ACTRN12611000200987已完成4 期
Supplementation with alpha lipoic acid and hormone therapy with tibolone in menopausal transition: impact on oxidative stress, bone mass and quality of life.
niversidade Federal do Rio Grande do Norte0 个研究点目标入组 200 人开始时间: 2011年2月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 55 Years(—)
- 性别
- Female
入选标准
- •Menstrual irregularity and/ or less than 12 months amenorrhea;;
- •Scoring less than 14 points in the Menopausal Index Blatt and Kupperman;
- •Serum concentrations of FSH >30 IU/
排除标准
- •a)prior hormone therapy(HT) ; b) amenorrhea for more than 12 months c) early menopause(before age 40 years) or surgical menopause(hysterectomy or bilateral oophorectomy) d)the presence of systemic diseases (cardiovascular disease, diabetes, hypertension, cerebrovascular disease, thromboembolic disease, hepatic, or renal failure); e) the presence of osteoporosis; f) the presence of contraindications to HT (endometrial hyperplasia, malignant breast disease, endometrium cancer, undiagnosed vaginal bleeding); g) the presence of acute infection or chronic inflammatory disease; h)the use of drugs that could affect the metabolism (b-blockers, glucocorticoids, diuretics, lipid lowering drugs, antidiabetics, antiresorptives, anticoagulants); i) Smokers; j) the use of alcohol or drug abuse; l)Body Mass Index> 35 kg / m²; m)endometrial thickness on transvaginal ultrasound> 15 mm; n)Results of Cytopathology oncotic previous or current diagnoses of atypia of undetermined significance , high grade intraepithelial lesions, microinvasive carcinoma and cervical cancer; o)Presents some contraindication to therapy with tibolone; p) Medical conditions not listed but which may interfere with the climacteric; q) Fears, real or anticipated claims for treatment that might interfere with the objectives of the study; r)Simultaneous participation in another clinical trial.
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