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New treatment option for Menopausal Osteoporosis
Official title COMPASS - COpenhagen MenoPAuSe Study
ClinicalTrials.gov ID: NCT07254429
What this study is testing
What is Triptorelin 11.25 mg?
Triptorelin 11.25 mg is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for menopausal osteoporosis.
Also referred to as Pamorelin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.