Phase 2
N=199
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms
Menopause · Hot Flashes · Night Waking
Bottom Line
View on ClinicalTrials.gov: NCT03596762 ↗Enrolled (actual)
199
Serious AEs
2.5%
Results posted
Mar 2023
Primary outcome: Primary: Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 — 11.82; 12.13; 14.55; 13.54 Hot flushes per day — p== 0.1946
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Elinzanetant (BAY3427080) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 |
11.82; 12.13; 14.55; 13.54; 12.92; -2.45 | = 0.1946 |
| PRIMARY Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 |
11.82; 12.13; 14.55; 13.54; 12.92; -4.49 | = 0.2097 |
| PRIMARY Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 |
2.54; 2.51; 2.63; 2.54; 2.54; -0.31 | = 0.7033 |
| PRIMARY Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 |
2.54; 2.51; 2.63; 2.54; 2.54; -0.41 | = 0.5511 |
| SECONDARY Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 |
11.82; 12.13; 14.55; 13.54; 12.92; -1.22 | — |
| SECONDARY Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 |
2.54; 2.51; 2.63; 2.54; 2.55; -0.24 | — |
| SECONDARY Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 |
14.04; 14.19; 16.55; 15.39; 15.78; -1.36 | — |
| SECONDARY Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 |
2.34; 2.34; 2.46; 2.38; 2.35; -0.04 | — |
| SECONDARY Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 |
32.35; 32.84; 40.76; 36.59; 35.73; -3.09 | — |
| SECONDARY Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 |
17; 20; 5; 32; 30; 27 | — |
| SECONDARY Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 |
3.86; 3.44; 5.00; 3.80; 3.85; -0.65 | — |
| SECONDARY Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 |
2.90; 2.41; 4.05; 2.76; 2.57; -0.57 | — |
| SECONDARY Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 |
10.80; 11.94; 11.35; 10.80; 11.44; -0.63 | — |
| SECONDARY Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 |
12.43; 13.23; 13.24; 12.63; 13.74; -1.60 | — |
| SECONDARY Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 |
52.93; 52.74; 50.29; 53.86; 55.36; -4.00 | — |
| SECONDARY Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 |
4.00; 4.38; 4.47; 4.17; 4.50; -0.33 | — |
| SECONDARY Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 |
11.18; 14.29; 10.47; 9.92; 11.48; -1.90 | — |
| SECONDARY Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 |
64.254; 157.207; 292.929; 319.552; 78.946; 118.554 | — |
| SECONDARY Nature and Severity of Adverse Events |
28; 17; 14; 34; 38; 7 | — |
| SECONDARY Withdrawals Due to an Adverse Event |
1; 0; 2; 0; 5; 1 | — |
| SECONDARY Number of Subjects Used Concomitant Medications |
18; 8; 9; 12; 16; 14 | — |
| SECONDARY Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 |
123.2; 124.2; 128.9; 124.6; 124.0; 0.3 | — |
| SECONDARY Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 |
80.1; 78.7; 79.9; 78.1; 78.7; -0.7 | — |
| SECONDARY Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 |
69.7; 71.4; 70.6; 70.1; 69.7; -0.1 | — |
| SECONDARY Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 |
36.69; 36.62; 36.73; 36.52; 36.68; -0.09 | — |
| SECONDARY Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 |
75.85; 72.65; 78.14; 72.36; 74.11; 0.20 | — |
| SECONDARY Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 |
28.59; 27.69; 29.81; 27.26; 27.72; 0.07 | — |
| SECONDARY Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 |
95.47; 93.61; 97.59; 91.12; 92.42; 0.26 | — |
| SECONDARY Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit |
38; 24; 11; 31; 34; 33 | — |
| SECONDARY Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit |
9; 7; 6; 21; 18; 11 | — |
| SECONDARY Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) |
913.5; 891.4; 934.3; 927.8; 935.9; 17.3 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) |
162.6; 167.8; 162.9; 157.2; 164.2; 1.2 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) |
394.5; 397.2; 403.5; 402.3; 401.2; 3.6 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) |
410.6; 417.9; 416.4; 415.9; 415.2; 1.6 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) |
407.2; 413.8; 413.2; 413.1; 411.4; 1.2 | — |
| SECONDARY Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec |
0; 0; 0; 0; 0; 46 | — |
| SECONDARY Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec |
3; 0; 0; 0; 1; 19 | — |
| SECONDARY Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 |
34; 14; 13; 38; 38; 1 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes |
4.568; 4.537; 4.510; 4.516; 4.563; -0.106 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit |
0.4230; 0.4184; 0.4102; 0.4088; 0.4182; -0.0121 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin |
138.4; 137.3; 136.4; 134.6; 135.6; -3.0 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume |
92.74; 92.39; 90.92; 90.82; 91.88; -0.56 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils |
6.09; 6.17; 6.32; 6.31; 6.40; -0.19 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils |
0.61; 0.72; 0.59; 0.69; 0.59; 0.02 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride |
141.3; 141.6; 141.6; 141.2; 141.3; -0.1 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin |
68.8; 68.5; 68.1; 71.4; 70.1; 0.8 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase |
102.5; 91.6; 104.2; 161.8; 139.8; 28.2 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin |
67.4; 67.5; 66.5; 67.7; 67.0; -1.7 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C |
39.22; 39.05; 35.84; 38.78; 40.88; -0.42 | — |
| SECONDARY Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide |
12.17; 13.01; 13.94; 13.37; 13.36; 0.48 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH |
6.00; 6.10; 6.09; 6.21; 6.08; 0.10 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity |
1.0167; 1.0167; 1.0166; 1.0154; 1.0171; -0.0002 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite |
46; 30; 17; 49; 48; 1 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes |
1.3; 0.8; 2.0; 1.5; 0.6; -0.6 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts |
1.9; 0.8; 0.1; 0.8; 1.7; -1.1 | — |
| SECONDARY Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals |
4; 4; 2; 9; 7; 4 | — |
Summary
The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.
Eligibility Criteria
Key Inclusion Criteria
- Postmenopausal
- Body mass index between 18 and 38 kg/m2, inclusive
- Subject experiences moderate or severe hot flashes
Key Exclusion Criteria
- Inability to comply with the use of prohibited and allowed medications as described in the protocol.
- Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.
- Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
- Any clinically significant abnormal laboratory test result(s) measured at Screening.
- Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.
- Uncontrolled hypertension.
- A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.
Data sourced from ClinicalTrials.gov (NCT03596762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.