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Comparing the effect of Metformin and Megestrol acetate on endometrial histology in patients with disordered proliferative or hyperplastic endometrium. A RCT

Protocol summary

Summary
Recently several studies have shown that the anti-diabetic biguanide metformin have a protective effect against some types of cancer including endometrial carcinoma. The objective of this randomized, clinical trial is to investigate the effect of metformin compared to megestrol acetate on endometrium in patients with menorrhagia who diagnosed to have disordered proliferative or hyperplastic endometrium without atypia. Sixty patients in equal groups, 15 participant in each group with abnormal uterine bleeding and having disordered proliferative or hyperplastic endometrium without atypia who have consent to participate were included. Patients who have allergy to metformin, who have renal failure, nausea, vomiting, anorexia, anemia, cutaneous lesions or not satisfied to participate in the study, were excluded. First group will receive metformin which is started by 500mg orally in the morning for one week, then twice daily for the second week, and 500mg in the morning + 1000mg at night for the third week. Finally all patients in metformin group will receive 850 mg metformin twice daily for 3 months. The second group will receive megestrol acetate 40mg/day for 3 months. After three months both groups will undergo endomertrial biopsy. Early outcome measures include improvement of the symptoms, response to treatment and endometrial histology.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205265283N4
Registration date: 2013-03-16, 1391/12/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-16, 1391/12/26
Registrant information
Name
Manizheh Sayyah Melli
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3741
Email address
sayyahmellim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-08-20, 1391/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Metformin and Megestrol acetate on endometrial histology in patients with disordered proliferative or hyperplastic endometrium. A RCT
Public title
Comparing the effect of Metformin and Megestrol acetate on endometrial histology in patients with disordered proliferative or hyperplastic endometrium. A RCT
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with abnormal uterine bleeding and havingdisordered proliferative or hyperplastic endometrium with or without atypia. Consent to participate. Exclusion criteria: Patients who have allergy to metformin, Patients with renal failure, nausea, vomiting, anorexia, anemia, cutaneous lesionsor not satisfied to participate in the study.
Age
From 20 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz University of medical Sciences
Street address
Golgasht Ave., Vice Chancellor deputy of Research, Tabriz University of medical Sciences
City
Tabriz
Postal code
Approval date
2012-04-18, 1391/01/30
Ethics committee reference number
862/4/5

Health conditions studied

1

Description of health condition studied
Patients with abnormal uterine bleeding and have disordered proliferative or hyperplastic endometrium with or without atypia
ICD-10 code
N85.0
ICD-10 code description
Endometrial glandular hyperplasia

Primary outcomes

1

Description
Endometrialpathology
Timepoint
before surgery
Method of measurement
Pathologic assessment

2

Description
Endometrial Histologic type
Timepoint
Three months after medical therapy
Method of measurement
Microscopic assessment

Secondary outcomes

empty

Intervention groups

1

Description
First group: fifteen cases with disordered proliferative endometrium , 15 cases with hyperplastic atypical endometrium and 15 cases with hyperplasticendometrium and without atypia who referred to Alzahra Teaching Hospital, are included and after getting written informed consent, metformin is given for 3 months, then endometrial biopsy will be carried out and the response to therapy will be compared according to the pathologic results.
Category
Treatment - Drugs

2

Description
Second group: fifteen cases with disordered proliferative endometrium , 15 cases with hyperplastic atypical endometrium and 15 cases with hyperplastic endometrium and without atypia who referred to Alzahra Teaching Hospital, are included and after getting written informed consent, megestrol acetate is given for 3 months, then endometrial biopsy will be carried out and the response to therapy will be compared according to the pathologic results.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Manizheh Sayyah-Melli
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Street address
Alzahra Hospital, South ArteshAve.,Tabriz, Iran.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Sayyah-Melli
Position
Full Professor
Other areas of specialty/work
Street address
South Artesh Ave.,Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Sayyah-Melli
Position
Full Professor
Other areas of specialty/work
Street address
South ArteshAve.,Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Manizheh Sayyah-Melli
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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