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| Name | Class |
|---|---|
| Nerre Therapeutics Ltd. | INDUSTRY |
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This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be dosed for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY3427080 Placebo | Placebo Comparator |
| |
| 50mg BAY3427080 | Experimental |
| |
| 100mg BAY3427080 | Experimental |
| |
| 150mg BAY3427080 | Experimental |
| |
| 300mg BAY3427080 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY3427080 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
| Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Time of occurrence of Cmax.Time to reach maximum plasma concentration of BAY3427080 was presented. Blood samples for Tmax were taken within 30 minutes prior to dose administration. | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose. | Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) |
| Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Area under the concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of BAY3427080 was presented. Blood samples for (AUC0-τ) were taken within 30 minutes prior to dose administration. | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
| Terminal Elimination Half-life (t½) of BAY3427080 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Sternal skin conductance monitors (the Bahr MonitorTM) and the associated algorithm software were supplied by Simplex Scientific LLC (Middleton, USA). Participants were instructed to push a button on the skin conductance monitor when they sensed a hot flush when fitted with the monitor and then provide details of the hot flush in the continuous hot flush diary. Sternal skin conductance monitors were fitted on Day -1 (24 hours±1 hour prior to the planned study drug administration on Day 1) and remained in place until after the Day 7 24-hour assessments were completed (on Day 8). Refitted around 30 minutes prior to study drug administration on Day 14 and remained in place until after the 24-hour assessments were completed on Day 15. |
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Inclusion Criteria:
Post-menopausal female subjects experiencing frequent moderate to severe hot flashes.Menopause will be defined as:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avail Clinical Research | DeLand | Florida | 32720 | United States | ||
| QPS/MRA (Miami Clinical Research) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32068688 | Derived | Trower M, Anderson RA, Ballantyne E, Joffe H, Kerr M, Pawsey S. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause. 2020 May;27(5):498-505. doi: 10.1097/GME.0000000000001500. |
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Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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Overall 316 subjects were screened, of them 240 were screening failure. 76 subjects were randomized and assigned to treatment. 18 subjects were randomized to placebo and 58 subjects to BAY3427080 (NT-814) arms. 2 subjects discontinued the study .
The study was conducted between 01 August 2016 (first subject, screening visit) and 28 March 2017 (last subject, last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Comparator | Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose. |
| FG001 | 50 mg BAY3427080 | 50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| FG002 | 100 mg BAY3427080 | 100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days |
| FG003 | 150 mg BAY3427080 | 150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| FG004 | 300 mg of BAY3427080 | 300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Comparator | Placebo to match BAY3427080 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose. |
| BG001 | 50 mg BAY3427080 | 50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. | Participants who received placebo were not included in the PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
|
Adverse events data were collected on or after first drug administration up to end of study (Day 21).
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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 | Placebo Comparator | Placebo to match BAY3427080 (NT-814) capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
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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 | Dec 13, 2016 | Dec 18, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2017 | Dec 18, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo (for BAY3427080) | Drug |
|
Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
| Apparent Clearance (CL/F) of BAY3427080 | Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
| Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | A physician or appropriately qualified delegate conducted a full physical examination. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). | At day 14 |
| Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). | At day 14 |
| Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Holter monitors were supplied by iCardiac Technologies. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14 and remained in place until 24-hour assessments were completed. | Baseline (day -1) and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Pulse rate was measured just prior to dosing (approx. 30 mins). | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Respiratory rate was measured just prior to dosing (approx. 30 mins). | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Oxygen Saturation was measured just prior to dosing (approx. 30 mins). | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Temperature was measured just prior to dosing (approx. 30 mins). | Baseline and day 14 |
| Change From Baseline at Day 14 in Vital Signs: Weight | Weight was measured just prior to dosing (approx. 30 mins). | Baseline and day 14 |
| Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit. | Baseline and day 15 |
| Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit. | Baseline and day 15 |
| Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit. | Baseline and day 15 |
| Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit. | Baseline and day 15 |
| Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit. | Baseline and day 15 |
| Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Blood samples for the assessment of Cholesterol, Triglycerides,high-density lipoprotein (HDL)Cholesterol and low-density lipoprotein (LDL) Cholesterol were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Blood samples for the assessment of Neutrophils/Leukocytes, Lymphocytes /Leukocytes, Monocytes/Leukocytes, Eosinophils/Leukocytes, Basophils/Leukocytes and Immature Granulocytes/ Leukocytes were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Blood samples for the assessment of Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets were collected upon participant's admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Blood samples for the assessment of Erythrocytes Distribution Width were collected upon participants admission to the unit. Erythrocytes distribution width (in percentage) = 1 SD of Erythrocyte volume/MCV x 100% | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Blood samples for the assessment of Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Blood samples for the assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen were collected upon participant's admission to the unit. | Baseline and day 14 |
| Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit. | At Baseline |
| Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit. | At Baseline |
| Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit. | Baseline and day 14 |
| Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit. | Baseline and day 14 |
| Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Heart rate was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made.Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Baseline (day -1) and day 14 |
| Mean PR Interval - Change From Baseline (Day -1) at Day 14 | PR Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Baseline (day -1) and day 14 |
| Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | QRS Duration was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Baseline (day -1) and day 14 |
| Mean QT Interval - Change From Baseline (Day -1) at Day 14 | QT Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Baseline (day -1) and day 14 |
| Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Fridericia-corrected QTcF interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Baseline (day -1) and day 14 |
| Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Bazett-corrected QTcB interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Baseline (day -1) and day 14 |
| Nature and Severity of Adverse Events (AEs) up to Day 21 | An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event. | On or after first drug administration up to end of study (Day 21). |
| Withdrawals Due to AEs up to Day 21 | An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event. | On or after first drug administration up to end of study (Day 21) |
| Baseline (day -1) and days 7, 14 |
| Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Hot flush frequency and hot flush severity were obtained using the Hot Flush paper Diary. Subjects documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening. | Baseline (week -1) and Week 1 ,Week 2 |
| Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Participants documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening. | Baseline (week -1) and weeks 1, Week 2 |
| Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | The hot flushes severity score was a composite of the frequency and severity of hot flushes, and was calculated as follows: number of mild hot flushes recorded on Day Y + number of moderate hot flushes recorded on Day Y × 2 + number of severe hot flushes recorded on Day Y × 3. Higher scores mean more severe hot flushes. | Baseline (week -1) and week 1 , 2 |
| Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Subjects recorded each hot flush and its severity on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3) in the hot flush paper diary as they occurred during the day and night. | Baseline(day -1) and Day 7, 14 |
| Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | The number of NTAs secondary to hot flushes was the sum of the number of moderate and severe night-time hot flushes recorded the following morning (twice-daily hot flush diary) or recorded contemporaneously on the continuous diary. | Baseline (week-1) and weeks 1 , 2 |
| Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change in Luteinizing Hormone(LH) AUC from time zero to 8 hours. Pre-dose samples for LH were taken within 30 minutes prior to dose administration. | baseline (day-1) to day 1 and day 7, pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) |
| Miami |
| Florida |
| 33143 |
| United States |
| ICON Clinical Research Unit | San Antonio | Texas | 78209 | United States |
| Lost to Follow-up |
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| BG002 | 100 mg BAY3427080 | 100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days |
| BG003 | 150 mg BAY3427080 | 150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| BG004 | 300 mg of BAY3427080 | 300 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| BG005 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| OG002 | 100 mg BAY3427080 | 100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. |
| OG003 | 150 mg BAY3427080 | 150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days |
| OG004 | 300 mg BAY3427080 | 300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days. |
|
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| Primary | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | Time of occurrence of Cmax.Time to reach maximum plasma concentration of BAY3427080 was presented. Blood samples for Tmax were taken within 30 minutes prior to dose administration. | Participants who received placebo were not included in the PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
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| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose. | Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) |
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| Primary | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | Area under the concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of BAY3427080 was presented. Blood samples for (AUC0-τ) were taken within 30 minutes prior to dose administration. | Participants who received placebo were not included in the PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
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| Primary | Terminal Elimination Half-life (t½) of BAY3427080 | Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. | Participants in PK population with available data are reported. Participants who received placebo were not included in the PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
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| Primary | Apparent Clearance (CL/F) of BAY3427080 | Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. | Participants who received placebo were not included in the PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) |
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| Primary | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | A physician or appropriately qualified delegate conducted a full physical examination. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). | Posted | Number | Participants | At day 14 |
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| Primary | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). | Posted | Number | Participants | At day 14 |
