EUCTR2016-000410-30-AT进行中（未招募）1 期
PREOPERATIVE LOCALLY APPLIED OESTROGEN IN POSTMENOPAUSAL WOMEN WITH PELVIC ORGAN PROLAPSE: CHANGES IN SUBJECTIVE AND OBJECTIVE OUTCOME: A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
Medical University of Vienna, Department of Obstetrics and Gynecology0 个研究点目标入组 120 人开始时间: 2016年10月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •Able to read, understand and sign informed consent
- •Able to apply a vaginal cream
- •Symptomatic pelvic organ prolapse
- •Planned and indicated for surgery
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Suspicion or history of breast cancer or other oestrogen responsive malignancies (endometrial cancer)
- •unexplained abnormal vaginal bleeding
- •history of deep vein thrombosis
- •inherited or acquired blood clotting disorders (eg, APC resistance, Antithrombin III deficiency)
- •transient ischaemic attack, myo- cardial infarction or ischaemic heart disease
- •Hypersensitivity to oestrogen
- •Unable to read and sign informed consent
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