MedTrace Logo

A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause

NCT06112756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-11-10

Study results available
· View outcomes & findings →

Summary

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.

Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.

The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.

The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.

For this, the researchers will analyze

* change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
* change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
* change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.

The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.

Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.

During the study, the doctors and their study team will:

* take blood and urine samples
* do physical examinations
* check vital signs
* do sleep tests
* use an electronic hand-held device to record sleep quality and hot flashes at home

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Conditions

  • Sleep Disturbances Associated With Menopause

Interventions

DRUG

Elinzanetant

Oral

OTHER

Placebo

Oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2024-08-22
Completion
2024-11-07
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112756 on ClinicalTrials.gov