A Phase 2, Exploratory, Eight-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
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 10
- 主要终点
- Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8
研究概览
简要总结
This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (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
详细描述
Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 41 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
- •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
排除标准
- •History of hypersensitivity or adverse reaction to paroxetine mesylate
- •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)
Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
干预措施: Brisdelle (paroxetine mesylate) (Drug)
Placebo - Sugar Pill
Eligible subjects will be randomized to receive a sugar pill.
干预措施: Sugar pill (Drug)
结局指标
主要结局
Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8
时间窗: Week 4 and Week 8
The number of hot flashes reported in the result table are: * 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 8. They are both measured as hot flashes per week.
Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8
时间窗: Week 4 and Week 8
A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity. SS = (2•Fm + 3•Fs) ÷ (Fm + Fs) Where: SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score.
次要结局
- Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8(Week 4 and Week 8)
- Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4(Week 4)
- Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8(Week 4 and Week 8)
- Change From Baseline in Climacteric Symptoms at Week 8(Week 8)
- Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8(Week 8)
- Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8(Week 4 and Week 8)
- Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4(Week 4)
- Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8(Week 4 and Week 8)
- Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8(Week 8)