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RECRUITING
NCT07254429
PHASE2

COMPASS - COpenhagen MenoPAuSe Study

Sponsor: Martin Blomberg Jensen

View on ClinicalTrials.gov

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.

Official title: Copenhagen Menopause Study (COMPASS): A Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2025-10-02

Completion Date

2028-05

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DRUG

Triptorelin 11.25 mg

Pamorelin 11.25 mg intramuscular injection once

DRUG

Sodium Chloride 0.9%

Saline intramuscular injection once

DRUG

Estradiol (E2)

Estreva gel 1.5 mg daily

DRUG

Testosterone

Tostran gel 10 mg every other day

DRUG

Placebo 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