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COMPASS - COpenhagen MenoPAuSe Study

NCT07254429 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Menopausal Osteoporosis
  • Bone Markers

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

Sponsors & Collaborators

  • Martin Blomberg Jensen

    lead OTHER

Principal Investigators

  • Martin Blomberg Jensen, D.M.Sc. · Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2027-12-31
Completion
2028-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254429 on ClinicalTrials.gov