A Double-Blind, Randomized, Placebo-Controlled Study Assessing The Safety And Efficacy Of DVS SR For The Treatment Of Vasomotor Symptoms Associated With Menopause
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,186
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy, postmenopausal women who seek treatment for hot flushes
- •Body Mass Index (BMI) less than or equal to 34 kg/m^2
排除标准
- •Hypersensitivity to Venlafaxine
- •Myocardial infarction an/or unstable angina within 6 months of screening
- •History of seizure disorder
研究组 & 干预措施
1
desvenlafaxine succinate (DVS) SR
干预措施: desvenlafaxine succinate (DVS) SR (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4
时间窗: Baseline and Week 4
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12
时间窗: Baseline and Week 12
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4
时间窗: Baseline and Week 4
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\*Number of mild+2\*Number of moderate+3\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12
时间窗: Baseline and Week 12
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\*Number of mild+2\*Number of moderate+3\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events
时间窗: Baseline up to Month 12
Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.
次要结局
- Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes(Baseline and Week 12)
- Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes(Baseline, Week 4 and Week 12)
- Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes(Baseline, Week 4 and Week 12)
- Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes(Week 12)
- Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12(Baseline, Month 6 and Month 12)
- Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12(Baseline and Week 12)
- Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6(Baseline and Month 6)
- Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12(Baseline and Month 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12(Week 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6(Month 6)
- Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12(Month 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12(Week 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6(Month 6)
- Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12(Month 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12(Week 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6(Month 6)
- Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12(Month 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12(Week 12)
- Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6(Month 6)
- Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12(Month 12)