This study is a randomized clinical trial without blinding. Referral women (100 people) who are eligible to enter the study are randomly divided (using the rand function of Excel software) into two case groups (letrozole consumption) and control groups (triptorline vial).
Settings and conduct
This study is conducted in Al-Zahra Hospital, Isfahan, as a randomized clinical trial, without blinding. 100 women were randomly divided into two groups: case (letrozole) and control (triptorline vial) and they were given medication.Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with symptomatic uterine fibroids
Abnormal uterine bleeding
Non-entry criteria: pregnancy
Other uterine diseases such as malignancy
Hormonal disorders
Taking other drugs for the treatment of uterine fibroids
Exclusion criteria: The occurrence of unwanted side effects of drugs
Deterioration of patients during the treatment period
Intervention groups
In the case group, letrozole 5 mg tablets are taken daily for 3 months.
In the control group, a 3.75 mg vial of Triptorlin (Company: Hemafarmed) was administered once a day for 3 months.
Main outcome variables
Uterine fibroid size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N10
Registration date:2024-08-16, 1403/05/26
Registration timing:prospective
Last update:2024-08-16, 1403/05/26
Update count:0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of letrozole with triptorline on reducing complications in women with symptomatic uterine fibroids
Public title
Letrozole in symptomatic uterine fibroids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with symptomatic uterine fibroids
Abnormal uterine bleeding
Exclusion criteria:
pregnancy
Other uterine diseases such as malignancy
Hormonal disorders
Taking other drugs for the treatment of uterine fibroids
The occurrence of unwanted side effects of drugs
Deterioration of patients during the treatment period
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Referrals who are eligible to enter the study are randomly divided into two groups, case and control. In this study, the segmentation of individuals is performed as a quadruple block. In this method A reflects the person who receives the intervention and B represents the person in the control group. Considering the four -block block, we give the AABB Code 0, to the ABAB Code 1, to ABBA Code 2, to BAAB Code 3, to BBAA Code 4 and BABA Code 5 to 9. Then, using the random numbers table, select the starting point randomly and then consider the numbers in a row or column. Considering the order of the table numbers, we replace each number we have hit. Finally, 3 people will be divided into two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-12-29, 1401/10/08
Ethics committee reference number
IR.MUI.MED.REC.1401.348
Health conditions studied
1
Description of health condition studied
Symptomatic Uterine Fibroids
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified
Primary outcomes
1
Description
Uterine fibroid size
Timepoint
Three months after taking the drug
Method of measurement
Clinical examination of the patient
Secondary outcomes
empty
Intervention groups
1
Description
Case group: In the Case group, letrozole 5 mg tablets (From the importing company: Shafayab Gostar) are taken daily for 3 months.
Category
Treatment - Drugs
2
Description
In the control group, a 3.75 mg vial of Triptorlin (Company: Hemafarmed) was administered once a day for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Shamin Ghobadi
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 432 5676
Email
shaminghobadi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shamin Ghobadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 432 5676
Email
shaminghobadi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shamin Ghobadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 432 5676
Email
shaminghobadi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shamin Ghobadi
Position
Isfahan
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 432 5676
Email
shaminghobadi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available