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

Phase 2

Completed

Conditions: Sleep Disturbances Associated With Menopause

Interventions: Other: Placebo
Drug: Elinzanetant

Registration Number: NCT06112756

Lead Sponsor: Bayer

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 110

Inclusion Criteria

Females aged 40 to 65 years, inclusive, at signing of informed consent.
Being in the post-menopausal period, defined as: serum FSH levels >40 mIU/mL and a serum estradiol concentration of <30 pg/mL at screening, AND Hysterectomy performed at least 6 weeks prior to screening.
The participant's self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep.
WASO of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights <20 min).

Exclusion Criteria

Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder).
Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
Renal impairment greater than moderate (i.e. estimated glomerular filtration rate <30 mL/min/1.73 m^2) at screening

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	Participants will take elinzanetant matching placebo
Elinzanetant arm	Elinzanetant	Participants will take Elinzanetant

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG)	From baseline until week 4	WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in SE at Week 12 as Measured by PSG	From baseline to week 12	Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.
Change From Baseline in WASO at Week 12 as Measured by PSG	From baseline until week 12	WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.
Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG	From baseline to Week 4	Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.
Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 4	From baseline until week 4	Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12	From baseline until week 12	Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4	From baseline until week 4	Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.
Change From Baseline in ISI Total Score at Week 12	From baseline until week 12	Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.

Trial Locations

Locations (40): Preferred Research Partners
🇺🇸
Little Port Walter, Alaska, United States
MomDoc Women's Health Research | Scottsdale, AZ
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Scottsdale, Arizona, United States
Diagnamics | Encinitas, CA
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Encinitas, California, United States
SDS Clinical Trials Inc
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Santa Ana, California, United States
Pacific Clinical Research Management Group LLC
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Upland, California, United States
Helix Biomedics LLC | Boynton Beach, FL
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Boynton Beach, Florida, United States
Sweet Hope Research Specialty, Inc. - Hialeah
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Hialeah, Florida, United States
PharmaDev Clinical Research Institute, LLC
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Miami, Florida, United States
Segal Trials - Women's Health & General Medicine Research Site
🇺🇸
North Miami, Florida, United States
Palm Beach Research center
🇺🇸
West Palm Beach, Florida, United States
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Preferred Research Partners
🇺🇸Little Port Walter, Alaska, United States