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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 40 to 65 Women only

COMPASS: Copenhagen Menopause Project testing hormone and LH‑blocking treatments

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

Run by Copenhagen University Hospital at Herlev · NCT07254429 · Data updated 2026-11-12

This 8-week randomized study will test whether blocking LH, or giving estrogen or testosterone, helps bone health and menopausal symptoms in women aged 40–65 with frequent hot flashes.

Quick facts

PhasePhase 2
Study typeInterventional
Ages40 Years to 65 Years
SexWomen only
Enrollment192 (estimated)
SponsorCopenhagen University Hospital at Herlev
Academic / other
Locations1 site (Herlev)
StatusRecruiting
StartedOctober 2, 2025
Main results expectedDecember 2027
Study endsMay 2028
Registry record updatedMarch 2, 2026
Trial IDNCT07254429 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged >40 to ≤65 with confirmed menopause, BMI 18–35, at least 14 moderate-to-severe vasomotor symptoms per week, and willing/able to pause hormone therapies as required are the ideal candidates.

Probably not a fit

Women with diagnosed osteoporosis, current or recent hormone replacement therapy, active or prior cancer (other than basal cell carcinoma), known BRCA mutation, untreated hyperthyroidism, or major psychiatric disorders were excluded and are unlikely to benefit from or join this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, single-blinded Phase 2 randomized trial at Copenhagen University Hospital Herlev compares four parallel arms over 8 weeks: a GnRH analog (triptorelin), placebo, estradiol, and testosterone, with endpoints focused on bone markers and symptom changes. Eligible participants are women aged 40–65 with confirmed menopause and at least 14 moderate-to-severe vasomotor symptoms per week. The protocol excludes women with established osteoporosis, current or recent hormone therapy, prior cancer (except basal cell carcinoma), BRCA mutations, uncontrolled hyperthyroidism, or major psychiatric illness. Investigators will collect biochemical bone markers and clinical symptom data to compare short-term effects across the treatment arms.

Why it matters

Potential benefit: If successful, this approach could offer a non‑estrogen option to protect bone and improve metabolic health and menopausal symptoms while avoiding some estrogen-related risks.

How similar studies have gone: Previous research links high LH to bone loss and metabolic problems and drugs like fezolinetant relieve hot flashes, but using LH blockade specifically to protect bone is a relatively novel approach with limited prior clinical trial evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Women \>40 years and ≤65 at screening visit
* A body mass index between 18-35
* Confirmed menopause

  * Method 1
  * Spontaneous amenorrhea for ≥12 consecutive months
  * Negative urine hCG test
  * Method 2
  * Spontaneous amenorrhea for ≥6 months
  * FSH \>30 mIU/L
  * Negative urine hCG test
* Moderate to severe vasomotor symptoms (VMS)

  * Within the 7 days prior to randomization, participants must report ≥ 14 moderate to severe VMS per week

Exclusion Criteria:

* Current or previous hormone replacement therapy (HRT)

  * Vaginal estradiol/vaginal inserts (e.g. Vagifem®) can be used, but will have to be pause 2 weeks prior to randomization and throughout the study period
  * Menopausal Hormone Therapy (MHT) can be used by participants, but must be paused 6 weeks prior to inclusion.
* Current or previous cancer diagnosis

  * Except for basal cell carcinoma
* Known BRCA gene mutation
* Current hyperthyroid disease
* Osteoporosis
* Major psychiatric diagnosis including ongoing medication e.g. selective serotonin re-uptake inhibitors (SSRIs)
* Known prolonged QT or other known clinically significant abnormal ECG, including taking medication that can prolong QT interval (e.g. sotalol, dronedarone, amiodarone, methadone, and several antipsychotic drugs)
* Previous myocardial infarction or heart failure
* Previous thromboembolic event
* The use of opioids, anticoagulating treatment or unwilling to pause fish oil/Omega-3 supplements 3 days prior visit 1 and 3
* Current alcohol or drug abuse
* Hypertension treated with more than two drugs
* Severe history of allergy, hypersensitivity, or intolerance to drugs
* Moderate to severe liver and kidney disease (eGFR \<60 mL/min)
* Diagnosed with type 1 or 2 diabetes
* Chronic diseases requiring immunomodulatory treatments such as rheumatoid arthritis, inflammatory bowel disease, and vasculitis etc.
* Known uterine fibroids, Endometriosis, Systemic lupus erythematosus (SLE), otosclerosis, severe migraine or sleep apnea
* Known Epilepsy or previous seizures or convulsive disorder

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.