Clinical trial NCT06112756: A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
Official title: A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disturbances Associated With Menopause
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 110
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in WASO as measured by PSG
timeFrame: At Week 4
Secondary outcomes:
measure: Change from baseline in WASO as measured by PSG
timeFrame: At Week 12
measure: Change from baseline in SE as measured by PSG
timeFrame: At Week 4
measure: Change from baseline in SE as measured by PSG
timeFrame: At Week 12
measure: Change from baseline in PROMIS SD SF 8b total score
timeFrame: At Week 4
measure: Change from baseline in PROMIS SD SF 8b total score
timeFrame: At Week 12
measure: Change from baseline in ISI total score
timeFrame: At Week 4
measure: Change from baseline in ISI total score
timeFrame: At Week 12
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 16 weeks
measure: Number of participants with Abnormal laboratory parameters
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: MomDoc Women's Health Research | Scottsdale, AZ
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Encinitas
country: United States
facility: Diagnamics | Encinitas, CA
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials Inc
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: Boynton Beach
country: United States
facility: Helix Biomedics LLC | Boynton Beach, FL
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc. - Hialeah
state: Florida
city: Miami
country: United States
facility: PharmaDev Clinical Research Institute, LLC
state: Florida
city: North Miami
country: United States
facility: Segal Trials - Women's Health & General Medicine Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research center
state: Florida
city: Macon
country: United States
facility: Sleep Practitioners, LLC
state: Georgia
city: Stockbridge
country: United States
facility: SleepCare Research Institute Inc
state: Georgia
city: Indianapolis
country: United States
facility: Brengle Family Medicine
state: Indiana
city: Dearborn Heights
country: United States
facility: Revive Research Institute, Inc. - Women's Health
state: Michigan
city: Las Vegas
country: United States
facility: Essential Women's Health Associates
state: Nevada
city: Eatontown
country: United States
facility: Clinilabs Drug Development Corporation-Feasibility
state: New Jersey
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research, LLC.
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology LP
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center | Medical Center Drive Office
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: Dürrnberg
country: Austria
facility: EMCO Privatklinik
state: Salzburg
city: Alken
country: Belgium
facility: Anima Research Center
city: Edegem
country: Belgium
facility: SGS CPU
city: Erpent
country: Belgium
facility: Pneumocare SRL
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre
city: Klecany
country: Czechia
facility: Národní ústav duševního zdraví
city: Hannover
country: Germany
facility: Siteworks - Zentrum für klinische Studien Hannover
state: Niedersachsen
city: Dresden
country: Germany
facility: Klinische Forschung Dresden | Dresden, Germany
state: Sachsen
city: Berlin
country: Germany
facility: ADVANCED SLEEP RESEARCH BERLIN Berlin
city: Hamburg
country: Germany
facility: KLIN FORSCHUNG HAMBURG GMBH Hamburg
city: Schwerin
country: Germany
facility: SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin
city: Warszawa
country: Poland
facility: Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny SA
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera | Neurophysiology and Sleep Department
city: Barcelona
country: Spain
facility: Centro Medico Teknon | Unidad de Medicina del Sueno
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance
city: Mostoles
country: Spain
facility: Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario de Araba | Santiago Campus - Unidad Sueno
Study officials:
References: