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临床试验/NCT04454775
NCT04454775已完成不适用

The Effect of Raloxifene on the Parameters of Coagulation System in the Postmenopausal Women

Karadeniz Technical University0 个研究点目标入组 80 人开始时间: 2005年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Measuring coagulation parametres

研究概览

简要总结

Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation parameters in healthy postmenopausal women.

Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical University Hospital at gynecology out-patient clinic from December 2005 to December 2006. Local institutional ethics committee approved our study protocol and written informed consent was obtained from all participants before enrollment. All patients received daily 600 milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor modulator (SERM), was added to treatment protocol if patients required hormonal therapy. Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the study group(n=50). Control group (n=30) was made up of the patients only receiving calcium and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and fibrinogen levels were measured in all patients before treatment. These measurements were repeated at three and twelve months after treatment. Comparisons were performed with Student t test or Mann Whitney test between the two groups and two-way ANOVA within the groups. Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p<0.05 was considered statistically significant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
42 Years 至 62 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • In the study planned on patients who have not had menstruation for at least one year, or who have been in menopause naturally or surgically,
  • the presence of menopause was accepted if the patients' FSH level was> 40 IU / L. Verbal and written consent was obtained from all patients included in the study.

排除标准

  • . Hypertension,
  • diabetes mellitus,
  • hypercholesterolemia,
  • presence of hepatic-renal-thyroid-parathyroid-adrenal diseases,
  • cardiovascular,
  • cerebrovascular and thromboembolic diseases,
  • undiagnosed vaginal bleeding,
  • presence of hormone-dependent malignancy or anamnesis,
  • presence of varicose veins,
  • chronic drug use that disrupts sex steroid metabolism
  • cases with smoking
  • alcohol use

结局指标

主要结局

Measuring coagulation parametres

时间窗: 1 year

After collecting all blood, Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III, and fibrinogen levels were measured in all patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suleyman Guven

professor

Karadeniz Technical University

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