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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504955-28-00 | Registry Identifier | CTIS (EU) |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elinzanetant arm | Experimental | Participants will take Elinzanetant |
|
| Placebo arm | Placebo Comparator | Participants will take elinzanetant matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elinzanetant | Drug | Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) | 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. | From baseline until week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WASO at Week 12 as Measured by PSG | 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. | From baseline until week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preferred Research Partners | Little Port Walter | Alaska | 72211 | United States | ||
| MomDoc Women's Health Research | Scottsdale, AZ |
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| Label | URL |
|---|---|
| US sites only: Click here for contact | View source |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Out of the 338 screened participants, 110 were randomized and received treatment, and 103 participants completed the study. Among the 228 participants who did not proceed to randomization, screening failure was the primary reason (223 participants).
The study was conducted at 39 study centers, of which 30 centers had randomized participants in Europe and the US. In the US, separate sleep laboratories were used by 9 sites that did not have polysomnography (PSG) capability.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elinzanetant | 120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks |
| FG001 | Placebo | 2 soft gel capsules orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2023 | Aug 21, 2025 |
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| Other |
Oral |
|
| Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG | 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. | From baseline to Week 4 |
| Change From Baseline in SE at Week 12 as Measured by PSG | 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. | From baseline to week 12 |
| 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 | 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. | From baseline until week 4 |
| Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at 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. | From baseline until week 12 |
| Change From Baseline in Insomnia Severity Index (ISI) Total Score at 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. | From baseline until week 4 |
| Change From Baseline in ISI Total Score at 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. | From baseline until week 12 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Diagnamics | Encinitas, CA | Encinitas | California | 92024 | United States |
| SDS Clinical Trials Inc | Santa Ana | California | 92705 | United States |
| Pacific Clinical Research Management Group LLC | Upland | California | 91786 | United States |
| Helix Biomedics LLC | Boynton Beach, FL | Boynton Beach | Florida | 33435 | United States |
| Sweet Hope Research Specialty, Inc. - Hialeah | Hialeah | Florida | 33016 | United States |
| PharmaDev Clinical Research Institute, LLC | Miami | Florida | 33176 | United States |
| Segal Trials - Women's Health & General Medicine Research Site | North Miami | Florida | 33161 | United States |
| Palm Beach Research center | West Palm Beach | Florida | 33409 | United States |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | United States |
| SleepCare Research Institute Inc | Stockbridge | Georgia | 30281 | United States |
| Brengle Family Medicine | Indianapolis | Indiana | 46260 | United States |
| Revive Research Institute, Inc. - Women's Health | Dearborn Heights | Michigan | 48127 | United States |
| Essential Women's Health Associates | Las Vegas | Nevada | 89113 | United States |
| Clinilabs Drug Development Corporation-Feasibility | Eatontown | New Jersey | 07724 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Intrepid Research, LLC. | Cincinnati | Ohio | 45245 | United States |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | United States |
| FutureSearch Trials of Neurology LP | Austin | Texas | 78731 | United States |
| Sleep Therapy and Research Center | Medical Center Drive Office | San Antonio | Texas | 78229 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | United States |
| EMCO Privatklinik | Bad Dürrnberg | State of Salzburg | 5422 | Austria |
| Anima Research Center | Alken | 3570 | Belgium |
| SGS CPU | Edegem | 2650 | Belgium |
| Pneumocare SRL | Erpent | 5101 | Belgium |
| Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre | Leuven | 3000 | Belgium |
| Národní ústav duševního zdraví | Klecany | 250 67 | Czechia |
| Siteworks - Zentrum für klinische Studien Hannover | Hanover | Lower Saxony | 30449 | Germany |
| Klinische Forschung Dresden | Dresden, Germany | Dresden | Saxony | 01069 | Germany |
| ADVANCED SLEEP RESEARCH BERLIN Berlin | Berlin | 10117 | Germany |
| KLIN FORSCHUNG HAMBURG GMBH Hamburg | Hamburg | 20253 | Germany |
| SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin | Schwerin | 19053 | Germany |
| Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii | Warsaw | 02-957 | Poland |
| EMC Instytut Medyczny SA | Wroclaw | 50-220 | Poland |
| Hospital Universitario de La Ribera | Neurophysiology and Sleep Department | Alzira | 46600 | Spain |
| Centro Medico Teknon | Unidad de Medicina del Sueno | Barcelona | 08017 | Spain |
| Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance | Madrid | 28040 | Spain |
| Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance | Móstoles | 28938 | Spain |
| Hospital Universitario de Araba | Santiago Campus - Unidad Sueno | Vitoria-Gasteiz | 01009 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elinzanetant | 120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks |
| BG001 | Placebo | 2 soft gel capsules orally once daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Only female participants enrolled | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight (kg) | Kilograms (Kg) | Mean | Standard Deviation | Kilograms |
| ||||||||||||||
| Height (cm) | Centimeters | Mean | Standard Deviation | Centimeters |
| ||||||||||||||
| Body Mass Index (kg/m2) | Kilogram per square meter | Mean | Standard Deviation | Kilogram per square meter |
| ||||||||||||||
| Average weekly frequency of moderate to severe HF | HF(s) Hot flash(es) | Count of Participants | Participants |
| |||||||||||||||
| Smoking | Count of Participants | Participants |
| ||||||||||||||||
| Alcohol consumption | Count of Participants | Participants |
| ||||||||||||||||
| Caffeine consumption (mg) per day | Mean | Standard Deviation | Miligrams |
| |||||||||||||||
| Level of education | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) | 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. | Posted | Least Squares Mean | Standard Error | Minutes | From baseline until week 4 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in WASO at Week 12 as Measured by PSG | 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. | Posted | Least Squares Mean | Standard Error | Minutes | From baseline until week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG | 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. | Posted | Mean | Standard Deviation | Percentage | From baseline to Week 4 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SE at Week 12 as Measured by PSG | 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. | Posted | Mean | Standard Deviation | Percentage | From baseline to week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | T-Score | From baseline until week 4 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at 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. | Posted | Mean | Standard Deviation | T-Score | From baseline until week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insomnia Severity Index (ISI) Total Score at 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. | Posted | Mean | Standard Deviation | Scores on a scale | From baseline until week 4 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ISI Total Score at 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. | Posted | Mean | Standard Deviation | ISI total score | From baseline until week 12 |
|
|
After the first study intervention up to 113 days until the last follow-up visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BAY 3427080 / Elinzanetant | Soft gel capsule, two capsules of 60 mg | 0 | 55 | 0 | 55 | 24 | 55 |
| EG001 | Placebo | 2 soft gel capsules orally once daily for 12 weeks | 0 | 55 | 2 | 55 | 25 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2024 | Aug 21, 2025 | SAP_001.pdf |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| >=35 - <50 moderate to severe HF per week |
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| >=50 moderate to severe HF per week |
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| Former |
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| Current |
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| Light |
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| College or university education |
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| Professional certification |
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| Attending college |
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| Other |
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| Participants |
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