]

Decision date (initial)

2025-08-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

A randomized single-blinded 8 weeks clinical trial with four parallel groups comparing the effect of an gonadotropin releasing hormone(GnRH)-analog, transdermal estrogen or transdermal testosterone to placebo on change in bone markers in postmenopausal women.

Secondary objectives 10

1. Symptoms
2. Other complications
3. Quality of life
4. Urinary mineral excretion
5. Adrenal hormones
6. Thyroid hormones
7. Spinal fluid composition
8. RNA expression in fat tissue
9. Sexual function
10. Vaso-motor symtoms

Conditions and MedDRA coding

Menopause

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Women >40 years and ≤65 at screening visit
2. A body mass index between 18-35
3. Confirmed menopause
4. Moderate to severe vasomotor symptoms (VMS)

Exclusion criteria 19

1. Negative urine hCG test
2. Current or previous hormone replacement therapy
3. Current or previous cancer diagnosis
4. Known BRCA gene mutation
5. Current or previous thyroid disease
6. Osteoporosis
7. Major psychiatric diagnosis including ongoing medication e.g. selective serotonin re-uptake inhibitors (SSRIs)
8. 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)
9. Previous myocardial infarction or heart failure
10. Previous thromboembolic event
11. The use of opioids, anticoagulating treatment or unwilling to pause fish oil/Omega-3 supplements 3 days prior visit 1 and 3
12. Current alcohol or drug abuse
13. Hypertension treated with more than one drug
14. Severe history of allergy, hypersensitivity, or intolerance to drugs
15. Moderate to severe liver and kidney disease
16. Diagnosed with type 1 or 2 diabetes
17. Chronic diseases requiring immunomodulatory treatments such as rheumatoid arthritis, inflammatory bowel disease, and vasculitis etc.
18. Known uterine fibroids, Endometriosis, Systemic lupus erythematosus (SLE), otosclerosis, migraine or sleep apnea
19. Known Epilepsy or previous seizures or convulsive disorder

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in bone remodeling defined by change in bone markers from baseline to week 8

Secondary endpoints 30

1. 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
2. Change in quality of life evaluated with MENQOL-1 from baseline to week 8
3. Change in sexual function evaluated with female sexual function index, and female sexual distress scale-revised from baseline to week 8
4. Change in depressive symptoms evaluated by MDI and CES-D from baseline to week 8
5. Change in anxiety symptoms evaluated by GAD-7 from baseline to week 8
6. Change in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) from baseline to week 8
7. Change in thyroid hormones from baseline to week 4 and 8
8. Change in urine minerals (calcium, creatinine, phosphate, magnesium, sodium) from baseline to weeks 4 and 8
9. Change in mineral homeostasis (serum ionized calcium, calcium, albumin, PTH, phosphate, albumin, vitamin D metabolites) from baseline to week 4 and 8
10. Change in serum hCG from baseline to week 4 and 8
11. Change in thyroid hormone conversion (DIO2 activity) in fat cells determined by their conversion of T4 to T3 from baseline to week 8
12. Change in adrenal hormones from baseline to week 4 and 8
13. Change in the mean frequency of moderate to severe VMS from Baseline to week 8
14. Change in the mean frequency of moderate to severe VMS from Baseline to week 4
15. Change in the mean severity-score from Baseline to week 8
16. Change in the mean severity-score from Baseline to week 4
17. Change in VMS measured using the questionnaire ‘GCS’ from baseline to week 8
18. Change in serum LH and FSH from baseline to weeks 4 and 8
19. Change in serum estradiol and SHGB from baseline to week 4 and 8
20. Change in fasting insulin from baseline to week 8
21. Change in HbA1C and HOMA-IR from baseline to week 8
22. Change in total cholesterol, cholesterol (total, HDL, LDL), and triglycerides from baseline to week 4 and 8
23. Change in RANKL from baseline to weeks 4 and 8
24. Change in kidney function (serum creatinine, sodium, potassium, urea) from baseline to week 4 and 8
25. Change in hepatic enzymes (ALAT, ASAT, GGT, alkaline phosphatase) from baseline to week 4 and 8
26. Change in QTc using electrocardiogram (ECG) at baseline to week 8
27. Change in weight at baseline to week 8
28. 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
29. Change in Cerebral Spinal Fluid (CSF) hormone, mineral or neuropeptide levels between all 4 treatment arms at week 8
30. Change in frequency and type of reported adverse events between baseline and week 4 and 8

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Borgmester Ib Juuls Vej 1

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Region Hovedstaden

Contact name

Nadia Nicholine Poulsen

Public contact point

Organisation

Region Hovedstaden

Contact name

Nadia Nicholine Poulsen

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications