The Effect of Hormone Therapy on Serum Ischemia Modified Albumin Levels in Surgical Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Hormone therapy usage
研究概览
简要总结
Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has been considered as a 'protective factor'. However, the risk of cardiovascular disease in women increases rapidly after menopause and the declining levels of endogenous estrogen is thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT) decreases the severity and intensity of menopausal symptoms and improves women's quality of life. Until the last 10 years, based on the results of observational studies, postmenopausal HT may protect women against cardiovascular events and decrease the risk of coronary artery disease by 35-50%. However, recent randomized primary and secondary prevention trials did not support the cardioprotective effect of HT.
The aim of this study is to assess the effect of hormone therapy on serum ischemia modified albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were enrolled for this prospective study. The serum İMA levels were recorded before and after (3 months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).
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
- 是
入选标准
- •accepting consent to participate in the trial and signing the form
- •Surgical menopausal women aged 45-55 (having TAH + BSO for benign reasons)
- •Presence of vasomotor or menopausal symptoms (moderate to severe);
- •no systemic disease or infectious disease in the past 2 weeks
- •Not taking any other hormone therapy or medication until postoperative 6th week;
- •no contraindications for hormone therapy in routine menopause evaluation;
- •Willingness to take hormone therapy
- •No smoking.
排除标准
- •Any systemic disease presence
- •Contraindications for hormone therapy
- •Failure to follow-up
- •Inability to complete three months of hormone therapy
- •quitting hormone therapy for other medical reasons during hormone therapy
- •Cases reported as preinvasive and invasive genital tumors as a result of TAH + BSO
- •Cases reported as suspicious findings in the mammography report
结局指标
主要结局
Hormone therapy usage
时间窗: 12 months
Estradiol hemihydrate containing preparation 12 boxes in all patients given 1 tablet per day (2 mg / day) was prescribed as. Patients were recommended to reapply at the 3rd, 6th, and 12th months of treatment following drug use.
Measuring serum ischemia-modified albumin (IMA) level
时间窗: 12 months
After collecting all blood, serums were re-dissolved, and serum IMA levels were checked. IMA level was evaluated by the rapid colorimetric method developed by Barr-Or as an absorbance unit. For IMA, the results were recorded in the spectrophotometer at appropriate wavelengths, and the results were recorded as absorbance units.
次要结局
未报告次要终点
研究者
Suleyman Guven
professor
Karadeniz Technical University