Clinical Trial Search

Primary: Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4 — -4.2; -6.1; -7.2; -7.0 VMS per…

Primary: Daily Diary Ratings of Frequency of Hot Flashes — 3.65; 4.71 number of hot flashes — p=0.05

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: Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo — -16.9; -10.6; -5.7 score…

Primary: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) and Number of Participants With Mild, Moderate and Severe AE — 54; 52; 45; 51 Participants

Primary: Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]). — 13.38; 14.26; -7.48; -4.37 Hot Flashes per day…

Primary: Percent Change in Frequency of Hot Flashes Over Time — -77.2; -51.8; -53.8; -67.0 Percent change from baseline

Primary: Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 4 — 12.1; 12.2; 12.6; 12.3 Events per day — p=<0.01

Primary: Mean Change in Frequency of Moderate to Severe Hot Flashes (HFs) From Baseline to Week 12 (Assessed by Hot Flash Daily Diary [HFDD]) — 6.71; 6.81; -5.40; -3.50 Number of…

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 Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment — -7.0; -6.9; -5.4 Hot flashes — p=0.0024

Primary: Hot Flash Frequency — 27.19; 68.26; 19.44; 62.32 hot flashes per week

Primary: Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4 — 5.3; 5.1; 5.8 number of hot flashes per day

Primary: Device Usage

Primary: G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period…

Primary: Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD) — 14.66; 16.16; -8.58; -6.07 Hot Flashes per day — p=< 0.0001

Primary: Total Number of Hot Flushes During the Final Week of Each 4 Weeks Treatment Period — 19.35; 49.01 hot flushes — p=<0.0001

Primary: Change From Baseline Hot Flash Frequency — -4.56; -4.02 Hot flashes per day — p=0.34

Primary: Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes — 0.35; 0.38 ratio — p=0.723

Primary: Peak Plasma Concentration (Cmax) of ACER-801 — 10.78; 32.36; 41.75 ng/mL

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 8 — 82.44; 83.18; 37.3; 28.5 Hot flashes — p=0.0177

Primary: Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value) — -54.515; -54.125; -44.389; -30.020 Hot Flushes per week — p=<0.0001

Primary: Hot Flash Frequency — 3.48; 3.95; 4.76 Hot flashes per 24 hr

Primary: Hot Flash Daily Diary — 88.7; 94.6; 41.3; 55.9 Hot Flash Score

Primary: Change From Baseline to Week 12 in The Weekly General Hot Flash Score — -12.19; -26.51 score on a scale — p=<0.001

Primary: Percent of Baseline in Average Hot Flash Activity (Score and Frequency) — 64.6; 67.4 Percent of baseline — p=0.0903

Primary: Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks — 5.5; 7.1 Units of Vasomotor Symptom Score

Primary: Percent Change in Wake After Sleep Onset (WASO) — 62 percent change — p=0.007

Primary: Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries — 9.88; 9.66 Hot flashes/day