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临床试验/NCT04424173
NCT04424173已完成不适用

The Effect of Low Dose Combined Hormone Therapy (Estradiol And Norethindrone Acetate) on Serum CRP Levels and Life Quality in Natural Menopause Women

Karadeniz Technical University0 个研究点目标入组 45 人开始时间: 2007年8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
45
主要终点
Blood was drawn for basal CRP from all patients

研究概览

简要总结

This study aims to assess the effect of low dose combined estradiol and norethindrone acetate hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural menopause women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5 mg Norethindrone acetate).

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
45 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Accepting consent to participate in the research and signing the form;
  • Postmenopausal women 45-55 years old
  • not having had menstruation for the past 6 months;
  • Hormone results compatible with menopause (FSH> 20 milli-International unit(mIU) / mL, E2 <20 mIU / mL) and presence of vasomotor and/or menopausal symptoms (moderate to severe);
  • no systemic disease (Diabetes, hypertension, hyperlipidemia, ischemic heart disease), or no infectious disease in the past 2 weeks;
  • not taking any hormone therapy or medication for at least 2 months;
  • no contraindications for hormone therapy in routine menopause evaluation;
  • Willingness to take hormone therapy
  • No smoking.

排除标准

  • Any systemic disease (DM, HT, hyperlipidemia, ischemic heart disease) presence
  • Contraindications for hormone therapy
  • Failure to follow-up
  • Inability to complete three months of hormone therapy
  • Stopping hormone therapy due to vaginal bleeding during hormone therapy

结局指标

主要结局

Blood was drawn for basal CRP from all patients

时间窗: 12 months

The patients who were evaluated for the Blatt-Kupperman index and MENQOL questionnaire were given three months of treatment to the patient, which included 1.03 mg , Estradiol hemihydrate and 0.5 mg Norethindrone acetate

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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