NCT01123538Unknown4 期
Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression
University Hospital of North Norway1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Whole blood and white blood cells gene expression profiling after 3 months of HT treatment
研究概览
简要总结
The purpose of this study is to compare combined postmenopausal hormone therapy natural progesterone to the one containing synthetic progestagen (i.e. chlormadinone acetate) at the blood transcriptome level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women defined as:
- •45 years< age < 65 years
- •Amenorrhoeic for ≥ 1 year
- •Amenorrhoeic for < 1 year either without any withdrawal vaginal bleeding for 3 consecutive months in spite of a cyclic progestagen treatment and/or blood estradiol levels ≤ 20 pg/mL and blood FSH levels ≥ 40 UI/mL
- •Women with bilateral ovariectomy
- •Women suffering of at least 1 postmenopausal symptoms listed:
- •Hot flashes,
- •Memory and Concentration Problems,
- •Mood Swings,
- •Insomnia,
- •Urinary Incontinence,
- •Night sweating,
- •Join pains,
- •Asthenia.
- •No use of hormone therapy (HT)
- •Previous HT user:
- •HT use < 3 months - stop for 6 months
- •HT use <= 1 year - stop for > 12 months
- •If previous use of soya derivatives in dietary supplements: washout period = 3 months
- •Signed informed consent, after having received both oral- and written- information regarding the study goals, its risks and benefits and its constraints, including the 12 month follow-up. A delay should be respected between information and the signature of the written consent.
排除标准
- •Past HT users who have used treatment for more than 1 year
- •Hysterectomized women
- •Women without health insurance (only in French centre)
- •History of cardio-vascular accident either arterial or venous
- •Untreated high blood pressure
- •Liver disease
- •History of cancer except basal-cell skin cancer and colon cancer
- •Severe history of familial breast cancer defined as at least 2 women first degree- relatives with breast cancer diagnosis before 50 years
- •History of severe mastalgia
- •History of breast biopsy showing hyperplasia (with or without atypia)
- •Undiagnosed vaginal bleeding
- •Diagnosed endometrial hyperplasia
- •Auto-immune disease (e.g. lupus)
- •Women with kidney transplant
研究组 & 干预措施
Natural progesterone
Other
Combined menopausal treatment containing natural progesterone
干预措施: Progesterone (Drug)
Chlormadinone acetate
Active Comparator
Combined menopausal treatment containing chlormadinone acetate
干预措施: Chlormadinone acetate (Drug)
结局指标
主要结局
Whole blood and white blood cells gene expression profiling after 3 months of HT treatment
时间窗: 0 and 3 months after treatment
次要结局
- Quality of life, proteome, plasma haemostatic variable measurements(0,3,6 and 12 months)
- Whole blood and white blood cells gene expression profiling after 12 months of HT treatment(0 and 12 months after treatment)
研究者
研究点 (1)
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