AuthorisedTherapeutic confirmatory (Phase III)Interventional

Safety of oral micronized progesterone versus norethisterone acetate in continuous combination with oral estrogen as menopausal hormone therapy – a double-blind randomized study- PROBES study (Progesterone Breast Endometrial Safety study)

This study, called PROBES, is looking into the safety of two different hormone treatments for women going through menopause. These treatments aim to help with common symptoms like hot flushes and mood changes. Researchers want to compare Utrogestan (a form of progesterone) with norethisterone acetate, both given alongside oestrogen. The main goal is to see how these two treatments affect breast density, which can sometimes be a concern with hormone therapy. They will also check the womb lining for any changes and look at overall well-being, mood, and other important health markers. This is a large study to confirm which treatment might be a better choice for long-term use.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Karolinska University Hospital

Enrolment target

520

Start

17 Jan 2025

Climacteric symptoms

What is this study about?

When women go through menopause, their bodies produce less of certain hormones, which can lead to uncomfortable symptoms like hot flushes, night sweats, and mood changes. Hormone replacement therapy (HRT) can help relieve these symptoms. HRT usually involves taking oestrogen, and often another hormone called progestogen, to protect the womb lining.

This study, called PROBES, is comparing two types of progestogen – Utrogestan and norethisterone acetate – when taken with oestrogen. Both are used in HRT, but researchers want to understand more about their long-term safety, particularly how they affect breast health and the womb lining. The study will help doctors learn which option might be better for women needing HRT.

By carefully looking at changes in breast density and the womb lining, alongside other health markers, the study aims to provide important information. This could lead to clearer guidance on which type of HRT is safest and most effective for women. It's about making sure women have the best and safest choices for managing their menopausal symptoms.

Key takeaways

Compares two HRT types (Utrogestan vs. norethisterone acetate) for safety.
Focuses on breast density and womb health in menopausal women.
Aims to find the safest HRT option for long-term use.
Involves regular health checks, scans, and questionnaires.
Participation contributes to important medical research.
You have the right to leave the study at any time.

Who may be eligible?

This study is open to women who are experiencing menopausal symptoms and are considering or currently using hormone replacement therapy (HRT). You would need to be 18 years old or older to take part.

They are particularly looking for women who are suitable for continuous combined HRT, which means taking both oestrogen and a progestogen every day. This is typically for women who have gone through menopause and no longer have periods.

Please note, there will be other specific health requirements or conditions that might mean you can't join the study. These will be discussed with you by the study team to ensure your safety.

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 aged 18 or over?
Are you experiencing menopausal symptoms?
Are you interested in or currently using hormone replacement therapy (HRT)?
Are you suitable for continuous combined HRT (oestrogen and progestogen daily)?
Are you willing to attend regular clinic visits?
Are you able to provide informed consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of two types of hormone treatment: either Utrogestan or norethisterone acetate, both given with oestrogen tablets. Neither you nor your study doctor would know which one you are receiving – this is called a 'double-blind' study.

Your participation would involve several visits to the clinic over a period of time. During these visits, the study team would: conduct physical examinations, take blood samples to check hormone levels and other health markers, ask you to complete questionnaires about your mood and quality of life, and perform ultrasound scans of your womb. You would also have mammogram scans to check your breast density. You would also keep a diary to track any bleeding patterns. The total duration of your participation would be explained fully by the study team.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving regular medical check-ups and close monitoring of your health. You would also contribute to valuable research that could improve future treatments for other women experiencing menopause. However, there are potential risks, including side effects from the medication, which would be fully explained before you agree to participate. There's also the chance the treatment you receive might not be the most effective for you. You have the right 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
Sweden

Common questions

What are 'climacteric symptoms'?

These are simply another name for menopausal symptoms, such as hot flushes, night sweats, mood changes, and difficulty sleeping, which happen as a woman approaches and goes through menopause.

What is the difference between Utrogestan and norethisterone acetate?

Both are types of progestogen, hormones used in HRT. This study is aiming to find out if one is safer or has different effects on the body, especially on breast density and the womb lining, when taken with oestrogen.

Why is breast density important?

Changes in breast density can sometimes be linked to certain hormone treatments. The study wants to check if either treatment affects breast density differently, as this is a key part of understanding the overall safety profile.

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which of the two active treatments you are receiving. This helps make the study results more reliable.

What is 'Phase III' of a clinical trial?

Phase III is a large and important stage in testing a new treatment. It's designed to confirm how effective and safe a treatment is, comparing it to existing treatments or a placebo, in many more people before it can be widely approved for use.