Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Uterine fibroid size
研究概览
简要总结
Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. In the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.
详细描述
The proposal of the present study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo, simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months.
CBC, Lipid profile, kidney & Liver function tests, FBS & hormonal evaluation will be performed before and after the treatment. Ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 20-40 years
- •Intramural Fibroids confirmed by ultrasound
- •Presence of at least one fibroid with size >4 cm or two fibroids with size >3 cm detected by pelvic ultrasound.
- •Presence of at least 3 fibroids with size <3 cm and a history of 2 IVF failures.
- •Number of fibroids ≤ 5
- •BMI>25 Kg/m2
排除标准
- •Pregnancy
- •Hormonal contraception or any hormonal therapy received in the last 3 months
- •Alcohol consumption
- •Allergic to simvastatin
- •Suspicion or diagnosis of cancer
- •Signs or symptoms of mental illness, hepatic dysfunction, myopathic syndromes, diabetes mellitus, renal disease, Cardiovascular disease, hypothyroidism, hypotension, neuropathy, lupus and cataract
- •Taking antifungal medications, Lipid-Lowering medications (gemfibrozil, clofibrate), warfarin, danazol and erythromycin in the last one month.
- •Severe male factor
- •Severe endometriosis
- •Diminished ovarian reserve
研究组 & 干预措施
Simvastatin and vaginal placebo
The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months.
干预措施: oral drug and vaginal placebo (Drug)
Simvastatin and oral placebo
The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months.
干预措施: oral drug and oral placebo (Drug)
Vaginal placebo+ oral placebo
The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months.
干预措施: Vaginal placebo+ oral placebo (Drug)
结局指标
主要结局
Uterine fibroid size
时间窗: 3 months
Evaluation the size of Uterine fibroid withultrasound.
次要结局
- Plasma concentration of Vitamin D3(3 months)
- Uterine size(3months)