1. Home
  2. Approved trials
  3. » فارسی

Letrozole versus Megestrol acetate for treatment of simple endometrial hyperplasia without Atypia

Protocol summary

Summary
Aims: Comparison between Letrozoleand Megestrol acetate in treatment of women having simple endometrial hyperplasia without Atypia; study design: Randomized (Balanced (permuted) block randomization) double-blind comparison of two drugs- Clinical Trial 2-3; Study population: women 44 to 50 years; Main inclusion criteria: The presence of hyperplasia without Atypi in endometrial biopsy, Unusual diameter of endometrial, Unusual abnormal uterine bleeding; Main exclusion criteria: Performing hormone therapy during the last 6 months, wanting to get pregnant for at least3months from now, Focal endometrial lesions such as Leiomyoma , having Atypical or complex hyperplasia, Breast-feeding, history of vascular disease or clotting disorders, Hypertension؛ Sample size: Two groups of 25 individuals, a total of 50 people ; Study intervenes: Women 44 to 50 years old, complaining about abnormal uterine bleeding will have ultra sound terrace vaginal basis by the Sonography unit. In case of having a thick abnormal endometrium, the will have endometrial biopsy by pathologists unit using Pipelle method. Serum estradiol levels will also be calculated. After identifying women suffering from simple endometrium hyperplasia without cytologic atypical, they will divided into two groups. The first group will be prescribed Megestrol acetate, and the second group will be prescribed Letrozole. After the end of treatment, the serum estradiol level will be calculated. The Patients will have endometrial biopsy three to four weeks after the end of treatment, and the results will be compared; Intervention time: After diagnosing Women suffering from simple endometrium hyperplasia without cytologic Atypia; Outcome measures: Abnormal thickening of the endometrium (more than 12 millimeter) along with abnormal uterine bleeding.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031011504N5
Registration date: 2015-12-12, 1394/09/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Sanam Moradan
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 0066
Email address
smoradan@sem.ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Expected recruitment start date
2015-06-15, 1394/03/25
Expected recruitment end date
2016-09-15, 1395/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Letrozole versus Megestrol acetate for treatment of simple endometrial hyperplasia without Atypia
Public title
Compare the effect of the drug Letrozole and Megestrolto treat abnormal uterine bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 44 to 50 years, Having abnormal uterine Hemorrhage, simple hyperplasia without Atypia present in the endometrial biopsy, agreement to take part in the study, abnormal thickening of the endometrium (more than 12millimeterin reproductive age sand the pre- menopausal or the presence of endometrium 5 to 12millimeters in reproductive ages and pre- menopausal along with abnormal bleeding continuation despite medical treatment) intrans vaginal ultrasound(first evaluation via basic trans-vaginal ultrasound will be done for all research units by the sonography and in case of abnormal endometrium thickness (more than12millimeters), these people will inter the study; Exclusion criteria: Performing hormone therapy during the last 6 months, wanting to get pregnantfor at least 3 months from now, focal endometrial lesions such as Leiomyoma, having Atypi color complexly perplasia, flushing symptoms, Sleep Disorders, mood changes during the last 3 months, Breast-feeding, Having congenital uterine disorders, Hypothyroidism, Hypertension, history of vascular disease or clotting disorders, sensitivity to Progestin’s.
Age
From 44 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Boulevard,Semnan
City
Semnan
Postal code
3519899951
Approval date
2015-06-15, 1394/03/25
Ethics committee reference number
IR.SEMUMS.REC.1394.18

Health conditions studied

1

Description of health condition studied
simple hyperplasia
ICD-10 code
N80-N98
ICD-10 code description
No inflammatory disorders of female genital trac

Primary outcomes

1

Description
Endometrial hyperplasia without Atypia simple cytologic
Timepoint
Before and after the intervening
Method of measurement
Trans-vaginal ultra sound and endometrial biopsy basis

2

Description
Abnormal uterine bleeding
Timepoint
Before and after the interference(the twentieth to twenty fourth day of menstrual cycle)
Method of measurement
Trans-vaginal ultra sound and endometrial biopsy basis

3

Description
Premenopausal
Timepoint
Before and after the interference(20 to 24menstrual cycles)
Method of measurement
Measuring the serum level of follicle-stimulating hormone

Secondary outcomes

1

Description
Estradiol
Timepoint
Before and after the intervention.
Method of measurement
Serum levels of Estradiol

2

Description
Endometrial thickness
Timepoint
Before and after the intervening
Method of measurement
The wall thickness of the Endometrial based on ultrasound

3

Description
side effects of taking Letrozole and Megestrol acetate
Timepoint
Once per month
Method of measurement
Genera sensitivity, itching, hives and monthly sonography

4

Description
triglyceride
Timepoint
Before and after the intervention
Method of measurement
Blood levels of triglycerides

5

Description
Cholesterol
Timepoint
Before and after the intervention
Method of measurement
Blood levels of cholesterol

6

Description
Menstrual status
Timepoint
Before and after the intervention
Method of measurement
Oligomenorrhea, Polymenorrhea ,normal

Intervention groups

1

Description
He first group will be prescribed 40 milligram of Megestrol acetate (40 milligram BRENDOCARE tablet, made by Aburaihan pharmaceutical co. Iran) for two weeks in each month (A 40 milligram tablet per day). After the end of treatment, all the research units will investigate (interview and trans-vaginal Sonography) the serum Estradiol levels after the interference. The Patients will have endometrial biopsy three to four weeks after the end of treatment, and the results before and after that will be compared. The results will be investigated by international standards.
Category
Treatment - Drugs

2

Description
The second group will be prescribed 2.5 milligram of Letrozole (2.5 milligram Letrax tablet, made by Aburaihan pharmaceutical co. Iran), for two months, A tablet per day. After the end of treatment, all the research units will investigate (interview and trans-vaginal Sonography) the serum Estradiol levels after the interference. The Patients will have endometrial biopsy three to four weeks after the end of treatment, and the results before and after that will be compared. The results will be investigated by international standards.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Niaz Nik Khah
Street address
Imam Hossein Square
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Dr Mohamad Reza Asgari
Street address
Basij Boulevard
City
Semnan
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 and Technology, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Niaz Nik Khah
Position
Gynecology resident
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Imam Hossein Square, Semnan
City
Semnan
Postal code
3519899951
Phone
+98 23 3346 1433
Fax
Email
niaz_nik@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Sanam Moradan
Position
Associate Professor/ Gynecologist
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Imam Hossein Square, Semnan
City
Semnan
Postal code
3519899951
Phone
+98 23 3346 1433
Fax
Email
sm42595@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Samaneh Lavvaf
Position
BS of Statistics/ExpertAbnormal Uterin Bleeding Research Center
Other areas of specialty/work
Street address
Abnormal Uterin Bleeding Research Center, Amiralmomenin Hospital, mam Hossein Square, Semnan
City
Semnan
Postal code
3519899951
Phone
+98 23 3346 1433
Fax
Email
sama_lavvaf@yahoo.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
Loading...