Hormone-Based Treatments and Bone Health in Women After Menopause
Compares hormone treatments for bone health in postmenopausal women with troublesome symptoms.
Plain-language title generated from the registry record
Registry title: COMPASS - COpenhagen MenoPAuSe Study
Key facts
- Where
- Herlev, DenmarkSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 65 years old?
Source: NCT07254429, who can take part
Where in Denmark
- Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev.Herlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Martin Blomberg Jensen
- Trial code
- NCT07254429EU 2025-522558-37-00
- Record updated
- 2 March 2026
- Original description
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.Read full original descriptionShow less
Copenhagen Menopause Study (COMPASS): A Randomized Clinical Trial
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.
Inclusion: 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.
Exclusion: 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; 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; 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); Known BRCA gene mutation; Osteoporosis; Known uterine fibroids, Endometriosis, Systemic lupus erythematosus (SLE), otosclerosis, severe migraine or sleep apnea.