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| Primary | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Holter monitors were supplied by iCardiac Technologies. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14 and remained in place until 24-hour assessments were completed. | Posted | Number | Participants | Baseline (day -1) and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. | Posted | Mean | Standard Deviation | mmHg | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. | Posted | Mean | Standard Deviation | mmHg | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. | Posted | Mean | Standard Deviation | mmHg | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. | Posted | Mean | Standard Deviation | mmHg | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Pulse rate was measured just prior to dosing (approx. 30 mins). | Posted | Mean | Standard Deviation | beats/min | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Respiratory rate was measured just prior to dosing (approx. 30 mins). | Posted | Mean | Standard Deviation | breaths/min | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Oxygen Saturation was measured just prior to dosing (approx. 30 mins). | Posted | Mean | Standard Deviation | Percentage of Oxygen satuartion | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Temperature was measured just prior to dosing (approx. 30 mins). | Posted | Mean | Standard Deviation | Degree Celius | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 in Vital Signs: Weight | Weight was measured just prior to dosing (approx. 30 mins). | Posted | Mean | Standard Deviation | Kilograms | Baseline and day 14 |
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| Primary | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | pmol/L | Baseline and day 15 |
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| Primary | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit. | Posted | Mean | Standard Deviation | IU/L | Baseline and day 15 |
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| Primary | Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake | Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit. | Participants in PK analysis set with evaluable data for this outcome measure presented. | Posted | Mean | Standard Deviation | Percentage of T Uptake | Baseline and day 15 |
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| Primary | Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin | Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit. | Posted | Mean | Standard Deviation | mIU/L | Baseline and day 15 |
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| Primary | Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine | Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | nmol/L | Baseline and day 15 |
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| Primary | Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. | Blood samples for the assessment of Cholesterol, Triglycerides,high-density lipoprotein (HDL)Cholesterol and low-density lipoprotein (LDL) Cholesterol were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | mmol/L | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. | Blood samples for the assessment of Neutrophils/Leukocytes, Lymphocytes /Leukocytes, Monocytes/Leukocytes, Eosinophils/Leukocytes, Basophils/Leukocytes and Immature Granulocytes/ Leukocytes were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | Percentage of total white blood cells | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. | Blood samples for the assessment of Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets were collected upon participant's admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | 10^9*cells/L | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration | Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | g/L | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes | Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | 10^12*cells/L | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. | Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | fL | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | pg | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. | Blood samples for the assessment of Erythrocytes Distribution Width were collected upon participants admission to the unit. Erythrocytes distribution width (in percentage) = 1 SD of Erythrocyte volume/MCV x 100% | Participants with available data reported. | Posted | Mean | Standard Deviation | Percentage of Erythrocyte volume | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. | Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | Volume percentage | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. | Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | g/L | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase | Blood samples for the assessment of Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | ukat/L | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. | Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | umol/L | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. | Blood samples for the assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen were collected upon participant's admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | mmol/L | Baseline and day 14 |
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| Primary | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline | Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit. | Participants with available data reported. Baseline is the last available measurement prior to the first dose of study drug. | Posted | Mean | Standard Deviation | mL/sec/1.73m^2 | At Baseline |
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| Primary | Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline | Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit. | Participants with available data reported. Baseline is the last available measurement prior to the first dose of study drug. | Posted | Mean | Standard Deviation | mL/sec/1.73m^2 | At Baseline |
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| Primary | Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) | Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | INR | Baseline and day 14 |
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| Primary | Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time | Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit. | Participants with available data reported. | Posted | Mean | Standard Deviation | sec | Baseline and day 14 |
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| Primary | Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 | Heart rate was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made.Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Participants with available data reported. | Posted | Mean | Standard Deviation | beats/min | Baseline (day -1) and day 14 |
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| Primary | Mean PR Interval - Change From Baseline (Day -1) at Day 14 | PR Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Participants with available data reported. | Posted | Mean | Standard Deviation | msec | Baseline (day -1) and day 14 |
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| Primary | Mean QRS Duration - Change From Baseline (Day -1) at Day 14 | QRS Duration was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Participants with available data reported. | Posted | Mean | Standard Deviation | msec | Baseline (day -1) and day 14 |
