Clinical Trial Search

Primary: Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4 — -3.9; -5.6; -6.0; -6.0 Number of events — p=<0.01

Primary: Tolerability of Gabapentin — 22; 4 Participants

Primary: Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression — -7.5 units on a scale

Primary: Montgomery-Asberg Depression Rating Scale (MADRS) — 26.2; 27.0; 15.7; 15.2 units on a scale — p=0.29

Primary: Number of Participants With Nausea During the First 2 Weeks of Treatment — 24; 31; 28; 43 Participants — p=0.024

Primary: Net Proportional Change in Nasal Airway Resistance — 0.11; 0.04 proportional change (unit-less)

Primary: Percentage of Subjects With Adverse Events — 56.7 percentage of subjects

Primary: Maximum Observed Plasma Concentration (Cmax) of BAY3427080 — 502.62; 731.69; 911.48; 1576.01 ng/mL

Primary: Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12. — 11.79; 11.65; -4.71; -3.36 Hot flash per day — p=<0.0001

Primary: Mean Change in Weekly Frequency of Moderate to Severe Vasomotor Symptoms (VMS) From Baseline to Week 4 and Week 12 -- (Efficacy Study Part) — -39.77; -40.11; -31.82…

Primary: Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 — -1.92; -2.75; -2.75; -1.39 VMS per day

Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12. — 10.83; 10.90; -4.13; -2.71 Hot flashes per day — p=<0.0001

Primary: Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day — -5.32; -6.19; -4.76; -8.44 Vasomotor symptoms per day — p=<0.0001

Primary: Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 — -6.52; -3.64 Hot Flushes — p=<0.001

Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8 — 82.44; 83.18; 37.3; 28.5 Hot flashes — p=0.0177