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临床试验/EUCTR2007-005109-23-SE
EUCTR2007-005109-23-SE进行中(未招募)不适用

ow-Dose Hormone Therapy Initiated early after Menopause and Changes in Artery Wall Composition (AWC), as Assesssed by High-Frequency Ultrasound. - AWC LowE

ppsala University Hospital0 个研究点开始时间: 2009年6月30日最近更新:
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

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, i.e. > 1 year after last menstrual period
  • Age 50 - 59 years; Having an intact uterus; HRT naive or more than 3 yrs since last use of medium potent HRT (low-dose vaginal regimens allowed); Endometrial thickness <=5mm at inclusion. Normal mammogram within the last 12 months.
  • Signed informed consent.
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Current or previous use of HT within the last 3 years; current use of lipid-lowering agents, oral corticosteroids for more than one month within the last 3 years;Body Mass Index (BMI) >35 kg/m2;
  • Known or suspected past or present history of breast cancer;
  • Known, suspected or past estrogen dependent neoplasia, e.g. endometrial cancer;
  • Known, present or past history of coronary heart disease.
  • Contraindication for HT: undiagnosed genital bleeding, untreated endometrial hyperplasia, previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism), active or recent arterial thromboembolic disease ) e.g. angina, myocardial infarction), acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal, known hypersensitivity to the active substances or to any of the excipients, porphyria
  • Hypertension: >150/95
  • Untreated Thyroid disease.

研究者

发起方
ppsala University Hospital

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