Actively Recruiting

Phase 2
Age: 40Years - 65Years
FEMALE
NCT07254429

COMPASS - COpenhagen MenoPAuSe Study

Led by Martin Blomberg Jensen · Updated on 2026-03-02

192

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

COMPASS - COpenhagen MenoPAuSe Study

Who Can Participate

Age: 40Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged over 40 and up to 65 years at screening
  • Body mass index between 18 and 35
  • Confirmed menopause by either 12 consecutive months without menstruation and negative urine hCG test, or 6 months without menstruation with FSH >30 mIU/L and negative urine hCG test
  • Moderate to severe vasomotor symptoms with at least 14 episodes per week in the 7 days before randomization
Not Eligible

You will not qualify if you...

  • Current or previous hormone replacement therapy, except vaginal estradiol paused 2 weeks before randomization and throughout the study, and menopausal hormone therapy paused 6 weeks prior
  • Current or previous cancer diagnosis except basal cell carcinoma
  • Known BRCA gene mutation
  • Current hyperthyroid disease
  • Osteoporosis
  • Major psychiatric diagnosis with ongoing medication such as SSRIs
  • Known prolonged QT or other significant abnormal ECG, including medications that prolong QT interval
  • Previous myocardial infarction or heart failure
  • Previous thromboembolic event
  • Use of opioids, anticoagulants, or unwillingness to pause fish oil/Omega-3 supplements 3 days before visits 1 and 3
  • Current alcohol or drug abuse
  • Hypertension treated with more than two drugs
  • Severe allergy, hypersensitivity, or drug intolerance
  • Moderate to severe liver or kidney disease (eGFR <60 mL/min)
  • Diagnosed type 1 or 2 diabetes
  • Chronic diseases requiring immunomodulatory treatments such as rheumatoid arthritis, inflammatory bowel disease, vasculitis
  • Known uterine fibroids, endometriosis, systemic lupus erythematosus, otosclerosis, severe migraine, or sleep apnea
  • Known epilepsy, previous seizures, or convulsive disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Herlev, Denmark

Actively Recruiting

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Research Team

M

Martin Blomberg Jensen, D.M.Sc

CONTACT

N

Nadia Poulsen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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