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

Phase 3

Recruiting

• Conditions: ovarian cysts.; Other and unspecified ovarian cysts; N83.2

• Registration Number: IRCT20140820018866N9
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.