IRCT20100706004329N7招募中3 期
Evaluation of the Effect of Metformin on Breast Fibroadenoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 206
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 50 years（—）
- 性别
- Female
入选标准
- •Aged between 18 and 50 years old
- •Unilateral or bilateral fibroadenoma of the breast smaller than 3 cm in size, detected by examination and ultrasound. (Diagnostic criteria: 1. in patients under the age of 40 years and patients with masses smaller than 2 cm, the diagnosis will be based on the typical examination and ultrasonographic scan. 2. in patients over 40 years with any size of the mass and patients with masses above 2 cm, the diagnosis will be based on a typical examination, ultrasonographic scan, and pathological investigation of the mass.
排除标准
- •Body mass index greater than 29.9 kg / m2
- •Use of hormonal medications (such as estrogen, progesterone, GnRH agonist, GnRH antagonist, clomiphene, tamoxifen, letrozole, danazol, contraceptive pills, progesterone IUDs, DHEA) and drugs that affect metabolic status, such as weight, glucose, and lipid-lowering agents
- •Regular consumption of nutritional, medicinal and herbal supplements (such as phytoestrogenic plant compounds, vitamin-rich foods, minerals such as zinc, calcium and ..., multivitamins, vitamins A, E, D, inositol, omega-3, 6)
- •Breast cancer or history of breast cancer
- •A family history of breast cancer in first-degree relatives
- •Hormonal disorders and metabolic diseases such as hypo or hyperthyroidism, metabolic syndrome, diabetes, severe hyperlipidemia - galactorrhea and the pituitary microadenoma
- •Proven or suspected pregnancy and lactation during the intervention
- •Other medical conditions, such as cardiovascular disease, epilepsy, renal or hepatic disorders
- •Contraindications for metformin use (such as hypersensitivity to biguanides, acidemia, heart disease, alcohol consumption, gastroparesis, hepatic disease, hyperthyroidism or hypothyroidism, severe iron deficiency anemia, renal impairments)
- •History of unwanted and intolerable side effects of metformin (such as abdominal pain, chest pain, chills, cholestasis, diarrhea, dizziness, increased liver enzymes, severe headache, hepatitis, hypoglycemia, megaloblastic anemia, myalgia, nausea, Palpitations, rash, rash, vomiting)
研究者
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