NCT07254429RecruitingPhase 2
COMPASS - COpenhagen MenoPAuSe Study
Copenhagen Menopause Study (COMPASS): A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
During menopause, estrogen levels drop while the level of another hormone - LH (luteinizing hormone) substantially increases. This hormonal shift is linked to bone Loss and other complications. Estrogen therapy can help, but some women avoid it due to the increased risk of blood clots and cancer. This project will investigate whether blocking LH could offer a safe alternative to alleviate symptoms and complications of menopause since it is known from previous research that high LH levels contribute to both bone deterioration and metabolic issues. The goal is to explore new treatment options that can improve health and quality of life for women both during and after menopause. This randomized clinical trial is a single center, sponsor-investigator-initiated single-blinded 8 weeks clinical trial with four parallel groups comparing the effect of an gonadotropin releasing hormone(GnRH)-analog with placebo, and with two additional arms given estrogen or testosterone on change on bone health in postmenopausal women with moderate-to-severe symptoms.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- First submitted
- 30 Sept 2025
- Start date
- 2 Oct 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Martin Blomberg Jensen
- Diseases
- Osteoporosis
- NCT number
- NCT07254429
- EU CT number
- 2025-522558-37-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 192
- From 2 Oct 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous hormone replacement therapy (HRT)
- Vaginal estradiol/vaginal inserts (e.g. Vagifem®) can be used, but will have to be pause 2 weeks prior to randomization and throughout the study period
- Menopausal Hormone Therapy (MHT) can be used by participants, but must be paused 6 weeks prior to inclusion.
- Previous myocardial infarction or heart failure
- Previous thromboembolic event
- The use of opioids, anticoagulating treatment or unwilling to pause fish oil/Omega-3 supplements 3 days prior visit 1 and 3
- Current alcohol or drug abuse
- Hypertension treated with more than two drugs
- Known Epilepsy or previous seizures or convulsive disorder
Other illness
- Current or previous cancer diagnosis
- Except for basal cell carcinoma
- Current hyperthyroid disease
- Major psychiatric diagnosis including ongoing medication e.g. selective serotonin re-uptake inhibitors (SSRIs)
- Severe history of allergy, hypersensitivity, or intolerance to drugs
- Diagnosed with type 1 or 2 diabetes
- Chronic diseases requiring immunomodulatory treatments such as rheumatoid arthritis, inflammatory bowel disease, and vasculitis etc.
Lab values
- Known prolonged QT or other known clinically significant abnormal ECG, including taking medication that can prolong QT interval (e.g. sotalol, dronedarone, amiodarone, methadone, and several antipsychotic drugs)
- Moderate to severe liver and kidney disease (eGFR \<60 mL/min)
Other
- Known BRCA gene mutation
- Osteoporosis
- Known uterine fibroids, Endometriosis, Systemic lupus erythematosus (SLE), otosclerosis, severe migraine or sleep apnea
Who the study is looking for
- Women \>40 years and ≤65 at screening visit
- A body mass index between 18-35
- Confirmed menopause
- Method 1
- Spontaneous amenorrhea for ≥12 consecutive months
- Negative urine hCG test
- Method 2
- Spontaneous amenorrhea for ≥6 months
- FSH \>30 mIU/L
- Negative urine hCG test
- Moderate to severe vasomotor symptoms (VMS)
- Within the 7 days prior to randomization, participants must report ≥ 14 moderate to severe VMS per week
Age in the registry: 40 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev. Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.