Medroxyprogesterone Acetate (MPA) Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Pathological complete response (CR) rates
研究概览
简要总结
To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia.
详细描述
Patients pathologically diagnosed with nonatypical simple or complex EH will be enrolled. Exclusion criteria include malignancy, liver disease or liver tumor (benign or malignant), kidney disease or kidney tumor (benign or malignant), any contradictions against progesterone, history of endometrial atypical hyperplasia or endometrial cancer, any progesterone-dependent tumors, ask for other treatment.
A detailed history including menstruation, fertility, other diseases and family history will be collected. Basic information including age, waist circumstances, hip circumstances and blood pressure will also be collected. Blood tests including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids, liver and kidney functions will be performed before taking progesterone orally.
All enrolled and consent informed patients will be randomized into two groups, A and B, using computer-generated random numbers. Patients in group A will orally take MPA (Medroxyprogesterone Acetate) (angonghuangtitong, Xianju pharmaceuticals, China)10mg daily from tenth day of menstruation for 15 days for 3-6months. While patients in group B will take dydrogesterone (duphaston; Abbott Healthcare Products B.V, the Netherlands) 10 mg, 2 tablets twice daily from fifth day of menstruation for 20 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium.
Complete response (CR) is defined as the reversion of EH to proliferative or secretory endometrium; partial response (PR) is defined as regression to disordered proliferative endometrium (DPE) or simple hyperplasia without atypic (only for complex hyperplasia); no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the progression of endometrial lesions.
Another 3-month therapy will be continued if the patients get NR. The longest treatment periods will be 6 months. If the patient gets PD or NR after 6 months therapy, new options must be put.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of endometrial hyperplasia without atypia;
- •Consent informed and signed;
- •Able to follow treatment and take therapy in Obstetrics and Gynecology of Fudan University
排除标准
- •Liver disease or liver tumor (benign or malignant)
- •Kidney disease or kidney tumor (benign or malignant)
- •Other malignancies in reproductive organs
- •Breast cancer or other progesterone-dependent tumors
- •History of endometrial atypical hyperplasia or endometrial cancer
- •Any contradictions against progesterone
- •Under treatment of progestin therapy or oral conceptive drugs one month before enrollment.
- •Pregnancy or suspicion of pregnancy
- •Ask for other treatment
研究组 & 干预措施
dydrogesterone
EH patients will take dydrogesterone 10 mg, 2 tablets twice daily from tenth day of menstruation for 15 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3-month to examine the endometrium. All of the findings will be recorded.
干预措施: Dydrogesterone 10 MG (Drug)
Medroxyprogesterone Acetate
EH patients will take MPA (Medroxyprogesterone Acetate) 10mg daily from tenth day of menstruation for 15 days for 3months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium. All of the findings will be recorded.
干预措施: Medroxyprogesterone Acetate (Drug)
结局指标
主要结局
Pathological complete response (CR) rates
时间窗: From date of randomization until the date of CR, assessed up to 6 months
The CR rates will be calculated after 3 and 6-month therapy based on the following formula: (Number of participants who got CR)/(All enrolled participants). The CR rates will be compared between two therapies (MPA VS dydrogesterone), also between two lesions (SH VS CH).
次要结局
- Rate of pregnancy(up to 2 years after the treatment for each patient)
- Compliance(up to 2 years after the treatment for each patient)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 2 years after the treatment for each patient)
- Median time of pathological complete response (CR)(From date of randomization until the date of CR, assessed up to 6 months)
- Relapse rates(up to 2 years after the treatment for each patient)
- cost(From date of randomization until the date of CR, assessed up to 6 months)
研究者
Xiaojun Chen
Principal Investigator
Fudan University