A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
研究概览
简要总结
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Naturally or surgically menopausal
- •Minimum 7 daily or 50 weekly moderate-to-severe hot flashes
排除标准
- •Any contraindication to hormone therapy
研究组 & 干预措施
1
0.3 mg SCE-B Daily
干预措施: SCE-B (Drug)
1
0.3 mg SCE-B Daily
干预措施: Placebo (Drug)
2
0.625 mg SCE-B Daily
干预措施: SCE-B (Drug)
2
0.625 mg SCE-B Daily
干预措施: Placebo (Drug)
3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
时间窗: Baseline to End of Treatment (Week 12)
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
次要结局
- Mean Change in Individual Sleep Parameters on a Three-point Scale(Baseline to End of Treatment (Week 12))
- Mean Change in Stanford Sleepiness Scale(Baseline to End of Treatment (Week 12))
- Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).(From baseline to End of Treatment (Week 12))
- Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)(Baseline to End of Treatment (Week 12))
- Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).(Baseline to End of Treatment (12 weeks))