Trial Condition(s):
Sleep disturbances associated with menopause
A study to learn about how elinzanetant works and how safe it is in women having sleep disturbances associated with menopause (NIRVANA)
Bayer Identifier:
22423
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2023-504955-28-00
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Sleep Therapy and Research Center | Medical Center Drive Office San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations EMCO Privatklinik Bad Duerrnberg, Austria, 5422 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin Schwerin, Germany, 19053 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ADVANCED SLEEP RESEARCH BERLIN Berlin Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Siteworks GmbH Hannover, Germany, 30449 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations EMC Instytut Medyczny SA Wroclaw, Poland, 50-220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii Warszawa, Poland, 02-957 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Medico Teknon | Unidad de Medicina del Sueno Barcelona, Spain, 8022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance Mostoles, Spain, 28938 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario de Araba | Santiago Campus - Unidad Sueno Vitoria-Gasteiz, Spain, 01009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario de La Ribera | Neurophysiology and Sleep Department Alzira, Spain, 46600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinilabs Drug Development Corporation-Feasibility Eatontown, United States, 07724 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Národní ústav duševního zdraví Klecany, Czech Republic, 250 67 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Palm Beach Research center West Palm Beach, United States, 33409 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PharmaDev Clinical Research Institute, LLC Miami, United States, 33176 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CTI Clinical Research Center Cincinnati, United States, 45212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Intrepid Research, LLC. Cincinnati, United States, 45245 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bogan Sleep Consultants, LLC Columbia, United States, 29201 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Preferred Research Partners Little Rock, United States, 72211 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sleep Practitioners, LLC Macon, United States, 31210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FutureSearch Trials of Neurology LP Austin, United States, 78731 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Brengle Family Medicine Indianapolis, United States, 46260 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Road Runner Research, Ltd. San Antonio, United States, 78249 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SleepCare Research Institute Inc Stockbridge, United States, 30281 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Anima Research Center Alken, Belgium, 3570 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pneumocare SRL Erpent, Belgium, 5101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre Leuven, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SGS CPU Edegem, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Segal Trials - Women's Health & General Medicine Research Site North Miami, United States, 33161 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pacific Clinical Research Management Group LLC Upland, United States, 91786 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinische Forschung Dresden | Dresden, Germany Dresden, Germany, 01069 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KLIN FORSCHUNG HAMBURG GMBH Hamburg Hamburg, Germany, 20253 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diagnamics | Encinitas, CA Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Essential Women’s Health Associates Las Vegas, United States, 89113 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Helix Biomedics LLC | Boynton Beach, FL Boynton Beach, United States, 33435 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sweet Hope Research Specialty, Inc. - Hialeah Hialeah, United States, 33016 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Revive Research Institute, Inc. - Women's Health Dearborn Heights, United States, 48127 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MomDoc Women's Health Research | Scottsdale, AZ Scottsdale, United States, 85251 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SDS Clinical Trials Inc Santa Ana, United States, 92705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change from baseline in WASO as measured by PSGWASO: Wakefulness after sleep onset – total number of minutes that a participant is awake after having initially fallen asleep. PSG assessments will be performed on 2 consecutive nights.Timeframe: At Week 4
Secondary Outcome
- Change from baseline in WASO as measured by PSGWASO: Wakefulness after sleep onset – total number of minutes that a participant is awake after having initially fallen asleep. PSG assessments will be performed on 2 consecutive nights.Timeframe: At Week 12
- Change from baseline in SE as measured by PSGSE: Sleep Efficiency – ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.Timeframe: At Week 4
- Change from baseline in SE as measured by PSGSE: Sleep Efficiency – ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.Timeframe: At Week 12
- Change from baseline in PROMIS SD SF 8b total scorePROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b. The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.Timeframe: At Week 4
- Change from baseline in PROMIS SD SF 8b total scorePROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b. The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.Timeframe: At Week 12
- Change from baseline in ISI total scoreISI: Insomnia Severity Index. The ISI is a 7 item instrument that quantifies the participant perception of insomnia severity, along with the impact of insomnia on daytime functioning in adults in the last 2 weeks. The items refer to: severity of sleep onset, sleep maintenance and early morning wakening problems, satisfaction with sleep pattern, noticeability of sleep problems by others, distress caused by the sleep difficulties and interference of sleep difficulties with daytime functioning. It is scored on a 5 point Likert scale from 0 to 4 depending on the item (0=”none”, 4=”very severe” (Items 1–3); 0=”very satisfied”, 4=”very dissatisfied (Item 4)”; 0=”not at all noticeable”, 4=”very much noticeable” (Item 5); 0=”not at all worried”, and 4=”very much worried” (Item 6); 0=”not at all interfering”, 4=”very much interfering” (Item 7)). The scores for each item are summed to produce the total score (maximum 28), higher scores indicates greater severity.Timeframe: At Week 4
- Change from baseline in ISI total scoreISI: Insomnia Severity Index. The ISI is a 7 item instrument that quantifies the participant perception of insomnia severity, along with the impact of insomnia on daytime functioning in adults in the last 2 weeks. The items refer to: severity of sleep onset, sleep maintenance and early morning wakening problems, satisfaction with sleep pattern, noticeability of sleep problems by others, distress caused by the sleep difficulties and interference of sleep difficulties with daytime functioning. It is scored on a 5 point Likert scale from 0 to 4 depending on the item (0=”none”, 4=”very severe” (Items 1–3); 0=”very satisfied”, 4=”very dissatisfied (Item 4)”; 0=”not at all noticeable”, 4=”very much noticeable” (Item 5); 0=”not at all worried”, and 4=”very much worried” (Item 6); 0=”not at all interfering”, 4=”very much interfering” (Item 7)). The scores for each item are summed to produce the total score (maximum 28), higher scores indicates greater severity.Timeframe: At Week 12
- Number of participants with Treatment-emergent Adverse Events (TEAEs)Timeframe: Up to 16 weeks
- Number of participants with Abnormal laboratory parametersTimeframe: Up to 13 weeks
Additional Information
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