The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- LDL-cholesterol
研究概览
简要总结
A prospective, open-label, randomized controlled clinical trial to compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy .
详细描述
This is a prospective, open-label, randomized controlled clinical trial compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy during window phase. 120 Healthy postmenopausal women with intact uterus seeking treatment for menopausal symptoms are enrolled in this study.Participants are randomized into three groups, the CEE 0.3 mg/micronized progesterone (MP) 100 mg group; CEE 0.625 mg/MP 100 mg group; CEE 0.625 mg/dydrogesterone 10 mg group,metabolic parameters,body composition,bone mineral density,breast cancer risk factors and life quality will be measure at baseline,one year and two year intervention.The investigators hypothesize there may be differences of these parameters measured among three groups after intervention.
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •40 and 60 years old;
- •natural amenorrhea for more than 6 months but less than 5 years;
- •suffered by menopause symptoms and seeking for treatment;
- •serum follicle-stimulating hormone levels >40 IU/L and serum estradiol <30 pg/ml.
排除标准
- •contraindications for menopausal hormone therapy;
- •complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer;
- •cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol;
- •alcohol or drug abuse within the last 3 months;
- •use of hormone therapy in the past 3months;
- •endometrial thickness more than 5mm even after progestin withdrawal;
- •abnormal cervical scraping smear;
- •allergic to any ingredient of the drugs;
- •participation in other clinical trials within the last 6 months.
研究组 & 干预措施
CEE 0.625 mg/MP 100mg
CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years
干预措施: CEE 0.625 mg/MP 100mg (Drug)
CEE 0.3 mg/MP 100mg
CEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years
干预措施: CEE 0.3 mg/MP 100mg (Drug)
CEE 0.625 mg/dydrogesterone 10mg
CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years
干预措施: CEE 0.625mg/dydrogesterone (Drug)
结局指标
主要结局
LDL-cholesterol
时间窗: 5 minutes
body fat mass percentage
时间窗: 5 minutes
DEXA method
breast mammography
时间窗: 5 minutes
次要结局
- glucose(5 minutes)
- Endometrial thickness(5 minutes)
- weight(5 minutes)
- serum creatinine(5 minutes)
- bone mineral density(5 minutes)
- Mini-mental State Examination score(5 minutes)
- HAD scale(5 minutes)
- modified Kupperman score(5 minutes)
- serum glutamic pyretic transaminase(5 minutes)
研究者
Aijun Sun
professor
Peking Union Medical College Hospital