N/A N=32 Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
Menopause · Hot Flashes · Vasomotor Disturbance
Primary: Tolerability of Gabapentin — 22; 4 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=141 Flushing Reduction Associated With Nitrates
Menopausal Hot Flashes
Primary: Change From Baseline Hot Flash Frequency — -4.56; -4.02 Hot flashes per day — p=0.34
Phase 3 N=943 Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
Menopause · Vasomotor Symptoms
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
Phase 3 N=189 Progesterone for Perimenopausal Night Sweats
Hot Flushes · Night Sweats
Primary: Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks — 5.5; 7.1 Units of Vasomotor Symptom Score
Phase 4 N=157 Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Nocturnal Vasomotor Symptoms
Primary: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes — -19.54; -20.55; -15.99 Awakenings
N/A N=24 Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Vasomotor Rhinitis
Primary: Net Proportional Change in Nasal Airway Resistance — 0.11; 0.04 proportional change (unit-less)
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
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
N/A N=30 Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses
Nocturia · Hypertension · Sleep Disturbance
Primary: Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention — -0.4; 7.3; 3.9 percentage of daytime mean SBP — p=0.65
Phase 3 N=352 Study Of Adults And Adolescents With Vasomotor Rhinitis
Rhinitis, Vasomotor
Primary: Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) — -1.71; -2.05 Score on scale — p=0.050
Phase 2 N=356 A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
Menopause · Hot Flashes
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…
Phase 3 N=945 Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
Postmenopausal Symptoms · Menopause · Vasomotor Symptoms
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
Phase 2 N=374 MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
Menopause Hot Flashes
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
Phase 3 N=493 The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
Vasomotor Symptoms
Primary: Number of Participants With Nausea During the First 2 Weeks of Treatment — 24; 31; 28; 43 Participants — p=0.024
Phase 4 N=60 Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Insomnia
Primary: Within-person Change in ISI Score — -8.1; -5.6 score on a scale
Phase 2 N=37 Neuropeptide Treatment for Hot Flushes During the Menopause
Menopausal Flushing
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
N/A N=138 Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
Nocturia Associated With Nocturnal Polyuria
Primary: Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 — -2.01 Number of nocturnal voids
Phase 2 N=102 Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Hot Flashes
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
Phase 3 N=735 Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
Vasomotor Symptoms · Hot Flashes
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
Phase 2 N=65 Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon
Raynaud's Phenomenon Secondary to Connective Tissue Disease
Primary: Raynaud's Symptom Severity (Change From Baseline) — -20.19; -18.63 score on a scale
Phase 3 N=347 Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
Vasomotor Rhinitis · Rhinitis, Vasomotor
Primary: Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) — -2.11; -2.01 Score on a scale — p=0.604
N/A N=36 Vilazodone for Menopausal Hot Flashes
Hot Flushes
Primary: Daily Diary Ratings of Frequency of Hot Flashes — 3.65; 4.71 number of hot flashes — p=0.05
Phase 2 N=76 Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms
Post-menopausal Vasomotor Symptoms
Primary: Maximum Observed Plasma Concentration (Cmax) of BAY3427080 — 502.62; 731.69; 911.48; 1576.01 ng/mL
Phase 2 N=49 Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
Post-menopausal Vasomotor Symptoms
Primary: Peak Plasma Concentration (Cmax) of ACER-801 — 10.78; 32.36; 41.75 ng/mL
Phase 4 N=29 Impact of Hot Flashes on Sleep and Mood Disturbance
Menopause · Depression · Hot Flashes
Primary: Percent Change in Wake After Sleep Onset (WASO) — 62 percent change — p=0.007
Phase 2 N=169 Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients
Menopause
Primary: Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period) — 73.5; 69.5; 70.4; 67.9 Number of MSVS/2 weeks — p=0.5730
Phase 3 N=1,015 Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
Vasomotor Symptoms · Menopausal Symptoms
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…
N/A N=56 Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
Sleep Fragmentation · Poor Quality Sleep · Nocturia
Primary: Change in Nocturnal Polyuria Index — 41.7; 41.7; 34.5; 37.8 percentage of urine volume — p=0.3
Phase 3 N=454 Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Hot Flashes
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
N/A N=154 Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Menopause
Primary: Diary Based Sleepiness — 5.01; 5.13; 4.87; 4.72 score on a scale
Phase 3 N=150 Oxybutynin Chloride in Managing Hot Flashes
Breast Carcinoma · Ductal Breast Carcinoma In Situ · Hot Flashes
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…