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Effect of Metformin on Breast Fibroadenoma

Evaluation of the Effect of Metformin on Breast Fibroadenoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100706004329N7
Enrollment
206
Registered
2018-10-07
Start date
2018-09-23
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

fibroadenoma of breast. Benign neoplasm of breast

Interventions

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Menopause 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)

Design outcomes

Primary

MeasureTime frame
Size of the Fibroadenoma. Timepoint: At the beginning of the study (before the intervention) and 6 months after starting the intervention. Method of measurement: sonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sadaf Alipour

Tehran University of Medical Sciences

salipour@sina.tums.ac.ir+98 21 7788 3283

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 21, 2026