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| Primary | Mean QT Interval - Change From Baseline (Day -1) at Day 14 | QT Interval was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Participants with available data reported. | Posted | Mean | Standard Deviation | msec | Baseline (day -1) and day 14 |
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| Primary | Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 | Fridericia-corrected QTcF interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Participants with available data reported. | Posted | Mean | Standard Deviation | msec | Baseline (day -1) and day 14 |
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| Primary | Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 | Bazett-corrected QTcB interval was evaluated as part of the 12-lead electrocardiogram. Resting ECG recordings were made. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14. | Participants with available data reported. | Posted | Mean | Standard Deviation | msec | Baseline (day -1) and day 14 |
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| Primary | Nature and Severity of Adverse Events (AEs) up to Day 21 | An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event. | Posted | Number | Participants | On or after first drug administration up to end of study (Day 21). |
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| Primary | Withdrawals Due to AEs up to Day 21 | An AE was defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. Serious Adverse Event (SAE) is an adverse event that at any dose: Results in death, Is life-threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe), Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is considered to be an important medical event. | Posted | Number | Participants | On or after first drug administration up to end of study (Day 21) |
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| Secondary | Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance | Sternal skin conductance monitors (the Bahr MonitorTM) and the associated algorithm software were supplied by Simplex Scientific LLC (Middleton, USA). Participants were instructed to push a button on the skin conductance monitor when they sensed a hot flush when fitted with the monitor and then provide details of the hot flush in the continuous hot flush diary. Sternal skin conductance monitors were fitted on Day -1 (24 hours±1 hour prior to the planned study drug administration on Day 1) and remained in place until after the Day 7 24-hour assessments were completed (on Day 8). Refitted around 30 minutes prior to study drug administration on Day 14 and remained in place until after the 24-hour assessments were completed on Day 15. | Participants with available data reported. | Posted | Mean | Standard Deviation | Hot flushes | Baseline (day -1) and days 7, 14 |
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| Secondary | Change From Baseline (Week -1) at Weeks 1, 2 in Frequency of Moderate to Severe Hot Flushes as Measured by Twice Daily Paper Diary Throughout Study | Hot flush frequency and hot flush severity were obtained using the Hot Flush paper Diary. Subjects documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening. | Posted | Mean | Standard Deviation | Hot flushes | Baseline (week -1) and Week 1 ,Week 2 |
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| Secondary | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary | Participants documented the number of individual hot flushes experienced and rated the severity of each on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3). The diaries were completed based on recall twice daily, in the morning and evening. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (week -1) and weeks 1, Week 2 |
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| Secondary | Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. | The hot flushes severity score was a composite of the frequency and severity of hot flushes, and was calculated as follows: number of mild hot flushes recorded on Day Y + number of moderate hot flushes recorded on Day Y × 2 + number of severe hot flushes recorded on Day Y × 3. Higher scores mean more severe hot flushes. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (week -1) and week 1 , 2 |
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| Secondary | Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. | Subjects recorded each hot flush and its severity on a scale of 1 to 3 (mild = 1, moderate = 2, severe = 3) in the hot flush paper diary as they occurred during the day and night. | Participants with available data reported. | Posted | Least Squares Mean | 90% Confidence Interval | Hot flushes | Baseline(day -1) and Day 7, 14 |
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| Secondary | Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary | The number of NTAs secondary to hot flushes was the sum of the number of moderate and severe night-time hot flushes recorded the following morning (twice-daily hot flush diary) or recorded contemporaneously on the continuous diary. | Posted | Mean | Standard Deviation | Night-time Awakenings | Baseline (week-1) and weeks 1 , 2 |
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| Secondary | Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) | Change in Luteinizing Hormone(LH) AUC from time zero to 8 hours. Pre-dose samples for LH were taken within 30 minutes prior to dose administration. | Posted | Mean | Standard Deviation | h*U/L | baseline (day-1) to day 1 and day 7, pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) |
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| 0 |
| 18 |
| 0 |
| 18 |
| 13 |
| 18 |
| EG001 | 50 mg BAY3427080 | 50mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. | 0 | 15 | 0 | 15 | 7 | 15 |
| EG002 | 100 mg BAY3427080 | 100 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days. | 0 | 15 | 0 | 15 | 11 | 15 |
| EG003 | 150 mg BAY3427080 | 150 mg of BAY3427080 to be administered as oral capsules, daily, for 14 days | 0 | 15 | 0 | 15 | 10 | 15 |
| EG004 | 300 mg BAY3427080 | 300 mg BAY3427080 to be administered as oral capsules, daily, for 14 days. | 0 | 13 | 0 | 13 | 11 | 13 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Medical device site irritation | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Medical device site pruritus | General disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (20.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
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The PI is required to postpone communication of results until a joint, multicenter publication of the multicenter study has occurred, or the sponsor confirms that no joint publication will be prepared, or 18 months since completion of the data analysis have passed.
The sponsor can review planned publications for up to 60 days and request reasonable amendments. The review period can be extended by up to 6 months in case a patent application is planned.
