A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Oral Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 735
- 主要终点
- Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
研究概览
简要总结
The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
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
- Double (Participant, Investigator)
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
- •Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week
排除标准
- •The usual exclusion criteria for hormone therapy apply
- •Intake of medications other than hormones affecting hot flushes
研究组 & 干预措施
Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
干预措施: Placebo (Drug)
0.5mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
干预措施: 0.5mg DRSP / 0.5mg E2 (BAY86-4891) (Drug)
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
干预措施: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) (Drug)
Estradiol (E2 0.3mg)
One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
干预措施: Estradiol (E2 0.3mg) (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
时间窗: Baseline until 12 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
时间窗: Baseline until 4 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
时间窗: Baseline until 12 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
时间窗: Baseline until 4 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.
次要结局
- Change From Baseline to Week 12 in Vaginal pH(Baseline until 12 weeks of treatment)
- Change From Baseline to Week 12 in Vaginal Maturation Value(Baseline until 12 weeks of treatment)
- Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'(After 12 weeks of treatment)
- Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'(After 12 weeks of treatment)
- Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'(After 12 weeks of treatment)
- Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'(After 12 weeks of treatment)
- Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'(After 12 weeks of treatment)
- Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'(After 12 weeks of treatment)
- Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'(After 12 weeks of treatment)
- Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'(After 12 weeks of treatment)