A Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 570
- Locations
- 32
- Primary Endpoint
- Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.
Study Overview
Brief Summary
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
Detailed Description
The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows:
- Moderate VMS: Sensation of heat with sweating, able to continue activity
- Severe VMS: Sensation of heat with sweating, causing cessation of activity
The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female, >40 years of age
- •Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
- •Spontaneous amenorrhea for at least 12 consecutive months
- •Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
- •Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy
Exclusion Criteria
- •BMI ≥ 40 kg/m²
- •Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
- •History of self-injurious behavior
- •History of clinical diagnosis of depression; or treatment for depression
- •History of clinical diagnosis of borderline personality disorder
- •Use of an investigational study medication within 30 days prior to screening or during the study
- •Concurrent participation in another clinical trial or previous participation in this trial
- •Family of investigational-site staff
Arms & Interventions
Brisdelle (paroxetine mesylate)
Brisdelle (paroxetine mesylate)
Intervention: Brisdelle (paroxetine mesylate) (Drug)
Placebo capsules
Sugar pill
Intervention: Placebo capsules (Drug)
Outcomes
Primary Outcomes
Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.
Time Frame: Week 4 and Week 12
Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: * Mean Baseline frequency of moderate to severe VMS * Mean change in frequency of moderate to severe VMS from baseline to Week 4 * Mean change in frequency of moderate to severe VMS from baseline to Week 12
Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.
Time Frame: Week 4 and Week 12
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes
Secondary Outcomes
- Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.(Week 24)
- Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median(Week 4 and Week 12)
- Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)(Week 4 and Week 12)
- Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)(Week 4 and Week 12)
- Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.(Week 4 and Week 12)
- Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression(Week 4 and Week 12)
- Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median(Week 4 and Week 12)
- Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median(Week 4 and Week 12)
- Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median(Week 4 and Week 12)
- Percentage of Responders(Week 4 and Week 12)
- Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median(Week 4 and Week 12)
- Assessment of Mood(Week 4 and Week 12)
- BMI Change From Baseline (kg/m2), Median(Week 4 and Week 12)
- Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median(Week 4 and Week 12)
- Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median(Week 4 and Week 12)