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Comparison of metformin-megestrol combination and megestrol alone on endometrial histology in patients with disordered proliferative or hyperplastic endometrium.

Protocol summary

Summary
The objective of this randomized, clinical trial is to investigate the effect of metformin and megestrol with megestrol only on histologic endometrial cells in patients with proliferative and hyperplastic endometrium without atypia. 84 patients in equal groups, 42 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. In the first group, metformin 500 mg twice a day with megestrol 40 mg daily and the other group of megestrol acetate (brand Jstyran, made in Persia, now Iran Hormone) will be prescribed 40 mg daily for 3 months. 2 weeks after discontinuation of therapy, again each endometrial biopsy was performed and the pathological samples will be compared to their treatment. Early outcome measures include improvement of the symptoms, response to treatment and endometrial histology.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201410275283N11
Registration date: 2014-11-28, 1393/09/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-28, 1393/09/07
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
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of metformin-megestrol combination and megestrol alone on endometrial histology in patients with disordered proliferative or hyperplastic endometrium.
Public title
Comparison of metformin-megestrol combination and megestrol alone on endometrial histology in patients with disordered proliferative or hyperplastic endometrium.
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
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 84
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
ice chancellor for Research,Tabriz University Of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
93121

Health conditions studied

1

Description of health condition studied
Patients with abnormal bleeding and endometrial proliferative and Hayprplastyk with irregular glands with and without atypia
ICD-10 code
N85.0
ICD-10 code description
Endometrial glandular hyperplasia

Primary outcomes

1

Description
Endometrial pathology
Timepoint
Before surgery
Method of measurement
Pathological evaluation

2

Description
Histologic types of endometrial
Timepoint
Three months after the first dose
Method of measurement
Microscopic examination

Secondary outcomes

empty

Intervention groups

1

Description
In the first group, metformin 500 mg twice a day with megestrol 40 mg daily
Category
Treatment - Drugs

2

Description
The second group of megestrol acetate 40 mg daily for 3 months will be prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,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
Dr.Manizhe Sayyah-Melli
Position
prof. of Ob & Gyn
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3556 9543
Fax
Email
wrhrcenter@gmail.com; lahroudin@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
Dr.Manizheh Sayyah-Melli
Position
prof. of Ob & Gyn
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com; lahroudin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Position
prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com; lahroudin@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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