Clinical Trial Search

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: Hot Flash Related Daily Interference Scale (HFRDIS) Score — 4; 9 score on a scale

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

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 Average Frequency of Awakenings Due to Sleep-time Hot Flashes — -19.54; -20.55; -15.99 Awakenings

Primary: Hot Flashes — 10.3; 7.944 scores on a scale

Primary: Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) — -40.6; -35.1; -33.6; -38.9 weekly hot flushes — p=<0.001

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

Primary: Change in Depressive Symptoms as Indicated by The Center for Epidemiologic Studies Depression Scale (CES-D) — 1.04; -1.02 units on a scale

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: 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: Tolerability of Gabapentin — 22; 4 Participants

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

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: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 — -23.7; -1.9 percentage of cells — p=<0.0001

Primary: Mean IDAS Ill Temper Scale Score Over Time — 6.19; 6.02 score on a scale — p=0.09

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: Number of Women Who Visited Hospitals for Menopausal Symptoms Distributed Per Year — 786616; 787425; 791890; 818749 Participants

Primary: Center for Epidemiologic Studies-Depression Scale (CES-D) — 27.4; 29.1; 28.8; 24.6 Units on a scale

Primary: Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks — -2; -2; -1 change in units on a scale — p=0.08

Primary: Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans — .14; .13; .05; .13 percent BOLD signal…

Primary: Co-Primary Efficacy Endpoint - Vaginal Superficial Cells — 17.50; 16.72; 23.20; 5.63 percentage of vaginal superficial cells — p=< 0.0001

Primary: Change From Baseline in Menopause Rating Scale Total Score — 6.3; 4.5 units on a scale — p=0.05

Primary: Effect of Aging on Estrogen Negative Feedback on LH — -52.8; -53.2 % change from baseline — p=0.90

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: Hot Flash Diary — 9 number of hot flashes per week

Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5) — -22.8 units on a scale

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: Change From Baseline in Bone Mineral Density — 1.146; 1.132 g/cm2