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| Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1) |
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| Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1) |
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| Other arrhythmias (Day-1) |
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| Second Degree AV Block - Type I (Day-1) |
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| Sinus Bradycardia (HR < 40 bpm)(Day-1) |
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| SupraVentricular Tachycardia (lasting > 10 beats) (Day-1) |
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| At least three monomorphic beats in a row (Day 14) |
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| Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14) |
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| Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14) |
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| Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14) |
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| Other arrhythmias (Day 14) |
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| Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14) |
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| Second Degree AV Block - Type I (Day 14) |
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| Second Degree AV Block - Type II(Day 14) |
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| Sinus Bradycardia (HR < 40 bpm) |
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| SupraVentricular Tachycardia (lasting > 10 beats (Day 14) |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 15 Change from Baseline (ADTH) |
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| Baseline (Estradiol) |
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| Day 15 Change from Baseline (Estradiol) |
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| Day 15 Change from Baseline |
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| Day 15 Change from Baseline |
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| Day 15 Change from Baseline |
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| Day 15 Change from Baseline (Cortisol) |
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| Baseline (Testosterone) |
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| Day 15 Change from Baseline (Testosterone) |
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| Baseline(Thyroxine) |
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| Day 15 Change from Baseline(Thyroxine) |
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| Baseline(Triiodothyronine) |
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| Day 15 Change from Baseline (Triiodothyronine) |
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| Day 14 Change from Baseline (Cholesterol) |
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| Baseline (Triglycerides) |
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| Day 14 Change from Baseline (Triglycerides) |
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| Baseline(HDL Cholesterol) |
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| Day 14 Change from Baseline( HDL Cholesterol) |
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| Baseline( LDL Cholesterol) |
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| Day 14 Change from Baseline ( LDL Cholesterol) |
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| Day 14 Change from Baseline (Neutrophils/ Leukocytes) |
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| Baseline (Lymphocytes/ Leukocytes) |
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| Day 14 Change from Baseline(Lymphocytes / Leukocytes) |
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| Baseline ( Monocytes / Leukocytes ) |
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| Day 14 Change from Baseline( Monocytes/ Leukocytes) |
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| Baseline ( Eosinophils/ Leukocytes) |
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| Day 14 Change from Baseline(Eosinophils/ Leukocytes) |
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| Baseline(Basophils/ Leukocytes) |
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| Day 14 Change from Baseline (Basophils/ Leukocytes) |
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| Baseline( Immature Granulocytes/ Leukocytes) |
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| Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes) |
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| Day 14 Change from Baseline( Leukocytes) |
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| Baseline (Neutrophils) |
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| Day 14 Change from Baseline (Neutrophils ) |
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| Baseline (Lymphocytes) |
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| Day 14 Change from Baseline (Lymphocytes) |
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| Baseline ( Monocytes) |
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| Day 14 Change from Baseline( Monocytes) |
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| Baseline ( Eosinophils) |
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| Day 14 Change from Baseline(Eosinophils) |
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| Baseline(Basophils) |
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| Day 14 Change from Baseline(Basophils) |
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| Baseline( Immature Granulocytes) |
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| Day 14 Change from Baseline( Immature Granulocytes) |
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| Baseline (Platelets ) |
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| Day 14 Change from Baseline(Platelets ) |
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| Day 14 Change from Baseline (Hemoglobin) |
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| Baseline (Erythrocytes Mean Corpuscular HB concentration ) |
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| Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration) |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume ) |
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| Baseline (Mean Platelet Volume) |
