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

Conditions

• Sleep Disturbances Associated With Menopause

Eligibility Criteria

Sex

FEMALE

Age

40 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Elinzanetant — DRUG
  Oral
• Placebo — OTHER
  Oral

Study Details

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.

Key Dates

First listed

Nov 1, 2023

Start date

Nov 8, 2023

Status verified

Oct 2025

Primary completion

Aug 22, 2024

Completion

Nov 7, 2024

Study Design

Enrollment

110 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elinzanetant arm
  Participants will take Elinzanetant
• Placebo Comparator: Placebo arm
  Participants will take elinzanetant matching placebo

Primary Outcome Measure

Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) [ Time Frame: From baseline until week 4 ]

Locations (22)

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