Could blocking a hormone be the key to menopausal bone health?
NCT ID NCT07254429
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether blocking a hormone called LH can improve bone health in menopausal women. 192 women with moderate-to-severe hot flashes will receive either a GnRH analog, estrogen, testosterone, or a placebo for 8 weeks. The goal is to find a safer alternative to estrogen therapy for preventing bone loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Triptorelin (GnRH analog), Estradiol, Testosterone
- What this could lead to
- If successful, this could point toward a new hormone-blocking treatment for menopausal bone loss that avoids the risks of estrogen therapy.
- What could go wrong
- This is a small, early-phase trial with only 192 participants over 8 weeks. The results may not apply to all women, and the GnRH analog may cause side effects like hot flashes or mood changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev.
RECRUITINGHerlev, Denmark
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