跳至主要内容
临床试验/EUCTR2014-000179-18-GB
EUCTR2014-000179-18-GB进行中(未招募)1 期

ocal Oestrogen Treatment in Postmenopausal Women Undergoing Pelvic Organ Prolapse Surgery (LOTUS) - Feasibility Study - LOTUS

niversity of Birmingham0 个研究点目标入组 100 人开始时间: 2015年3月10日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
100

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

入选标准

  • 1.Postmenopausal women
  • 2.Consented to undergo surgical intervention for pelvic organ prolapse
  • 3.Have not received HRT in the last 12 months
  • 4.Willing to be randomised
  • 5.Give written informed consent
  • Are the trial subjects under 18?
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

排除标准

  • 1. Previous breast or uterine malignancy or other hormone- dependent neoplasms
  • 2. Genital bleeding of unknown origin
  • 3. Previous thrombo-embolic episodes in relation to oestrogen therapy
  • 4. Women who cannot understand speak or write in English
  • 5. Women known to be allergic to any of the components of vaginal oestrogens
  • 6. Two or more episodes of culture positive UTI in the last 6 months
  • 7. Previous POP surgery
  • 8. Voiding dysfunction(PVR>150ml)
  • 9. Current or previous POP surgery involving mesh

研究者

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