Objective:comparison between metformine and mejestrol for the treatment of simple endometrial hyperplasia.
Design:randomized clinical trial.
setting and conduct:in one group metformine and in the other group mejestrol will be prescribed for 12 weeks.
Participants:Inclusion criteria: ultrasound which confirms endometrial thickening and simple endometrial hyperplasia without atypia in endometrial sampling.
exclusion criteria: history of intolerance to metformine or mejestrol; using metformine during previous 6 months; history of hepatic or renal disorders; plasma glucose of less than 60 mg/dl or more than 200 mg/dl ; current using of any medication, any gynecologic neoplasia; using any kind of hormones.
Interventions:in one group metformine and in the other group mejestrol will be prescribed for 12 weeks.
Main outcome:improvement in endometrial hyperplasia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506252624N18
Registration date:2016-03-22, 1395/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-22, 1395/01/03
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between metformine and mejestrol for the treatment of endometrial hyperplasia
Public title
Treatment of endometrial hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ultrasound which confirms endometrial thickening and simple endometrial hyperplasia without atypia in endometrial sampling.
exclusion criteria: history of intolerance to metformine or mejestrol; using metformine during previous 6 months; history of hepatic or renal disorders; plasma glucose of less than 60 mg/dl or more than 200 mg/dl ; current using of any medication, any gynecologic neoplasia; using any kind of hormones.
Age
No age limit
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed as stratified block
randomization.