Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (RELENT-1)

• ClinicalTrials.gov Identifier: NCT02865538
• Recruitment Status: Completed
• First Posted: August 12, 2016
• Results First Posted: February 16, 2021
• Last Update Posted: February 16, 2021
• Sponsor: Bayer
• Collaborator: Nerre Therapeutics Ltd.
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Post-menopausal Vasomotor Symptoms	Drug: BAY3427080; Drug: Placebo (for BAY3427080)	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Pharmacokinetics and Safety of NT-814 in Post-Menopausal Women With Vasomotor Symptoms
• Actual Study Start Date: August 1, 2016
• Actual Primary Completion Date: March 28, 2017
• Actual Study Completion Date: March 28, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: BAY3427080 Placebo	Drug: Placebo (for BAY3427080)
Experimental: 50mg BAY3427080	Drug: BAY3427080; Other Name: NT-814
Experimental: 100mg BAY3427080	Drug: BAY3427080; Other Name: NT-814
Experimental: 150mg BAY3427080	Drug: BAY3427080; Other Name: NT-814
Experimental: 300mg BAY3427080	Drug: BAY3427080; Other Name: NT-814

Outcome Measures

Primary Outcome Measures :

1. Maximum Observed Plasma Concentration (Cmax) of BAY3427080 [ Time Frame: 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) ]
   Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
2. Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 [ Time Frame: 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 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.
3. Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 [ Time Frame: 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) ]
   AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose.
4. Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 [ Time Frame: 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 (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.
5. Terminal Elimination Half-life (t½) of BAY3427080 [ Time Frame: 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 of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
6. Apparent Clearance (CL/F) of BAY3427080 [ Time Frame: 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 of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
7. Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. [ Time Frame: At day 14 ]
   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).
8. Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs [ Time Frame: At day 14 ]
   Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).
9. Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. [ Time Frame: Baseline (day -1) and day 14 ]
   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.
10. Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) [ Time Frame: Baseline and day 14 ]
    Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.
11. Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) [ Time Frame: Baseline and day 14 ]
    Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.
12. Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) [ Time Frame: Baseline and day 14 ]
    Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.
13. Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) [ Time Frame: Baseline and day 14 ]
    Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.
14. Change From Baseline at Day 14 in Vital Signs: Pulse Rate [ Time Frame: Baseline and day 14 ]
    Pulse rate was measured just prior to dosing (approx. 30 mins).
15. Change From Baseline at Day 14 in Vital Signs: Respiratory Rate [ Time Frame: Baseline and day 14 ]
    Respiratory rate was measured just prior to dosing (approx. 30 mins).
16. Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation [ Time Frame: Baseline and day 14 ]
    Oxygen Saturation was measured just prior to dosing (approx. 30 mins).
17. Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature [ Time Frame: Baseline and day 14 ]
    Temperature was measured just prior to dosing (approx. 30 mins).
18. Change From Baseline at Day 14 in Vital Signs: Weight [ Time Frame: Baseline and day 14 ]
    Weight was measured just prior to dosing (approx. 30 mins).
19. Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. [ Time Frame: Baseline and day 15 ]
    Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit.
20. Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone [ Time Frame: Baseline and day 15 ]
    Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit.
21. Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake [ Time Frame: Baseline and day 15 ]
    Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit.
22. Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin [ Time Frame: Baseline and day 15 ]
    Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit.
23. Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine [ Time Frame: Baseline and day 15 ]
    Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit.
24. Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol. [ Time Frame: Baseline and day 14 ]
    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.
25. Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes. [ Time Frame: Baseline and day 14 ]
    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.
26. Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets. [ Time Frame: Baseline and day 14 ]
    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.
27. Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit.
28. Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit.
29. Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume. [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit.
30. Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit.
31. Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width. [ Time Frame: Baseline and day 14 ]
    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%
32. Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit. [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit.
33. Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin. [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit.
34. Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase [ Time Frame: Baseline and day 14 ]
    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.
35. Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine. [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit.
36. Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen. [ Time Frame: Baseline and day 14 ]
    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.
37. Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline [ Time Frame: At Baseline ]
    Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit.
38. Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline [ Time Frame: At Baseline ]
    Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit.
39. Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR) [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit.
40. Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time [ Time Frame: Baseline and day 14 ]
    Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit.
41. Heart Rate (HR) - Change From Baseline (Day -1) at Day 14 [ Time Frame: Baseline (day -1) and 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.
42. Mean PR Interval - Change From Baseline (Day -1) at Day 14 [ Time Frame: Baseline (day -1) and 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.
43. Mean QRS Duration - Change From Baseline (Day -1) at Day 14 [ Time Frame: Baseline (day -1) and 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.
44. Mean QT Interval - Change From Baseline (Day -1) at Day 14 [ Time Frame: Baseline (day -1) and 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.
45. Mean QTcF Interval (Fridericia's Correction Formula, QTcF) - Change From Baseline (Day -1) at Day 14 [ Time Frame: Baseline (day -1) and 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.
46. Mean QTcB Interval (Bazett's Correction Formula, QTcB) - Change From Baseline (Day -1) at Day 14 [ Time Frame: Baseline (day -1) and 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.
47. Nature and Severity of Adverse Events (AEs) up to Day 21 [ Time Frame: On or after first drug administration up to end of study (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.

