What this trial studies
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.
Conditions in scope
- Menopausal Osteoporosis
- Bone Markers
Interventions
- Triptorelin 11.25 mg (Drug) — Pamorelin 11.25 mg intramuscular injection once
- Sodium Chloride 0.9% (Drug) — Saline intramuscular injection once
- Estradiol (E2) (Drug) — Estreva gel 1.5 mg daily
- Testosterone (Drug) — Tostran gel 10 mg every other day
- Placebo gel (Drug) — Placebo gel every day or every other day
Who can join
Women only · Ages 40 Years to 65 Years
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
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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Herlev | Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev. | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: PHASE2
- Start date: 2025-10-02
- Primary completion: 2027-12
- Last update posted: 2026-03-02
- First posted: 2025-11-28
Sponsor & contact
Lead sponsor: Martin Blomberg Jensen (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Change in bone remodeling from baseline to week 8. (From baseline to week 8)
Change in bone remodeling defined by change in bone marker (ΔCTX) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1. GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2.… - Change in bone remodeling from baseline to week 8. (From baseline to week 8)
Change in bone remodeling defined by change in bone marker (ΔP1NP) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2)… - Change in bone remodeling from baseline to week 8 (From baseline to week 8)
Change in bone remodeling defined by change in bone marker-ratios (ΔCTX/ΔP1NP, and ΔBBI) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following…
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07254429 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.