A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 33
- 主要终点
- Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day
研究概览
简要总结
Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
详细描述
Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal women,
- •Ages 35 or older,
- •Frequent moderate to severe hot flushes,
- •Qualifying general medical health
排除标准
- •Disqualifying gynecological disorders,
- •Disqualifying dermatological disorders,
- •Disqualifying concurrent conditions
研究组 & 干预措施
Placebo transdermal three 90 μL sprays
Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
干预措施: Placebo transdermal three 90 μL sprays (Drug)
Placebo transdermal two 90 μL sprays
Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
干预措施: Placebo transdermal two 90 μL sprays (Drug)
Placebo transdermal one 90 μL spray
Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
干预措施: Placebo transdermal one 90 μL spray (Drug)
Estradiol transdermal three 90 μL sprays
Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
干预措施: Estradiol transdermal three 90 μL sprays (Drug)
Estradiol transdermal two 90 μL sprays
Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
干预措施: Estradiol transdermal spray, two 90 μL sprays (Drug)
Estradiol transdermal one 90 μL spray
Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
干预措施: Estradiol transdermal one 90 μL spray (Drug)
结局指标
主要结局
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day
时间窗: baseline to week 12
Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms \[hot flushes and sweating\] experienced each day. Mild, moderate and severe hot flushes and sweating were defined as follows: Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity
Mean Change the Severity of Moderate to Severe Vasomotor Symptoms
时间窗: baseline to week 12 (12 weeks)
Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day. Mild, moderate and severe were defined as follows: Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3.
次要结局
未报告次要终点