NCT00160316已完成3 期
Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study
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
- 454
- 试验地点
- 22
- 主要终点
- Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
研究概览
简要总结
The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Amenorrhoea for >= 12 months.
- •Serum estradiol and FSH level within the postmenopausal range
- •Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness < 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium
排除标准
- •Previous systemic unopposed estrogen replacement therapy over 6 months or more.
- •Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy.
- •History or presence of an estrogen dependent neoplasia (including breast- cancer).
- •History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin.
研究组 & 干预措施
1
Experimental
干预措施: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone (Drug)
结局指标
主要结局
Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
时间窗: 52 weeks
次要结局
- 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 (domains: psychological, vasomotor, somatic, sexual, menstrual, androgenic): average score of the single items within the domain; QualiPause Inventory 7D: weighted sum score of the symptoms(52 weeks)
研究者
研究点 (22)
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