Determination of the effect of cabergoline on myoma size and uterine bleeding
Design
This study is designed as a double-blinded phase 3 controlled clinical trial, with parallel groups and a 1: 1 ratio. The sample size is considered to be 50.
Settings and conduct
This clinical trial is a double-blinded study of 50 women with uterine myomas referring to Arash Hospital's Gynecology Clinic. Aََََfter the random allocation, the first group will be treated with the cabergoline tablets and the second group will be treated with the placebo.
Participants/Inclusion and exclusion criteria
Patients aged between 20 and 50 years old who have a myoma with a size of 3 to 8 cm; abnormal uterine bleeding and pelvic pain will be included in the study.
Also, participants who are post-menopausal, have a pedunculated myoma, receiving hormonal treatments during the past 6 months, or suffering from any underlying serious diseases such as diabetes and liver disorders will not be recruited. Also, people who have a desire for myomectomy will not be included.
Intervention groups
Intervention group: 0.5 mg cabergoline tablet (weekly orally, 0.5mg Dostinex tablets per week made in Italy with a generic code of 00562 for 3 months).
Control group: placebo tablet
Main outcome variables
Uterine bleeding, Size of liomyoma,drug tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170917036227N4
Registration date:2019-06-02, 1398/03/12
Registration timing:registered_while_recruiting
Last update:2019-06-02, 1398/03/12
Update count:0
Registration date
2019-06-02, 1398/03/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
mvahid@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-02, 1398/01/13
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cabergoline on myoma size and uterine bleeding in women with myomas attending to Arash Hospital
Public title
Effect of cabergoline in treatment of uterine myoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uterin bleeding and pelvic pain
The size of the leiomyoma is between 3 and 8 cm
Aged between 20-50 years
Exclusion criteria:
Post menopause
Pedunculated myoma
Use of Hormonal or lipid-lowering agents during the last 6 months
History of cardiovascular disease, venous thromboembolism, diabetes mellitus, liver and kidney disorders, hypertension
Other malignancies
Need or desire for lyomioma surgery in the next 3 months
Pregnancy and lactation
Uncontrolled hypertension
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be designed by an epidemiologist using STATA version 13 software. The number of blocks considered will be 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomization list will be solely available to the epidemiologist. To hide the random allocation process, 50 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. A 10-digit random code will be written on each packet as the patient's identification number. When the physician announces the eligibility of a patient, the methodologist will provide the envelope and the type of treatment will be selected based on the type mentioned in the envelope. None of the patients should be aware of the type of treatment they are assigned to. The person who will evaluate the outcomes will be unaware of the random allocation process and type of treatments. Data analysis will be done by a statistician who is unaware of all processes performed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Zarafshan street, Qods town, Tehran
City
Tehran
Province
Tehran
Postal code
۸۱۴۵۵۶۱۸-۰۲۱
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.279
Health conditions studied
1
Description of health condition studied
leiomyoma
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
The size of leiomyoma
Timepoint
Before and 3 month after intervention
Method of measurement
Ulthrasonography
2
Description
Uterine bleeding
Timepoint
Before and 3 month after intervention
Method of measurement
The number of bleeding days as well as the number of pads used
3
Description
Side effects of medication
Timepoint
Before and 3 month after intervention
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.5 mg cabergoline tablet (weekly orally, 0.5mg Dostinex tablets per week made in Italy with a generic code of 00562 for 3 months)
Category
Treatment - Drugs
2
Description
Control group: Placebo (composed of sugar and starch, in terms of shape, size and color, quite similar to cabergoline: weekly one, orally)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Linda Noozandejani
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Email
hosparash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Vahid Dastjerdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
mvahid@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Vahid-Dastjerdi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
mvahid@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Vahid Dastjerdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
mvahid@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because we have plan to use our data in another studies, we are not interested to sharing the data at this time