The objective of this randomized, clinical trial is comparing the effect of Aromatase inhibitor (Letrozol) + Cabergoline (Dostinex) and letrozol alone on uterine myoma regression. women with Myoma larger than 4 cm and irregular menstrual cycle; Candidate for myomectomy or hysterectomy or treatment of infertility Which referred to Al-Zahra hospital in Tabriz ,will be Checked.Patients were randomized using a random number table Random list of software Rand (Rand Company) are divided into two groups.This table has two rows and columns with a random number that matures in 99 rows and columns and rows and columns into blocks of five -digit numbers together and form were separated to facilitate its use. 38 people Patients with age over 45 years and Patients with a history of drug treatment or surgery for uterine myoma and uterine bleeding Will be excluded. Intervention Group (A) :Letrozole+ Dastinks and control group(B): Letrozole alone. In Group(A): Letrozole 2.5 mg per day and Dastinks 0.5 mg per week for 12 weeks from the first day of the period and in the control group:Letrozole 2.5 mg per day of the first day of the period. A week after the end of treatment and receiving the drug patients will be follow-up with using ultrasound . Primary Outcome in this study is Deterioration of uterine myoma deterioration of uterine myoma. This is not a blind study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506205283N12
Registration date:2015-08-22, 1394/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-22, 1394/05/31
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
2015-07-03, 1394/04/12
Expected recruitment end date
2016-07-02, 1395/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Aromatase inhibitor (Letrozol) + Cabergoline (Dostinex) and letrozol alone on uterine myoma regression
Public title
Comparing the effect of Aromatase inhibitor (Letrozol) + Cabergoline (Dostinex) and letrozol alone on uterine myoma regression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with Myoma larger than 4 cm and irregular menstrual cycle; Candidate for myomectomy or hysterectomy or treatment of infertility
Exclusion criteria: Age over 45 years; Uterine disease; Kidney disease; Liver disease; Antipsychotic drugs; Patients with history of use estrogen and progesterone in the last month; Patients with a history of drug treatment or surgery for uterine myoma and uterine bleeding
Age
To 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were randomized using a random number table Random list of software Rand (Rand Company) are divided into two groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
TBZMED.REC.1394.264
Health conditions studied
1
Description of health condition studied
Uterine myoma
ICD-10 code
D25.9
ICD-10 code description
Leiomyoma of uterus, unspecified
Primary outcomes
1
Description
Deterioration of uterine myoma
Timepoint
12 weeks after starting treatment
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Menstrual regulation
Timepoint
After treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
The intervention group: Letrozole ( Made in Iran , Iran hormone ) 2.5 mg per day and Dostinex (Made in Iran , the company Aboureihan ) 0.5 mg per week for 12 weeks from the first day of the period
Category
Treatment - Drugs
2
Description
In the control group:Letrozole ( Made in Iran , Iran hormone ) 2.5 mg per day of the first day of the period
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.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 3556 9543
Fax
Email
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 3556 9543
Fax
Email
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
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)