AuthorisedTherapeutic exploratory (Phase II)Interventional

COMPASS - COpenhagen MenoPAuSe Study

The COMPASS study aims to explore different approaches for women experiencing menopause. Researchers are testing several gels, including a placebo (a dummy gel without active ingredients) and those containing hormones, to see how they impact various aspects of health. The main goal is to understand how these treatments affect bone changes. They will also look at how hormones change, and how symptoms like mood, sleep, quality of life, and sexual function are affected. This Phase II study helps to explore the potential effects of these treatments in a small group of volunteers over an 8-week period. It helps prepare for larger studies if the early results are promising.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Hovedstaden

Enrolment target

200

Start

20 Aug 2025

Menopause

What is this study about?

The COMPASS study, which stands for COpenhagen MenoPAuSe Study, is looking into new ways to help women manage their menopause symptoms. Menopause is a natural stage in a woman's life when her periods stop, usually between the ages of 45 and 55. It can bring about various changes and symptoms, such as hot flashes, night sweats, mood swings, and changes in bone health.

In this study, researchers are testing several different gels. Some of these gels contain hormones, while others are a 'placebo,' which is a dummy gel with no active medicine. The main thing they want to find out is how these gels affect a woman's bones. They’ll do this by looking at special signs in the body that tell them about bone changes. This part of the study lasts for 8 weeks.

Beyond bone health, the study will also investigate many other important aspects of health during menopause. This includes understanding how different hormones in the body (like those that control stress and energy) are affected, and how a woman's overall well-being changes. They will check things like mood, anxiety levels, sleep patterns, quality of life, and sexual function. This helps paint a complete picture of how the treatments might help women feel better day-to-day.

Key takeaways

The COMPASS study investigates treatments for menopause symptoms.
It tests various gels, including a placebo, over an 8-week period.
The study focuses on bone health, hormones, mood, sleep, and overall well-being.
It is a Phase II study, exploring early effects in a smaller group.
Participation involves using gels, clinic visits, and completing questionnaires.

Who may be eligible?

To be considered for the COMPASS study, you must be a woman aged 18 years or older. There is no upper age limit, meaning women of all adult ages who meet other criteria can potentially join.

The study is specifically looking for women who are experiencing menopause. The exact details of what 'experiencing menopause' means for this study would be explained by the study team, but it generally refers to a time when your periods have stopped naturally for a certain amount of time, or if you've had surgery that caused menopause.

It's important to remember that even if you meet these general age and sex requirements, there might be other specific health conditions or medications that would prevent you from taking part. The study team will discuss all of these details with you during a screening process to make sure the study is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Are you currently experiencing menopause?
Are you able to attend clinic visits over an 8-week period?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the COMPASS study, you would primarily be using one of the assigned gels (which could be the active treatment or a placebo) for 8 weeks. Throughout this time, you would have several visits to the clinic.

During these visits, the study team would take blood samples to check your bone health, hormone levels, and other bodily functions. You would also be asked to provide urine samples. You'd fill out questionnaires designed to understand how you're feeling, including questions about your quality of life, sexual function, mood, anxiety, and sleep patterns. These assessments help the researchers understand how the treatments are affecting you. The total duration of active participation in the study, including all treatments and assessments, would be 8 weeks.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as contributing to scientific understanding that might help other women going through menopause in the future. You would also receive close medical attention and monitoring throughout the 8-week period. However, there are potential risks, which will be fully explained by the study team. These could include side effects from the gels, discomfort from blood tests, or the possibility that the treatment might not improve your symptoms if you receive the placebo or if the active treatment doesn't work for you. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is menopause?

Menopause is when a woman's periods stop, usually in her late 40s or 50s. It marks the end of her reproductive years.

What is a placebo gel?

A placebo gel looks exactly like the real treatment but doesn't contain any active medicine. It helps researchers see if the real medicine has an effect or if improvement is due to other factors.

What does 'bone remodeling' mean?

'Bone remodeling' is the natural process where old bone tissue is removed and new bone tissue is formed. This study looks at how treatments affect this process.

How long will I be in the study?

Your active participation, including using the gels and having tests, will last for 8 weeks.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.