Objectives: Evaluation of the effect of cabergoline ( dopamine receptor agonist) on uterine myoma.
Design: Clinical trial
Setting and conduct: single blind.
Participants: 20-40 years old women with symptomatic myoma.
Inclusion criteria: symptomatic myoma including abnormal uterine bleeding ( after excluding the other etiologies), pelvic pain, and myoma in ultrasound with a minimum size of 2 centimeters.
Exclusion criteria: severe bleeding; pregnancy; breast feeding; using any hormone or sedative; any other pathology in ultrasound;any known hormonal problems and any conditions need to an emergency treatment.
Intervention: Group A, treatment with 0.5 mg cabergoline weekly for 3 months.
Group B, observation for 3 months without cabergoline.
Main outcome: minimum reduction of 20% in the size of myoma
Other outcomes: reduction of the symptoms including pelvic pain, duration of the menstruation and amount of menstrual bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403092624N12
Registration date:2014-04-12, 1393/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2015-03-10, 1393/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of cabergoline (dopamine receptor agonist) on the size and symptoms of uterine myoma in women with myoma.
Public title
Treatment of uterine myoma.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: symptomatic myoma including abnormal uterine bleeding ( after excluding the other etiologies), pelvic pain, and myoma in ultrasound with a minimum size of 2 centimeters.
Exclusion criteria : severe bleeding; pregnancy; breast feeding; using any hormone or sedative; any other pathology in ultrasound; any known hormonal problems and any conditions need to an emergency treatment.
Age
From 20 years old to 40 years old
Gender
Female
Phase
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences.
Street address
Keshavarz Boulvard, Ghods Cross.
City
Tehran
Postal code
Approval date
2014-01-04, 1392/10/14
Ethics committee reference number
92/د/130/ 2298
Health conditions studied
1
Description of health condition studied
fibromyoma of uterus
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus; fibromyoma of uterus
Primary outcomes
1
Description
Change in the size of myoma.
Timepoint
3 months after treatment.
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Change of the symptoms including pelvic pain and amount of bleeding.
Timepoint
3 months after treatment.
Method of measurement
Questionair and VAS
Intervention groups
1
Description
Intervention group:prescription of weekly 0.5 mg cabergoline for 3 months.
Category
Treatment - Drugs
2
Description
Control group: monitoring without drug prescription for 3 months.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Iran University of Medical Sciences.
Full name of responsible person
Dr Seyed Javad Mousavi
Street address
Hemmat High way, Chamran Cross.
City
Tehran
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 ,Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Other areas of specialty/work
Street address
Molavi Avenue, Molavi Cross.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)