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

What this trial studies

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.

Conditions in scope

• Sleep Disturbances Associated With Menopause

Interventions

• Elinzanetant (Drug) — Oral
• Placebo (Other) — Oral

Who can join

Women only · Ages 40 Years to 65 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 40 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2023-11-08
• Primary completion: 2024-08-22
• Last update posted: 2025-11-10
• First posted: 2023-11-01

Sponsor & contact

Lead sponsor: Bayer (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.