48. Withdrawals Due to AEs up to Day 21 [ Time Frame: On or after first drug administration up to end of study (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.

Secondary Outcome Measures :

1. Change in Frequency of Hot Flushes From Baseline (Day -1) at Days 7, 14 as Assessed by Skin Conductance [ Time Frame: Baseline (day -1) and days 7, 14 ]

   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.

2. 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 [ Time Frame: Baseline (week -1) and Week 1 ,Week 2 ]
   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.
3. Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Severity of Hot Flushes as Measured by Twice Daily Paper Diary [ Time Frame: Baseline (week -1) and weeks 1, Week 2 ]
   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.
4. Change From Baseline (Week -1) at Weeks 1, 2 in Average Daily Hot Flushes Severity Score as Measured by Twice Daily Paper Diary. [ Time Frame: Baseline (week -1) and week 1 , 2 ]
   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.
5. Change in Frequency From Baseline (Day -1), at Days 7, 14 of Hot Flushes as Measured by Continuous Day Time Diary. [ Time Frame: Baseline(day -1) and Day 7, 14 ]
   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.
6. Change From Baseline (Week -1) at Weeks 1, 2 in Night-time Awakenings (NTA) Secondary to Hot Flushes as Measured by Paper Diary [ Time Frame: Baseline (week-1) and weeks 1 , 2 ]
   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.
7. Change From Baseline (Day-1) to Day 1 and Day 7 in Luteinizing Hormone (AUC0-8) [ Time Frame: 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) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Post-menopausal female subjects experiencing frequent moderate to severe hot flashes.Menopause will be defined as:

  • 12 months of spontaneous amenorrhea;
  • OR at least 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy.

Exclusion Criteria:

• BMI > 35kg/m2.
• Any active comorbid disease, ECG or laboratory result deemed by the investigator to be clinically significant and which could impact safety during study conduct or that could interfere with the study evaluation, procedures or completion.
• Use of prohibited medications defined in the protocol.
• Inability or unwillingness to comply with study procedures or requirements.

Contacts and Locations

Locations

United States, Florida

Avail Clinical Research

DeLand, Florida, United States, 32720

QPS/MRA (Miami Clinical Research)

Miami, Florida, United States, 33143

United States, Texas

ICON Clinical Research Unit

San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Bayer

Nerre Therapeutics Ltd.

  Study Documents (Full-Text)

Documents provided by Bayer:

Study Protocol  [PDF] December 13, 2016

Statistical Analysis Plan  [PDF] May 5, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02865538
• Other Study ID Numbers: 21681
• First Posted: August 12, 2016
• Results First Posted: February 16, 2021
• Last Update Posted: February 16, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Hot flashes; Post-menopausal