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The effect of metformin on breast fibrocystic changes

The comparison of the effect of metformin with vitamin E on breast fibrocystic changes in women

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016010725895N1
Enrollment
186
Registered
2016-09-17
Start date
2016-10-07
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

fibrocystic change disease of breast. Diffuse cystic mastopathy

Interventions

Intervention 1: Intervention: one tablet of Metformin 500 mg, oral, twice daily for 6 months. Intervention 2: Placebo group: vitamin E 400 mg daily, oral for six months. Intervention 3: Control group:
Treatment - Drugs
Placebo
Intervention: one tablet of Metformin 500 mg, oral, twice daily for 6 months
Placebo group: vitamin E 400 mg daily, oral for six months
Control group: don't receive any treatment.

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age between 18-40; fibrocystic breast changes Exclusion criteria: Women with malignancy; breast cancer; diabetes; using other drugs; Women with kidney, heart and lung diseases; drug intolerance

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The changes of the size of the cysts. Timepoint: The beginning of the study, the end of six months. Method of measurement: Sonography.;The changes of the number of the cysts. Timepoint: The beginning of the study, the end of six months. Method of measurement: Sonography.

Secondary

MeasureTime frame
The changes of pain score. Timepoint: The beginning of the study, the end of six months. Method of measurement: Physical examination.;The change of the tenderness score. Timepoint: The beginning of the study, the end of six months. Method of measurement: Physical examination.;The changes of the breast discharge. Timepoint: The beginning of the study, the end of six months. Method of measurement: Physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsanehTalaei

Arak University of Medical Sciences

afsanehtalaeii@yahoo.com+98 86 3417 3612

Outcome results

None listed

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