What is this study trying to find out about menopausal osteoporosis?

This study is exploring whether blocking luteinizing hormone (LH) can improve bone health and reduce menopausal symptoms in women after menopause. Researchers want to find new treatment options that might be safer alternatives to estrogen therapy. The study is led by Martin Blomberg Jensen and compares different hormone treatments in postmenopausal women.

Who may be eligible for this menopausal osteoporosis clinical trial?

Women aged 40 to 65 years with confirmed menopause and moderate to severe hot flashes may be eligible. Participants must have a body mass index between 18 and 35 and not currently use hormone replacement therapy. Only females can join. Please review eligibility criteria for more details.

Is there any cost to participate in this menopausal osteoporosis clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel expenses vary and may not be covered. Participants should be prepared for potential out-of-pocket costs related to travel or lodging.

Actively Recruiting

Phase 2

Age: 40Years - 65Years

FEMALE

ID07254429

Copenhagen Menopause Study COMPASS A Randomized Clinical Trial on Hormone Treatments for Bone Health and Menopausal Symptoms

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

192

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

This research investigates whether blocking luteinizing hormone LH can provide a safe alternative treatment for bone loss and menopausal symptoms in postmenopausal women. The study focuses on women who experience moderate-to-severe vasomotor symptoms during menopause, a time when estrogen levels drop and LH rises sharply. The trial aims to explore new options beyond traditional estrogen therapy, which some women avoid due to risks like blood clots and cancer. The trial is a randomized, single-blinded clinical study with four parallel groups lasting 8 weeks. Participants receive one of four treatments a single intramuscular injection of the GnRH analog pamorelin plus daily placebo gel, a placebo injection plus daily placebo gel, a placebo injection plus daily estradiol gel, or a placebo injection plus testosterone gel every other day with placebo gel on alternate days. These treatments are compared to evaluate their effects on bone health and menopausal symptoms. Participants will undergo regular assessments including blood and urine tests to measure bone remodeling markers, hormone levels, and metabolic factors from baseline through week 8. The study also evaluates changes in quality of life, sexual function, mood symptoms, sleep disturbances, and physical strength. Safety monitoring and reporting of side effects will occur throughout, with participants able to leave the trial at any time. The total study participation lasts 8 weeks with detailed follow-up for the primary and secondary outcomes.

CONDITIONS

Brief Title

COMPASS - COpenhagen MenoPAuSe Study

Who Can Participate

Age: 40Years - 65Years

FEMALE

Eligibility Criteria

You may qualify if you...

Women aged between 40 and 65 years at screening visit
Body mass index between 18 and 35
Confirmed menopause by either 12 months of no periods with negative urine hCG or 6 months of no periods with FSH >30 mIU/L and negative urine hCG
Moderate to severe vasomotor symptoms with at least 14 episodes per week within 7 days before randomization

You will not qualify if you...

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

Research Team

Martin Blomberg Jensen, D.M.Sc

Nadia Poulsen, MD

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