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.
• 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