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| Day 14 Change from Baseline (Mean Platelet Volume) |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline(Protein) |
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| Baseline(Albumin) |
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| Day 14 Change from Baseline (Albumin) |
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| Day 14 Change from Baseline (Alkaline Phosphatase) |
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| Baseline(Alanine Aminotransferase) |
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| Day 14 Change from Baseline (Alanine Aminotransferase) |
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| Baseline (Aspartate Aminotransferase) |
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| Day 14 Change from Baseline (Aspartate Aminotransferase) |
|
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| Baseline (Gamma Glutamyl Transferase) |
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| Day 14 Change from Baseline (Gamma Glutamyl Transferase) |
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| Baseline (Creatine Kinase) |
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| Day 14 Change from Baseline (Creatine Kinase) |
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| Day 14 Change from Baseline (Urate) |
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| Baseline (Bilirubin) |
|
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| Day 14 Change from Baseline(Bilirubin) |
|
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| Baseline(Creatinine) |
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| Day 14 Change from Baseline(Creatinine) |
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| Day 14 Change from Baseline (Sodium) |
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| Baseline (Potassium) |
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| Day 14 Change from Baseline (Potassium) |
|
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| Baseline (Chloride) |
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| Day 14 Change from Baseline ( Chloride) |
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| Baseline (Bicarbonate) |
|
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| Day 14 Change from Baseline (Bicarbonate) |
|
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| Baseline (Calcium) |
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| Day 14 Change from Baseline (Calcium) |
|
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| Baseline (Phosphate) |
|
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| Day 14 Change from Baseline (Phosphate) |
|
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| Baseline (Glucose) |
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| Day 14 Change from Baseline (Glucose) |
|
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| Baseline (Magnesium) |
|
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| Day 14 Change from Baseline (Magnesium) |
|
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| Baseline (Urea Nitrogen) |
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| Day 14 Change from Baseline (Urea Nitrogen) |
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| Day 14 Change from Baseline |
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| Day 14 Change from Baseline (Prothrombin Time) |
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| Baseline(Activated Partial Thromboplastin Time) |
|
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| Day 14 Change from Baseline (Activated Partial Thromboplastin Time) |
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| Day -1 (0.5 hour) |
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| Day -1 (1 hour) |
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| Day -1 (1.5 hour) |
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| Day -1 (2 hour) |
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| Day -1 (2.5 hour) |
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| Day -1 (3 hour) |
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| Day -1 (4 hour) |
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| Day -1 (8 hour) |
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| Day -1 (12 hour) |
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| Day 14 (Pre dose) Change from Baseline |
|
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| Day 14 (0.5 hour) Change from Baseline |
|
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| Day 14 (1 hour) Change from Baseline |
|
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| Day 14 (1.5 hour) Change from Baseline |
|
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| Day 14 (2 hour) Change from Baseline |
|
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| Day 14 (2.5 hour) Change from Baseline |
|
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| Day 14 (3 hour) Change from Baseline |
|
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| Day 14 (4 hour) Change from Baseline |
|
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| Day 14 (8 hour) Change from Baseline |
|
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| Day 14 (12 hour) Change from Baseline |
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|
|
| Day -1 (0.5 hour) |
|
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| Day -1 (1 hour) |
|
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| Day -1 (1.5 hour) |
|
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| Day -1 (2 hour) |
|
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| Day -1 (2.5 hour) |
|
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| Day -1 (3 hour) |
|
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| Day -1 (4 hour) |
|
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| Day -1 (8 hour) |
|
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| Day -1 (12 hour) |
|
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| Day 14 (Pre dose) Change from Baseline |
|
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| Day 14 (0.5 hour) Change from Baseline |
|
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| Day 14 (1 hour) Change from Baseline |
|
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| Day 14 (1.5 hour) Change from Baseline |
|
