Study on Elinzanetant for Treating Sleep Disturbances in Menopausal Women

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What is this study about?

This clinical trial is focused on studying sleep disturbances associated with menopause. The treatment being tested is a medication called elinzanetant, which is being compared to a placebo. The purpose of the study is to learn about how elinzanetant works and how safe it is for women experiencing sleep problems during menopause.

Participants in the study will be randomly assigned to receive either elinzanetant or a placebo. The study will last for several weeks, during which participants will take the medication in the form of a soft capsule. Throughout the study, participants will be monitored to assess any changes in their sleep patterns and overall well-being.

The study aims to explore the effectiveness of elinzanetant in improving sleep quality for women who are in the post-menopausal period. By the end of the study, researchers hope to gather valuable information on whether elinzanetant can help alleviate sleep disturbances associated with menopause.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, menopausal status, and sleep disturbance history.

Participants must be females aged 40 to 65 years and in the post-menopausal period.

2 initial assessment

An initial assessment is conducted to establish baseline sleep patterns using a method called PSG (polysomnography), which records sleep activity.

Participants must have a WASO (wake after sleep onset) of 30 minutes or more.

3 medication administration

Participants are randomly assigned to receive either elinzanetant or a placebo in the form of a soft capsule.

The medication is taken orally.

4 treatment period

The treatment period lasts for 12 weeks.

Participants continue taking the assigned medication throughout this period.

5 follow-up assessments

Follow-up assessments are conducted at Week 4 and Week 12 to measure changes in sleep patterns using PSG.

Additional assessments include changes in sleep efficiency (SE) and scores from sleep-related questionnaires.

6 monitoring and safety checks

Throughout the study, participants are monitored for any side effects or abnormal laboratory results.

Safety is a priority, and any treatment-emergent adverse events (TEAEs) are recorded.

7 completion of study

The study is estimated to end by January 7, 2025.

Participants complete the study after the final assessment at Week 12.

Who Can Join the Study?

Females aged 40 to 65 years can participate.
Participants must be in the post-menopausal period. This means they should have certain hormone levels: serum FSH (a hormone related to reproduction) levels greater than 40 mIU/mL and serum estradiol (a form of estrogen) concentration less than 30 pg/mL. Additionally, if they have had a hysterectomy (surgical removal of the uterus), it should have been done at least 6 weeks before joining the study.
Participants should have a history of sleep problems related to menopause, such as waking up at night or having poor quality sleep.
Participants should have a WASO (Wake After Sleep Onset) of 30 minutes or more. This means that, on average, they are awake for at least 30 minutes after initially falling asleep, based on two sleep tests, with neither night being less than 20 minutes.

Who Cannot Join the Study?

Men who wish to participate, as the study is only for women.
Women who are not experiencing sleep disturbances associated with menopause.
Individuals who do not fall within the specified age range for the study.
Individuals who are part of a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario Araba	Vitoria	Spain
University Hospital Olomouc	Olomouc	Czechia
Anima	Alken	Belgium
Centro Medico Teknon-Grupo Quironsalud	Barcelona	Spain
FutureMeds GmbH	Berlin	Germany
Klinische Forschung Hamburg GmbH	Hamburg	Germany
Anima	Diepenbeek	Belgium
EMC Instytut Medyczny S.A.	Wroclaw	Poland
Siteworks GmbH	Hanover	Germany
Advanced Sleep Research GmbH	Berlin	Germany
Instytut Psychiatrii I Neurologii	Warsaw	Poland
SGS Belgium	Edegem	Belgium
CHU Saint Pierre	Brussels	Belgium
Amphia Hospital	Breda	The Netherlands
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Germany
Hospital Universitario De La Ribera	Alzira	Spain
Hospital Universitario Hm Puerta Del Sur	Mostoles	Spain
Narodni Ustav Dusevniho Zdravi	Klecany	Czechia
Pneumocare	Namur	Belgium
Uacjwidjwjuroioxfcqdr Ggioucm ulw Mlxgqjo Gtwa	Marburg	Germany
Emkk Pxdgtbqdtzzn Gqvn	Bad Dürrnberg	Austria
Cxrionskr Ugdykkldkwbrvb Stxbsynzm	Woluwe-Saint-Lambert	Belgium
Cxapnek Bfnlf Kmbdbcpbtiz Pfppfuun Son z obhe	Gdansk	Poland
Kywqklcia Ftjxtbkwl Dxmndgi Gkiu	Dresden	Germany
Htdywvfs Vrkz dbaveltr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	04.03.2024
Belgium	Not recruiting	04.03.2024
Czechia	Not recruiting	04.03.2024
Germany	Not recruiting	04.03.2024
Poland	Not recruiting	04.03.2024
Spain	Not recruiting	04.03.2024
The Netherlands	Not recruiting	04.03.2024

Trial locations

Investigated drugs:

Elinzanetant

Elinzanetant is a medication being studied for its potential to help with sleep disturbances that occur during menopause. The trial aims to see how effective and safe this medication is for improving sleep quality in women experiencing menopause-related sleep issues.

Investigated diseases:

Menopausal symptoms

Sleep disturbances associated with menopause – This condition involves difficulties with sleep that occur during menopause, a natural phase in a woman’s life when menstrual cycles end. Common symptoms include trouble falling asleep, staying asleep, or waking up too early. These disturbances are often linked to hormonal changes, particularly the decrease in estrogen levels. Women may experience night sweats and hot flashes, which can further disrupt sleep. The condition can lead to feelings of fatigue and irritability during the day. It is a common issue that affects many women going through menopause.

Trial ID:

2023-504955-28-01

Protocol code:

22423

Trial Phase:

Therapeutic exploratory (Phase II)

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