NCT00785317Unknown4 期
Effects of Oral 1 mg Oestradiol (E2)/ 2 mg of Drospirenone (DRSP) Compared to Oral 1 mg of Oestradiol (E2)/ 0.5 mg Noresthisterone Acetate (NETA)on the Postmenopausal Breast; a Double Blind Randomized Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mammographic breast density - classified according to digitized data-based quantification of breast density.
研究概览
简要总结
The purpose of this study is to evaluate the effects on breast in postmenopausal women randomized to either oestradiol in combination with DRSP or E2 in combination with NETA during six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Naturally postmenopausal, symptomatic, apparently healthy women, with the need for hormone therapy aged 50 - 70 years with a BMI >18 and ≤30 kg/m2 and without any previous history of breast disease will be recruited for the study.
- •They should be amenorrheic for at least 12 months or less than 12 months with S- FSH values >40 IU/L.
- •They should be free of any sex hormone treatment for at least three months before inclusion.
排除标准
- •General contraindications for HT according to Swedish product label. Age >60 years. BMI ≤18 or ≥30 kg/m
- •Any previous history of cancer.
- •Any previous history of breast disease or abnormal mammogram.
- •In addition: hypertension (systolic BP >160 mm Hg or diastolic >100 mm Hg), hyperlipidemia (total cholesterol >8.0 mmol/L or triglycerides >3.0 mmol/L), diabetes mellitus, history of thromboembolic disease, heart failure, liver disease or porphyria, undiagnosed vaginal bleeding. No sex hormone treatment for at least three months before inclusion.
- •No concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.
研究组 & 干预措施
Angemin
Experimental
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP
干预措施: Angemin vs Activelle (Drug)
Activelle
Active Comparator
1 mg of oral E2 in continuous combination with 0.5 mg of NETA
干预措施: Angemin vs Activelle (Drug)
结局指标
主要结局
Mammographic breast density - classified according to digitized data-based quantification of breast density.
时间窗: 6 months
次要结局
- Effects on serum levels of Oestradiol etc.(6 months)
研究者
研究点 (1)
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