Comparison of the effectiveness of depo-medroxyprogesterone (DMPA)+Atorvastatin (combination) Vs DMPA in the treatment of adenomyosis
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the change in pain as measured by Wong Bakers FACES pain rating scale in patients receiving DMPA + Atorvastatin and DMPA alone
研究概览
简要总结
This is a study about comparing 2 drugs in the treatment of adenomyosis. The standard drug is compared with the test drug. Here, the standard drug is DMPA, i.e., DEPO MEDROXY PROGESTRONE, and the test drug is DMPA + ATORVASTATIN (Combination) where the DMPA concentrate on the AUB and ATORVASTATIN helps in reducing the pain and vascularity of the tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •patients diagnosed with adenomyosis in ultrasonography patients willing to participate patient willing to be on contraceptives during study period.
排除标准
- •patients planning for pregnancy pregnant and lactating patients patients with mental illness patients who are already in any other hormonal treatment for adenomyosis patients who have undergone surgery (less than 6 months) patients diagnosed with mild hepatic dysfunction.
结局指标
主要结局
To assess the change in pain as measured by Wong Bakers FACES pain rating scale in patients receiving DMPA + Atorvastatin and DMPA alone
时间窗: Patients will be followed at the end of 4, 8 and 12 weeks
To assess the change in abnormal uterine bleeding as measured by the UFS-QOL questionnaire in patients receiving DMPA + Atorvastatin and DMPA alone
时间窗: Patients will be followed at the end of 4, 8 and 12 weeks
次要结局
- To assess the change in uterine volume and vascularity by measuring the pulsatility index by transvaginal USG (MUSA criteria)
研究者
Maitrayee sen
SRM Institution