Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

(22423 NIRVANA) A randomized, parallel-group treatment, Phase 2, double-blind pilot study to investigate the efficacy and safety of elinzanetant compared with placebo for treatment of sleep disturbances associated with menopause

This research study, called NIRVANA, is looking into a new medicine called elinzanetant. It's designed for women who are having trouble sleeping because of menopause. Scientists want to find out if this new medicine can help women get better sleep and how safe it is to use. Some participants will receive elinzanetant, while others will get a placebo, which is a dummy pill with no active medicine. This allows researchers to compare the effects fairly. The study is particularly interested in how long people stay awake after first falling asleep and how much total sleep they get, using special sleep monitoring tests and questionnaires.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bayer Consumer Care AG, Bayer AG

Enrolment target

Start

07 Mar 2024

Sleep disturbances associated with menopause

What is this study about?

Many women going through menopause experience sleep problems, which can be really disruptive to daily life. This study is exploring a potential new treatment called elinzanetant. It's a 'Phase 2' study, which means it's an early-stage trial trying to understand if the treatment works and if it's safe before wider studies are done. The main goal is to see if this new medicine can improve sleep disturbances linked to menopause.

Participants will be placed into groups by chance (randomized). Some will receive the new medicine, elinzanetant, while others will get a placebo, which looks identical but contains no active medicine. This 'double-blind' approach means neither the participants nor their doctors will know who is getting which treatment, ensuring the results are as unbiased as possible. This is a common and important way to test new medicines.

The researchers will be carefully measuring aspects of sleep, such as how long it takes to fall asleep, how often people wake up during the night, and how much total sleep they get. They will use special sleep tests and ask participants to fill out questionnaires about their sleep and general well-being. They will also keep a close eye on any side effects to make sure the treatment is safe.

Key takeaways

This study is testing a new medicine for sleep problems linked to menopause.
It aims to see if the medicine improves sleep and is safe.
Participants will receive either the new medicine or a dummy pill.
Your sleep will be carefully monitored using special tests and questionnaires.
You must be a woman aged 18 or over and experiencing menopausal sleep issues.
You can stop participating at any time if you wish, without affecting your care.

Who may be eligible?

This study is for women who are 18 years old or older and are experiencing sleep problems specifically because of menopause.

It's important to remember that this is a general guide. There will be other specific health requirements or conditions that might mean someone can't join the study. If you're interested, the study team will ask you some detailed questions to see if it’s suitable 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 experiencing sleep problems?
Are these sleep problems related to menopause?

Answer every question to see your result.

What does participation involve?

If you join this study, it would involve taking either the study medicine or a dummy pill for a period of time. You would have a series of appointments at a clinic where doctors and nurses would check your health, ask about your sleep, and explain the next steps. These visits might include detailed sleep tests where special equipment monitors your sleep through the night.

You would also be asked to complete questionnaires about your sleep and how you are feeling generally. Regular blood tests might be needed to check your health and how your body is responding to the treatment. The total duration of your participation, including follow-up checks, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could help improve your sleep problems related to menopause. Even if you receive the placebo, your health and sleep will be carefully monitored. The potential risks involve possible side effects from the study medicine, which will be carefully explained to you. There's also the time commitment involved with clinic visits and assessments. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Germany
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Unverified
Austria
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Unverified
Belgium
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Unverified
Netherlands
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Unverified
Poland
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Unverified
Czechia
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Unverified
Spain

Common questions

What is menopause?

Menopause is a natural stage in a woman's life when her periods stop, usually between the ages of 45 and 55. It marks the end of her reproductive years.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the actual medicine but doesn't contain any active ingredients. It helps researchers compare the real effects of the medicine.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make the study fair and unbiased.

What is a 'Phase 2' study?

A Phase 2 study is an early stage of clinical research. It mainly aims to see if a new medicine works for a specific condition and to find out more about its safety.

Will I get paid for taking part?

Compensation for participation may vary by study site. This is a good question to ask the study team when you contact them.