COMPASS - COpenhagen MenoPAuSe Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorMartin Blomberg Jensen

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

192 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Martin Blomberg Jensen

Lead sponsor

Copenhagen University Hospital at Herlev

Sponsor institution