Fibrocystic Changes of the braest. Disorder of breast, unspecified
Conditions
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
15 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age of fertility FCC diagnosis based on history, examination and ultrasound.
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 During the study or three months before the study began Hormonal disorders and metabolic diseases such as hypo or hyperthyroidism, metabolic syndrome, diabetes, severe hyperlipidemia, galactorrhea 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
| Measure | Time frame |
|---|---|
| Mastalgia. Timepoint: At the beginning of the study (before the intervention), three months and six months after the intervention began. Method of measurement: Questionnaire (Visual Analog Scale).;Breast nodularity. Timepoint: At the beginning of the study (before the intervention), three months and six months after the intervention began. Method of measurement: Clinical examinations by the surgeon and registration in a standard checklist designed by the researchers.;Breast Tenderness. Timepoint: At the beginning of the study (before the intervention), three months and six months after the intervention began. Method of measurement: Clinical examinations by the surgeon and registration in a standard checklist designed by the researchers.;Ultrasound findings related to fibrocystic changes in the breast. Timepoint: At the beginning of the study (before the intervention) and six months after the intervention began. Method of measurement: By ultrasonographic scan and recording on a standard checklist designed by the researchers. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Sadaf Alipour
Tehran University of Medical Sciences
Outcome results
None listed