Determining the Effect of Adding Metformin to Progesteron in the Treatment of Endometrial Hyperplasia In patients referred to Forqani Hospital with the diagnosis of endometrial hyperplasia
Design
Randomized, with a control group with parallel group trial without blinded. Phase 3 on 134 patients(two groups of 67) . Allocation of treatment to groups is done by randomization method with permutation blocks with 6 blocks.
Settings and conduct
Women diagnosed with endometrial hyperplasia referring to Forqani Hospital will be included in the study if they meet the conditions for entering the study after obtaining written consent. By using the block randomization method, treatment allocation will be done randomly in two groups of 67 people. Patients in the first group will be prescribed 500 mg metformin and 20 mg megestrol daily for 3 months. Patients in the second group will only receive 20mg of megestrol for 3 months. Then, after 3 months, for 3 weeks, the patients do not receive medicine, and after 3 weeks, the patients undergo curettage. They will be examined by a pathologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having a diagnosis of pathology (AEH) or having a diagnosis of EEC
Non-entry criteria:
Blood sugar less than 60 or more than 200 mg/dL
Alcohol addiction
Severe infection
Severe chronic disease (impairment of heart, liver, lung or kidney function)
Age 18 to 45 years
Having informed consent to enter the study
Intervention groups
Intervention group: 500 mg metformin and 20 mg megestrol daily for 3 months.
Control group: 20 mg megestrol and placebo for 3 months.
Main outcome variables
endometrial hyperplasia
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20221015056181N1
Registration date:2022-12-04, 1401/09/13
Registration timing:prospective
Last update:2022-12-04, 1401/09/13
Update count:0
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
Roya Hoseinzadeh senseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 9516
Email address
r.hoseinzadeh.s@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of The Effect Of adding Metformin to progesterone in The Treatment Of Endometrial Hyperplasia
Public title
Treatment Of Endometrial Hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a pathological diagnosis of EEC or AEH
Desire to preserve fertility
Not having suspicious signs of tissue invasion
No hormonal treatment in the last 6 months
Obtain informed consent
Age 18 to 45 years
Exclusion criteria:
Contraindications for metformin
Contraindications for progesterone (megestrol)
Use of metformin in the last six months
Blood sugar less than 60 or more than 200 mg/dL
Using oral contraceptives or estrogen or progesterone
Alcohol addiction
Severe infection
Severe chronic disease (impairment of heart, liver, lung or kidney function)
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences