RecruitingPhase 2NCT07254429

COMPASS - COpenhagen MenoPAuSe Study

Copenhagen Menopause Study (COMPASS): A Randomized Clinical Trial


Sponsor

Martin Blomberg Jensen

Enrollment

192 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Estradiol (E2), a drug called Placebo gel, and others for people with bone markers and menopausal osteoporosis. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 40 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTriptorelin 11.25 mg

Pamorelin 11.25 mg intramuscular injection once

DRUGSodium Chloride 0.9%

Saline intramuscular injection once

DRUGEstradiol (E2)

Estreva gel 1.5 mg daily

DRUGTestosterone

Tostran gel 10 mg every other day

DRUGPlacebo gel

Placebo gel every day or every other day


Locations(1)

Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev.

Herlev, Denmark

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NCT07254429