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Effects of metformin in the treatment of endometrial hyperplasia

The effect of adding metformin to progesterone in patients with endometrial hyperplasia admitted to Arash hospital, Tehran, Iran

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014082018866N1
Enrollment
64
Registered
2014-12-29
Start date
2014-08-23
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

endometrial hyperplasia. Hyperplasia of endometrium: NOS cystic glandular-cystic polypoid

Interventions

Intervention 1: Control group will be teated with progesterone therapy protocol of 20-80 mg daily based on the type of hyperplasia, 14 days from the day of 14th of the menstrual cycle for three period
Treatment - Drugs
Control group will be teated with progesterone therapy protocol of 20-80 mg daily based on the type of hyperplasia, 14 days from the day of 14th of the menstrual cycle for three periods.
Intervention group, beside receiving treatment of progestrone in control group , will be treated with metformin by dose of 1000 mg for the first 4 weeks,then follow by 2000 mg metformin in remain

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: In this randomized clinical trial of patients with endometrial hyperplasia admitted to Arash hospital, Tehran, Iran in 2014 were diagnosed by biopsy sample were recruited. Inclusion criteria: women aged 18 to 75 years old with endometrial biopsy confirmed by endometrial hyperplasia; no contraindications to treatment with metformin; creatinine clearance greater than 90ml / min; using the formula of Cockroft-Gault; normal hepatic markers hemoglobin level above 10; satisfactory condition; physically fit to participate in the study. Exclusion criteria: taking metformin within the past 6 months; impaired hepatic function tests, blood sugar is less than 65 and no more than 200; history of alcohol use disorder; history of vitamin B12; pregnancy; history of insulin therapy; body mass index less than 25.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Improvement of endometrial hyperplasia. Timepoint: befor treatment,3 months after start treatment. Method of measurement: Review of Pathology.

Secondary

MeasureTime frame
Evaluation of the hepatic effects of metformin in the treatment of patients with Endometrial hyperplasia. Timepoint: start of treatment and 3 months after that. Method of measurement: blood sampling and liver tests measurements.;Reviews of metformin renal complications in the treatment of patients with Endometrial hyperplasia. Timepoint: start teatment and 3 months after that. Method of measurement: blood sampling and measuring hepatic function test.;Effect of metformin in reduce blood glocose. Timepoint: start treatment and 3 months after that. Method of measurement: blood sampling and Blood glucose measurement.;Effect of metformin on body mass index. Timepoint: start treatment and 3 months after that. Method of measurement: Measurement of height and weight and body mass index calculator.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasim Zarifi

Tehran University of Medical Sciences

nasimzarifi@yahoo.com+98 21 7788 3283

Outcome results

None listed

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