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| Day 14 (2 hour) Change from Baseline |
|
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| Day 14 (2.5 hour) Change from Baseline |
|
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| Day 14 (3 hour) Change from Baseline |
|
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| Day 14 (4 hour) Change from Baseline |
|
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| Day 14 (8 hour) Change from Baseline |
|
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| Day 14 (12 hour) Change from Baseline |
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|
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| Day -1 (0.5 hour |
|
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| Day -1 (1 hour) |
|
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| Day -1 (1.5 hour) |
|
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| Day -1 (2 hour) |
|
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| Day -1 (2.5 hour) |
|
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| Day -1 (3 hour) |
|
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| Day -1 (4 hour) |
|
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| Day -1 (8 hour) |
|
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| Day -1 (12 hour) |
|
|
| Day 14 (Pre dose) Change from Baseline |
|
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| Day 14 (0.5 hour) Change from Baseline |
|
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| Day 14 (1 hour) Change from Baseline |
|
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| Day 14 (1.5 hour) Change from Baseline |
|
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| Day 14 (2 hour) Change from Baseline |
|
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| Day 14 (2.5 hour) Change from Baseline |
|
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| Day 14 (3 hour) Change from Baseline |
|
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| Day 14 (4 hour) Change from Baseline |
|
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| Day 14 (8 hour) Change from Baseline |
|
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| Day 14 (12 hour) Change from Baseline |
|
|
|
| Day -1 (0.5 hour |
|
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| Day -1 (1 hour) |
|
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| Day -1 (1.5 hour) |
|
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| Day -1 (2 hour) |
|
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| Day -1 (2.5 hour) |
|
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| Day -1 (3 hour) |
|
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| Day -1 (4 hour) |
|
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| Day -1 (8 hour) |
|
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| Day -1 (12 hour) |
|
|
| Day 14 (Pre dose) Change from Baseline |
|
|
| Day 14 (0.5 hour) Change from Baseline |
|
|
| Day 14 (1 hour) Change from Baseline |
|
|
| Day 14 (1.5 hour) Change from Baseline |
|
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| Day 14 (2 hour) Change from Baseline |
|
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| Day 14 (2.5 hour) Change from Baseline |
|
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| Day 14 (3 hour) Change from Baseline |
|
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| Day 14 (4 hour) Change from Baseline |
|
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| Day 14 (8 hour) Change from Baseline |
|
|
| Day 14 (12 hour) Change from Baseline |
|
|
|
| Day -1 (0.5 hour) |
|
|
| Day -1 (1 hour) |
|
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| Day -1 (1.5 hour) |
|
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| Day -1 (2 hour) |
|
|
| Day -1 (2.5 hour) |
|
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| Day -1 (3 hour) |
|
|
| Day -1 (4 hour) |
|
|
| Day -1 (8 hour) |
|
|
| Day -1 (12 hour) |
|
|
| Day 14 (Pre dose) Change from Baseline |
|
|
| Day 14 (0.5 hour) Change from Baseline |
|
|
| Day 14 (1 hour) Change from Baseline |
|
|
| Day 14 (1.5 hour) Change from Baseline |
|
|
| Day 14 (2 hour) Change from Baseline |
|
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| Day 14 (2.5 hour) Change from Baseline |
|
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| Day 14 (3 hour) Change from Baseline |
|
|
| Day 14 (4 hour) Change from Baseline |
|
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| Day 14 (8 hour) Change from Baseline |
|
|
| Day 14 (12 hour) Change from Baseline |
|
|
|
| Day -1 (0.5 hour) |
|
|
| Day -1 (1 hour) |
|
|
| Day -1 (1.5 hour) |
|
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| Day -1 (2 hour) |
|
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| Day -1 (2.5 hour) |
|
|
| Day -1 (3 hour) |
|
|
| Day -1 (4 hour) |
|
|
| Day -1 (8 hour) |
|
|
| Day -1 (12 hour) |
|
|
| Day 14 (Pre dose) Change from Baseline |
|
|
| Day 14 (0.5 hour) Change from Baseline |
|
|
| Day 14 (1 hour) Change from Baseline |
|
|
| Day 14 (1.5 hour) Change from Baseline |
|
|
| Day 14 (2 hour) Change from Baseline |
|
|
| Day 14 (2.5 hour) Change from Baseline |
|
|
| Day 14 (3 hour) Change from Baseline |
|
|
| Day 14 (4 hour) Change from Baseline |
|
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| Day 14 (8 hour) Change from Baseline |
|
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| Day 14 (12 hour) Change from Baseline |
|
|
| Any Mild TEAE |
|
| Any Moderate TEAE |
|
| Any Severe TEAE |
|
| Any serious TEAE |
|
| Any Causally Related TEAE |
|
| Any Causally Related Serious TEAE |
|
| Any Life Threatening Serious TEAE |
|
| Any TEAE of Dehydration |
|
| Any Death |
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| Any TEAE Leading to Study Discontinuation |
|
|
| Change from Day -1 to Day 7 |
|
|
| Change from Day -1 to day 14 |
|
|
| Change from Week -1 to Week 1 |
|
| Change from Week -1 to Week 2 |
|
| Change from Week -1 to Week 1 |
|
| Change from Week -1 to Week 2 |
|
| LS means difference |
| 0.9894 |
| Linear mixed-effects model |
| 0.00 |
| Standard Error of the Mean |
| 0.128 |
| 2-Sided |
| 90 |
| -0.21 |
| 0.21 |
Change from Week -1 to Week 1 |
| Other |
Descriptive Analysis |
