Post-menopausal Vasomotor SymptomsPhase 1/2RELENT-1NCT02865538

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

A Phase 1/2 study testing BAY3427080 in people with Post-menopausal Vasomotor Symptoms, run by Bayer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 to 65 years, women only
Conditions the study is for: Post-menopausal Vasomotor Symptoms
What is being tested?: BAY3427080
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 3 sitesUnited States
Study dates: 1 Aug 2016to 28 Mar 2017
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Avail Clinical Research
DeLand, Florida, 32720
QPS/MRA (Miami Clinical Research)
Miami, Florida, 33143
ICON Clinical Research Unit
San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: Evaluation of the Pharmacokinetics and Safety of NT-814 in Post-Menopausal Women With Vasomotor Symptoms

Conditions: Post-menopausal Vasomotor Symptoms
Being tested: BAY3427080, Placebo (for BAY3427080)
Keywords: Hot flashes, Post-menopausal
Medical subject headings: Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAY3427080Drug
Also called NT-814
Placebo (for BAY3427080)Drug

Study groups in NCT02865538
Study group	Role	What they receive
BAY3427080 Placebo	Placebo comparator	Not described Receives: Drug: Placebo (for BAY3427080)
50mg BAY3427080	Experimental	Not described Receives: Drug: BAY3427080
100mg BAY3427080	Experimental	Not described Receives: Drug: BAY3427080
150mg BAY3427080	Experimental	Not described Receives: Drug: BAY3427080
300mg BAY3427080	Experimental	Not described Receives: Drug: BAY3427080

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and day 14
Change From Baseline at Day 14 in Vital Signs: Weight
Weight was measured just prior to dosing (approx. 30 mins).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On or after first drug administration up to end of study (Day 21)

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201628 Mar 2017

First posted12 Aug 2016 (estimated)
Study start1 Aug 2016
Primary completion28 Mar 2017
Study completion28 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Post-menopausal Vasomotor SymptomsStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02865538
Sponsor's protocol ID: 21681
Acronym: RELENT-1
Status last verified: Feb 2025
First submitted: 3 Aug 2016
Last updated: 7 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 32068688