NCT00251082已完成3 期
A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 18
- 主要终点
- The change in the number of moderate to severe hot flushes from baseline to week 13
研究概览
简要总结
To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-hysterectomised postmenopausal women
- •Amenorrhoea for >= 12 months
- •Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range
排除标准
- •Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
- •Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).
- •Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness >= 5 mm (double layer) by transvaginal ultrasound.
- •The presence of an endometrial polyp at baseline.
- •Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).
- •Estradiol pellet/implant therapy during the past 6 months.
- •Previous systemic unopposed estrogen replacement therapy over 6 months or more.
- •History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin
研究组 & 干预措施
C
Placebo Comparator
干预措施: Placebo (Drug)
A
Experimental
干预措施: continuous combined estradiol and dydrogesterone (Drug)
B
Active Comparator
干预措施: continuous combined estradiol and dydrogesterone (Drug)
结局指标
主要结局
The change in the number of moderate to severe hot flushes from baseline to week 13
时间窗: 12 weeks
次要结局
- Change in the Menopause Rating Scale from baseline to weeks 4 and 13;(52 weeks)
- Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);(52 weeks)
- Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;(52 weeks)
- QualiPause Inventory 7D: weighted sum score of the symptoms(52 weeks)
- Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;(12 weeks)
研究者
研究点 (18)
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