A Phase 3, Twelve-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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 614
- 试验地点
- 71
- 主要终点
- Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.
研究概览
简要总结
The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.
详细描述
This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, ≥ 40 years of age at screening (inclusive)
- •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 to the screening visit
- •Spontaneous amenorrhea for at least 12 consecutive months or
- •Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
- •Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy
排除标准
- •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
研究组 & 干预措施
Brisdelle (paroxetine mesylate)
Brisdelle (paroxetine mesylate)
干预措施: Brisdelle (paroxetine mesylate) (Drug)
Placebo Capsules
Placebo Capsules
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.
时间窗: 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
时间窗: 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 The calculated severity score is reported below.
次要结局
- Change From Baseline in Total Number of Awakenings Due to Hot Flashes, 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(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)
- BMI Change From Baseline (kg/m2), Median(Week 4 and Week 12)
- Assessment of Mood(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)
- Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)(Week 4 and Week 12)
- Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%)(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 Patient Global Improvement (PGI) Scale Responders (%)(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)
- 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)
- Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression(Week 4 and Week 12)
- Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.(Week 4 and Week 12)