Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000543381
Ethics application status
Approved
Date submitted
25/09/2008
Date registered
28/10/2008
Date last updated
28/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
bromocriptine versus cabergoline for the symtomatic treatment of cyclic mastalgia
Scientific title
bromocriptine versus cabergoline for the symtomatic treatment of cyclic mastalgia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mastalgia in premenstrual period 3752 0
monthly breast pain 3753 0
Condition category
Condition code
Reproductive Health and Childbirth 3931 3931 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cabergoline will be given to intervention group at premenstrual period to decrease premenstrual breast pain.Patients will take one oral tablet cabergoline(0.5mg) at 14th day of menstruation and second oral tablet (0.5mg)at next week same day(one tablet in a week).Participants will take cabergoline for three consecutive menstrual cycles.
Intervention code [1] 3466 0
Treatment: Drugs
Comparator / control treatment
Patients taking bromocriptine constructed the control group,because this drug have been widely used for the treatment of mastalgia and its efficiacy and adverse effects were well known.Control group will take oral half tablet(2.5 mg)bromocriptine every day begining from 14th day of menstrual cycle ,to the first day of menstruation.This therapy will continue during three consecutive menstrual cycles.
Control group
Active

Outcomes
Primary outcome [1] 4827 0
Breast pain visual analogue score(VAS).Patients will be given visual analogue score chart,on which numbers from 1 to 10 were located.Patient will sign one of these numbers according to their feeling of severity of breast pain,before the treatments and each month after the menstruation during three months.
Timepoint [1] 4827 0
Primary outcome will be measured at the end of menstruation for three months
Secondary outcome [1] 8149 0
drug adverse effects.Frequency of nausia,frequency of vomitting,frequency of headache,frequency of hypotensive syncope will be defined.
Timepoint [1] 8149 0
after 3 months of therapy,evaluation of adverse effects,Patients will be asked for frequently seen adverse effects when they visit hospital for the evaluation of their visual analogue score after each menstrual bleeding during treatment.Total frequency of these adverse effects for both groups will be calculated.

Eligibility
Key inclusion criteria
healthy women at reproductive age, having monthly mastalgia of moderate or severe which breast pain relieves after menstruation.
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
breast Cancer,uncontrolled diabetus,hypertension or other chronic illnesses,breast operation or radiotherapy or other breast diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1234 0
Turkey
State/province [1] 1234 0
istanbul

Funding & Sponsors
Funding source category [1] 3928 0
Hospital
Name [1] 3928 0
sisli etfal training and research hospital
Country [1] 3928 0
Turkey
Primary sponsor type
Hospital
Name
sisli etfal training and research hospital
Address
sisli etfal training and research hospital,34760 sisli/istanbul
Country
Turkey
Secondary sponsor category [1] 3644 0
None
Name [1] 3644 0
Address [1] 3644 0
Country [1] 3644 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28978 0
Address 28978 0
Country 28978 0
Phone 28978 0
Fax 28978 0
Email 28978 0
Contact person for public queries
Name 12135 0
yavuz aydin
Address 12135 0
atakent mah.soyakolimpiakentsitesi D:12 blok no:31 halkali/istanbul
Country 12135 0
Turkey
Phone 12135 0
902124951616
Fax 12135 0
Email 12135 0
yavuzay@istanbu.edu.tr
Contact person for scientific queries
Name 3063 0
yavuz aydin
Address 3063 0
atakent mah.soyakolimpiakentsitesi D:12 blok no:31 halkali/istanbul
Country 3063 0
Turkey
Phone 3063 0
902124951616
Fax 3063 0
Email 3063 0
yavuzay@istanbul.edu.tr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.