Comparative Study Of Effect Of Atorvastatin With Mifepristone Versus Mifepristone In Medical Management Of Fibroid.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To assess the effect of atorvastatin with mifepristone and mifepristone alone on the size of leiomyoma,endometrial thickness and pattern,dysmenorrhea,heavy menstrual bleeding and quality of life
研究概览
简要总结
This study aims on the effectiveness of Atorvastatin with Mifepristone and mifepristone alone on the size of fibroid,endometrial thickness and pattern, dysmenorrhea,heavy menstrual bleed and quality of life. This study also aims on comparing the effectiveness of Atorvastatin with Mifepristone and mifepristone alone in medical management of fibroid and to note any side effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients in reproductive and perimenopausal age group with uterine fibroid having symptom.patients giving written informed consent.Patients who donot want surgery.
排除标准
- •Patients with severe presentation of fibroid such as severe intauterine bleeding or severe dysmenorrhea.Associated uterine and adnexal pathology like ovarian,cervical or uterine malignancy and associated medical morbidity like presence of liver disease,renal disease,myopathy,pancreatitis,hypersensitivity reaction and diabetes mellitus.patient necessitating early surgical intervention for uterine leiomyoma.Hormonal contraception or any hormonal therapy in the previous three months.Post menopausal women.Not willing to participate.
结局指标
主要结局
To assess the effect of atorvastatin with mifepristone and mifepristone alone on the size of leiomyoma,endometrial thickness and pattern,dysmenorrhea,heavy menstrual bleeding and quality of life
时间窗: The following parameters are recorded at the start of the study and at the completion of three months. | USG(TVS/WA) | VAS | PBAC | QOL
次要结局
- To compare the effectiveness of Atorvastatin with Mifepristone and mifepristone alone in medical management of fibroid(The following parameters are recorded at the start of the study and at the completion of three months.)
研究者
Dr Riya Goyal
Teerthanker Mahaveer Medical college and Research Centre, Moradabad