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The effect of metformin with vitamin E in improving breast pain and fibroadenoma size

Comparing the effect of metformin with vitamin E in improving mastalgia and breast fibroadenoma size:(Randomized clinical trial)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191104045328N21
Enrollment
72
Registered
2024-05-13
Start date
2024-05-17
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Breast fibroadenoma. Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group: Metformin 1000 mg tablets (Osveh Pharmaceutical Company, Tehran, Iran) will be taken once a day for 24 weeks. Intervention 2: Intervention group: Vitamin E tablets

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of breast fibroadenoma, unilateral or bilateral fibroadenoma less than 3 cm in size Consent to participate in the study aged 18-45 Body mass index above 30

Exclusion criteria

Exclusion criteria: Suffering from metabolic and endocrinology diseases Presence of pregnancy and breastfeeding History of malignant breast masses Use of anti-diabetic, hypoglycemic and anti-fat drugs

Design outcomes

Primary

MeasureTime frame
Breast fibroadenoma size. Timepoint: before the start of the study, three months and six months after the start of treatment. Method of measurement: sonography.;Mastalgia. Timepoint: before the start of the study, three months and six months after the start of treatment. Method of measurement: Visual Analogue Scale of pain.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Reza Shojaei

Arak University of Medical Sciences

R.shojaei@arakmu.ac.ir+98 86 3222 2003

Outcome results

None listed

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