EUCTR2006-006199-39-IT进行中（未招募）不适用
A double-blind, randomized, multi-center study to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation (0.5 mg 17β-estradiol [E2] / 0.25 mg drospirenone [DRSP]) and to compare the bleeding pattern of subjects treated with 0.5 mg E2 / 0.25 mg DRSP with the bleeding pattern of subjects treated with 1.0 mg E2 / 0.5 mg norethisterone acetate (NETA) when used for hormone therapy (HT) for 1 year in post-menopausal women - Angeliq low/low endometrial safety study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- SCHERING
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Postmenopausal women - Non-hysterectomized women - symptoms required HT in the opinion of the investigator - Endometrial biopsy at screening without evidence of endometrial hyperplasia or cancer. Women who have insufficient endometrial tissue for diagnosis may be included if a TVUS shows a double-walled endometrial thickness of < 5mm.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- no endometrial byopsy available - usual HT excl. criteria applied
研究者
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