Efficacy and Safety of Metformin compared to Watchful observation in Breast fibroadenoma- A randomized, controlled, assessor-blinded study from India
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- 1. Percentage of patients with complete absence of any detectable mass (Regression rate).
研究概览
简要总结
Ø This study is a randomized, assessor-blinded, parallel group single-centre trial assessing efficacy and safety of metformin 1000 mg SR twice daily compared with Watchful observation for 24 weeks. The primary objective is to assess change in number and size of breast lumps while the secondary objective is to assess safety/tolerability in patients, effect of metformin on glycemic status in pre-diabetics, and effect of metformin on weight in overweight patients of breast fibroadenoma receiving metformin. The primary outcome measures will be proportion of patients with complete absence of any detectable mass (regression rate) and change in average size (both increment or decrement) and average number of lumps from baseline to be assessed at week 12 and 24. Secondary outcome measures will be intolerability warranting dose reduction or drug withdrawal and any serious adverse effect; change in blood sugar level and HbA1c level from baseline in pre-diabetics; and change in body mass index from baseline in overweight patients (BMI: 25-29.9) at weeks 1, 4, 8, 12 and 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosed cases of breast fibroadenoma with lump size less than4cm.
- •Not willing to undergo surgical interventions.
- •Pre-menopausal women aged 18 to 50 years old with one or more, unilateral or bilateral fibroadenoma.
- •Willing to participate and give written informed consent.
排除标准
- •Lump size greater or equal than 4cm.
- •Pregnancy and breastfeeding.
- •Vegetarianism.
- •History of breast cancer.
- •Allergy to biguanides.
- •Present diabetes mellitus.
- •Metabolic syndrome.
- •Renal dysfunction and hepatic dysfunction.
- •Use of concomitant medications like oral contraceptives or any medicine containing estrogens or progestins or phytoestrogen containing medications, GnRH agonists and antagonists, clomiphene, tamoxifen, aromatase inhibitors, danazol, oral contraceptives or any medicine containing estrogens or progestins.
- •Irregular use of the medication or complete non-compliance.
结局指标
主要结局
1. Percentage of patients with complete absence of any detectable mass (Regression rate).
时间窗: At 12 and 24 weeks.
2. Change in average size (both increment or decrement) and average number of lesions from baseline.
时间窗: At 12 and 24 weeks.
次要结局
- 1. Intolerability warranting dose reduction or drug withdrawal and any serious adverse effect.(2.Change in blood sugar level and HbA1c level from base line in pre-diabetics at each visit.)
研究者
Keshav Kumar
Indira Gandhi Institute of Medical Sciences