| Linear mixed-effects model | 0.0199 | LS means difference | -0.31 | Standard Error of the Mean | 0.129 | 2-Sided | 90 | -0.52 | -0.09 | Change from Week -1 to Week 1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.3907 | LS means difference | -0.12 | Standard Error of the Mean | 0.133 | 2-Sided | 90 | -0.34 | 0.11 | Change from Week -1 to Week 1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.5393 | LS means difference | 0.10 | Standard Error of the Mean | 0.166 | 2-Sided | 90 | -0.17 | 0.38 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.7931 | LS means difference | -0.04 | Standard Error of the Mean | 0.169 | 2-Sided | 90 | -0.33 | 0.24 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0004 | LS means difference | -0.63 | Standard Error of the Mean | 0.169 | 2-Sided | 90 | -0.92 | -0.35 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.3739 | LS means difference | -0.16 | Standard Error of the Mean | 0.175 | 2-Sided | 90 | -0.45 | 0.13 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Change from Week -1 to Week 1 |
|
| Change from Week -1 to Week 2 |
|
| Linear mixed-effects model |
| 0.1487 |
| LS means difference |
| -4.46 |
| Standard Error of the Mean |
| 3.053 |
| 2-Sided |
| 90 |
| -9.55 |
| 0.63 |
Change from Week -1 to Week 1 |
| Other |
Descriptive Analysis |
| Linear mixed-effects model | 0.0012 | LS means difference | -10.18 | Standard Error of the Mean | 3.015 | 2-Sided | 90 | -15.20 | -5.15 | Change from Week -1 to Week 1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0548 | LS means difference | -6.14 | Standard Error of the Mean | 3.142 | 2-Sided | 90 | -11.37 | -0.90 | Change from Week -1 to Week 1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0522 | LS means difference | 6.59 | Standard Error of the Mean | 3.337 | 2-Sided | 90 | 1.03 | 12.15 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.1326 | LS means difference | -5.07 | Standard Error of the Mean | 3.329 | 2-Sided | 90 | -10.61 | 0.48 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0004 | LS means difference | -12.28 | Standard Error of the Mean | 3.270 | 2-Sided | 90 | -17.73 | -6.83 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0253 | LS means difference | -7.79 | Standard Error of the Mean | 3.408 | 2-Sided | 90 | -13.47 | -2.11 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Day 14 Change from Day -1 |
|
| Linear mixed-effects model |
| 0.1413 |
| LS means difference |
| -2.3 |
| Standard Error of the Mean |
| 1.55 |
| 2-Sided |
| 90 |
| -4.9 |
| 0.3 |
Day 7 Change from Day -1 |
| Other |
Descriptive Analysis |
| Linear mixed-effects model | 0.0007 | LS means difference | -5.5 | Standard Error of the Mean | 1.55 | 2-Sided | 90 | -8.1 | -2.9 | Day 7 Change from Day -1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0624 | LS means difference | -3.1 | Standard Error of the Mean | 1.62 | 2-Sided | 90 | -5.8 | -0.4 | Day 7 Change from Day -1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.2930 | LS means difference | 1.3 | Standard Error of the Mean | 1.21 | 2-Sided | 90 | -0.7 | 3.3 | Day 14 Change from Day -1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0512 | LS means difference | -2.4 | Standard Error of the Mean | 1.21 | 2-Sided | 90 | -4.4 | -0.4 | Day 14 Change from Day -1 | Other | Descriptive Analysis |
| Linear mixed-effects model | <0.0001 | LS means difference | -5.0 | Standard Error of the Mean | 1.20 | 2-Sided | 90 | -7.0 | -3.0 | Day 14 Change from Day -1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0080 | LS means difference | -3.4 | Standard Error of the Mean | 1.25 | 2-Sided | 90 | -5.5 | -1.3 | Day 14 Change from Day -1 | Other | Descriptive Analysis |
| Change from Week -1 to Week 1 |
|
| Change from Week -1 to Week 2 |
|
| Linear mixed-effects model |
| 0.0734 |
| LS means difference |
| -1.04 |
| Standard Error of the Mean |
| 0.571 |
| 2-Sided |
| 90 |
| -1.99 |
| -0.09 |
Change from Week -1 to Week 1 |
| Other |
Descriptive Analysis |
| Linear mixed-effects model | 0.0022 | LS means difference | -1.80 | Standard Error of the Mean | 0.565 | 2-Sided | 90 | -2.74 | -0.86 | Change from Week -1 to Week 1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0660 | LS means difference | -1.10 | Standard Error of the Mean | 0.589 | 2-Sided | 90 | -2.08 | -0.12 | Change from Week -1 to Week 1 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0593 | LS means difference | 1.18 | Standard Error of the Mean | 0.613 | 2-Sided | 90 | 0.15 | 2.20 | Other | Descriptive Analysis | Change from Week -1 to Week 2 |
| Linear mixed-effects model | 0.1354 | LS means difference | -0.93 | Standard Error of the Mean | 0.614 | 2-Sided | 90 | -1.95 | 0.10 | Change from Week -1 to Week 2 | Other |
| Linear mixed-effects model | 0.0005 | LS means difference | -2.20 | Standard Error of the Mean | 0.603 | 2-Sided | 90 | -3.21 | -1.20 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Linear mixed-effects model | 0.0309 | LS means difference | -1.38 | Standard Error of the Mean | 0.628 | 2-Sided | 90 | -2.43 | -0.34 | Change from Week -1 to Week 2 | Other | Descriptive Analysis |
| Change from Day -1 to Day 1 |
|
| Change from Day -1 to Day 7 |
|
| Linear mixed-effects model |
| 0.0248 |
| LS means difference |
| -25.0 |
| Standard Error of the Mean |
| 10.89 |
| 2-Sided |
| 90 |
| -43.1 |
| -6.8 |
Change from Day -1 to Day 1 |
| Other |
Descriptive analysis |
| Linear mixed-effects model | 0.0001 | LS means difference | -43.9 | Standard Error of the Mean | 10.90 | 2-Sided | 90 | -62.1 | -25.8 | Change from Day -1 to Day 1 | Other | Descriptive analysis |
| Linear mixed-effects model | 0.0004 | LS means difference | -42.9 | Standard Error of the Mean | 11.43 | 2-Sided | 90 | -61.9 | -23.8 | Change from Day -1 to Day 1 | Other | Descriptive analysis |
| Linear mixed-effects model | 0.4819 | LS means difference | 10.4 | Standard Error of the Mean | 14.76 | 2-Sided | 90 | -14.2 | 35.1 | Change from Day -1 to Day 7 | Other | Descriptive analysis |
| Linear mixed-effects model | 0.8694 | LS means difference | -2.4 | Standard Error of the Mean | 14.77 | 2-Sided | 90 | -27.1 | 22.2 | Change from Day -1 to Day 7 | Other | Descriptive analysis |
| Linear mixed-effects model | 0.1105 | LS means difference | -23.9 | Standard Error of the Mean | 14.79 | 2-Sided | 90 | -48.6 | 0.7 | Change from Day -1 to Day 7 | Other | Descriptive analysis |
| Linear mixed-effects model | 0.2390 | LS means difference | -18.4 | Standard Error of the Mean | 15.50 | 2-Sided | 90 | -44.2 | 7.4 | Change from Day -1 to Day 7 | Other | Descriptive analysis |