COMPASS - COpenhagen MenoPAuSe Study

What Was Tested

The trial (phase 2) is built around Triptorelin for osteoporosis and bone density.

This hormonal shift is linked to bone Loss and other complications.

It had four arms (groups): GnRH analog (active comparator), Placebo (placebo comparator), Transdermal Estrogen (active comparator) and Transdermal testosterone (active comparator).

Saline intramuscular injection once + Daily placebo gel.

The registry classes the interventions as drug.

More on the Plan

The hormonal changes occurring in perimenopause and menopause exert multiple effects on several organs and the accompanied symptoms can be very distressing and impair quality of life.

Along with obesity comes a wide variety of health issues such as type 2 diabetes, metabolic syndrome, and atherosclerosis, which can lead to cardiovascular disease.

Postmenopausal symptoms and complications take a large toll on both the physical and mental well-being of women and are a huge cost to society.

The newly approved Veoza® (Fezolinetant) is also approved and on the marked, but only targets VMS and not menopausal complications, but can be a treatment option, if the woman can or will not have MHT.

Who Took Part

Enrollment: 192 planned participants were the target.

It was open to women only aged from 40 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women \>40 years and ≤65 at screening visit. A body mass index between 18-35. Spontaneous amenorrhea for ≥12 consecutive months. Negative urine hCG test. Spontaneous amenorrhea for ≥6 months.

The full record lists 12 inclusion and 21 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The osteoporosis and bone density participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

The Triptorelin group and the comparison group ran side by side rather than switching.

Only one side, usually the osteoporosis and bone density participants, was kept unaware of whether Triptorelin was given.

Those kept unaware of assignments: participant.

It started in 2025-10-02 with completion listed for 2027-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in bone remodeling from baseline to week 8 (time frame: From baseline to week 8). Change in bone remodeling from baseline to week 8 (time frame: From baseline to week 8). Change in bone remodeling from baseline to week 8 (time frame: From baseline to week 8).

It also tracked 38 secondary outcomes, for example Change in serum levels of Hypothalamic-Pituitary-Adrenal (HPA) axis from baseline to week 8, Change in serum levels of Hypothalamic-Pituitary-Gonadal (HPG) axis from baseline to week 8, Change in serum levels of Hypothalamic-Pituitary-Thyroid (HPT) axis from baseline to week 8, Change in quality of life evaluated with MENQOL-1 from baseline to week 8, Change in sexual function evaluated with female sexual function index from baseline to week 8 and Change in sexual function evaluated with female sexual distress scale-revised from baseline to week 8.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 192 people with osteoporosis and bone density.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, Osteoporosis and bone density research.