About this trial
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.
Eligibility criteria
Qualifiers
Women >40 years and ≤65 at screening visit
A body mass index between 18-35
Confirmed menopause
Method 1
Disqualifiers
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
Trial design
Treatments tested in this trial
- Triptorelin 11.25 mg
- Sodium Chloride 0.9%
- Estradiol (E2)
- Testosterone
- Placebo gel
Treatment groups
Sponsors and collaborators
Martin Blomberg Jensen
Lead sponsor
Copenhagen University Hospital at Herlev
Sponsor institution