Comparison of effect of metformin with watchful observation in the treatment of breast lump

Efficacy and Safety of Metformin compared to Watchful observation in Breast fibroadenoma- A randomized, controlled, assessor-blinded study from India - NILL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072768

Enrollment

216

Registered

2024-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N602- Fibroadenosis of breast

Interventions

Intervention1: Metformin: 1000 mg SR, BD, Oral for 24 weeks Control Intervention1: Watchful observation: For 24 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed cases of breast fibroadenoma with lump size less than4cm. 2. Not willing to undergo surgical interventions. 3. Pre-menopausal women aged 18 to 50 years old with one or more, unilateral or bilateral fibroadenoma. 4. Willing to participate and give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Lump size greater or equal than 4cm. 2. Pregnancy and breastfeeding. 3. Vegetarianism. 4. Body mass index (BMI) more than 29.9. 5. History of breast cancer. 6. Allergy to biguanides. 7. Present diabetes mellitus. 8. Metabolic syndrome. 9. Renal dysfunction and hepatic dysfunction. 10. 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. 11. Irregular use of the medication or complete non-compliance.

Design outcomes

Primary

Measure	Time frame
1. Percentage of patients with complete absence of any detectable mass (Regression rate). 2. Change in average size (both increment or decrement) and average number of lesions from baseline.Timepoint: At 12 and 24 weeks.	—

Secondary

Measure	Time frame
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. 3. Change in BMI from baseline in overweight patients (BMI: 25-29.9) at each visit. Timepoint: At weeks 1, 4, 8, 12, and 24.	—

Countries

India

Contacts

Public ContactKeshav Kumar

Indira Gandhi Institute of Medical Sciences

misrahitesh75@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026