Comparison of efficacy and safety of different dosages of mifepristone in women with symptomatic fibroids.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fibroid volume
研究概览
简要总结
•Uterine fibroids are the most common benign tumour reported to occur in about 70% women in their reproductive years and about 40% have symptoms severe enough to warrant therapy.
•Medical treatment is predominantly used for preoperative correction of anaemia, size reduction and symptom management.
•Mifepristone is a is a progesterone receptor modulator with primarily antagonistic properties.
•In various studies mifepristone has shown to decrease size of fibroid and uterus, improve anemia and fibroid-related symptoms.
The present study is planned with the following objectives:
•Primary objective: To compare the effect of 25 mg daily dose, with 50 mg biweekly mifepristone, on fibroid volume in women with symptomatic fibroids.
•Secondary objective : To compare and study the effect of both the dosages on :
-
Haemoglobin levels
-
Improvement in pattern of periods
-
Any side effects would be noted to study and compare the
safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Symptomatic fibroid cases, measuring at least 3 cm exhibiting heavy menstrual bleeding or dysmenorrhoea or pelvic pressure 2.Those giving consent 3.Accepting the use of non-hormonal contraceptive 4.Agreeing to endometrial biopsy if needed.
排除标准
- •1.currently planning pregnancy during study period 2.menopausal 3.currently breastfeeding 4.adnexal mass or endometriosis
- •coagulation dysfunction or bleeding tendencies 6.severe anemia <5 g% or needing blood transfusion 7.current or recent (within 3 months) use of oral / systemic corticosteroids or mifepristone 8.use within past 6 months of GnRH analogues 9.any contraindication to receive anti-progestins 10.any history or suspicion of breast cancer or other genital malignancy 11.laboratory findings that give any suspicion of blood, liver or renal dysfunction 12.those not giving consent.
结局指标
主要结局
Fibroid volume
时间窗: 1.Before starting mifepristone | 2.at end of 3 months
次要结局
- 1. Haemoglobin levels(2. Improvement in pattern of periods and symptoms caused by fibroids.)