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Evaluation of the Protective Effect of Metformin against the Tamoxifen Induced Changes on Endometrium and Ovaries

Evaluation of the Protective Effect of Metformin against the Tamoxifen Induced Changes on Endometrium and Ovaries in Women with Breast Cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140820018866N9
Enrollment
100
Registered
2021-03-18
Start date
2021-04-04
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

ovarian cysts. Other and unspecified ovarian cysts

Interventions

Intervention 1: Intervention group: Metformin 500 mg ,oral tablets, three times a day for 6 months. Intervention 2: Control group: participants in the control group will take three placebo tablets dai

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Adjutant treatment of breast cancer with tamoxifen Normal pelvic exam Performance state 0-2

Exclusion criteria

Exclusion criteria: Serious diseases, heart or endocrine or other systemic diseases Use of systemic hormone therapy during past 6 months Alcohol consumption Diabetes Advanced breast cancer Having any cancer or malignancy other than breast cancer during the last three years Atypical hypoplasia or endometrial cancer abnormal ovarian cysts with the possibility of malignancy on ultrasound Contraindications for using metformin (eg: allergy to biguanides, acidosis, heart disease, alcohol consumption, gastroparesis, liver disease, hyperthyroidism or hypothyroidism, severe iron deficiency anemia, renal impairment) Unbearable and dangerous side effects of metformin (such as: abdominal pain, chest pain, chills, cholestasis, severe diarrhea, dizziness, increased liver enzymes, severe headache, hepatitis, hypoglycemia, megaloblastic anemia, myalgia, palpitations, Skin rash and rash, vomiting)

Design outcomes

Primary

MeasureTime frame
Endometrial thickness. Timepoint: Before and after treatment. Method of measurement: Vaginal ultrasoun.;Number and characteristic of ovarian cyst. Timepoint: Before and after treatment. Method of measurement: Vaginal ultrasound.

Secondary

MeasureTime frame
Changes in liver enzymes. Timepoint: Before and after treatment. Method of measurement: laboratory test.;Chenges in weight. Timepoint: Before and after treatment. Method of measurement: Scales.;Changes in weight. Timepoint: Before and after treatment. Method of measurement: Laboratory test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Tehranian

Tehran University of Medical Sciences

afsanehtehranian@yahoo.com+98 21 7788 3283

Outcome results

None listed

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