Comparative Effect of Using Megestrol Alone and its Combination with Metformin in the Treatment of Endometrial Hyperplasia without Atypia

Determining the comparative effect of megestrol alone and its combination with metformin in the treatment of endometrial hyperplasia without atypia

A clinical trial with two parallel intervention groups, single-blind, randomized by lottery method, phase 3 on 60 patients.

This studty conducted on women with endometrial biopsy based on endometrial hyperplasia without atypia, referring to Imam Reza and Imam Ali (AS) Shahrekord Clinic in 1401. Samples will be divided into two groups of 30 people, intervention and control, by a simple random method. The control group will use 40 mg of megestrol (Iran Hormone Company) daily for 14 days in a month for 3 months and the second group will use 1000 mg of metformin in addition to megestrol for 3 months. At the end of the study, the bleeding period, BMI, and Cr, ALT, Fbs, AST, CBC, will be re-measured and endometrial biopsy will be taken again from all patients.

Inclusion criteria: age over 18 years and under 75 years old, absence of contraindications for using metformin, Hb>10 and GFR>30 and BMI<25 Exclusion criteria: receiving metformin in the previous 6 months, liver and kidney disease, alcohol consumption, malabsorption, pregnancy, and description of insulin injection.

Two intervention and control groups of 30 people, the control group will use 40 mg of megestrol daily for 14 days in a month for 3 months (from the 14th day of the mense period) and the second group, in addition to megestrol, 1000 mg of metformin for 3 months.

Endimetrial Hyperplasia

The researcher assigns a number to the patients using the random allocation rule method and then puts the cards on which the patient's number is written in an envelope in a shuffle. In this method, according to the sample volume, two colors of cards (red and blue or A and B stickers) are poured into the envelope with the same number equal to the total volume of the sample. Then the eligible people entered into the study will randomly take out one of the cards from the envelope and according to the definition of the researcher, if they take the red or A card, they will enter the intervention group, and if they take the blue or B card, they will enter the control group.

The method of blinding is that the patients of the intervention and control groups are unaware of the type of drug being used, and metformin and placebo drugs will be prepared in the form of tablets with the same shape and size. Considering the type of study that is one-sided blind, after randomization And entering the groups, patients in the control group will be given megestrol and placebo, and the patients in the intervention group will be given metformin and megestrol.

To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy are published

The access period will start 6 months after the results are published

Our data is only available to researchers working in scientific and academic institutions

If there are conditions, all our data will be shared except personal information of people. The use of our data is only allowed for similar research by other researchers. All those who work in scientific and academic centers and decide do similar research can access our data.

In order to receive information, all eligible people can collect data by referring to the person responsible for the project. E-mail:paridokht.nourian@gmail.com ,09132326474

To receive information after sending the request, the requests will be reviewed within 10 days, and if the conditions are met, it will be sent to the provided email within 30 days.