This study is designed to evaluate the effect of cabergoline on uterine blood flow in women with PCOS. A total of 40 women with PCO syndrome, in Sanandaj, were randomly assigned into intervention or placebo groups to receive cabergoline 0.5 mg tablet weekly for 12 weeks or placebo, respectively. Uterine blood flow rate was measured by doppler sonography and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009154755N1
Registration date:2011-01-04, 1389/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-04, 1389/10/14
Registrant information
Name
Sayedeh Reyhaneh Yousefi
Name of organization / entity
Kurdestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 87 1328 5910
Email address
rey.yousefi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Kurdistan University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-03-21, 1391/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assigning the effect of administration of cabergoline on uterine perfusion in women with polycystic ovary syndrome
Public title
Assigning the effect of administration of cabergoline on uterine perfusion in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 years, living in Sanandaj
Exclusion criteria: pregnancy, breastfeeding, contraindication or adverse effects of cabergoline (nausea, vomiting, visual disturbances)
Age
From 15 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Vice-chancellor for Research and Information of Kurdistan University of Medical Sciences, MUK Campus, Pasdaran Avenue, Sanandaj, Kurdistan, Iran.
City
Sanandaj
Postal code
Approval date
2010-08-01, 1389/05/10
Ethics committee reference number
7
Health conditions studied
1
Description of health condition studied
Polycystic Ovarian Syndrome
ICD-10 code
E28.2
ICD-10 code description
POLYCYSTIC OVARY
Primary outcomes
1
Description
Uterine blood flow
Timepoint
Baaseline and after 12 weeks
Method of measurement
According mm by Doppler ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Cabergoline, 0.5 mg tablets, weekly for 12 weeks
Category
Treatment - Drugs
2
Description
to the placebo group placebo tablets similar to cabergoline 0.5 mg for 12 weeks, a week is given a pill
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in the city of Sanandaj
Full name of responsible person
Dr. Hoshang Pirfalah
Street address
Health center of Sanandaj, Salahadin Ayuobi avenue, Sanandaj, Iran
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ataollah Haidari
Street address
Vice-chancellor for Research and Information of Kurdistan University of Medical Sciences, MUK Campus, Pasdaran Avenue, Sanandaj, Kurdistan, Iran
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?