Evaluation the analgesic effect of fluoxetine in mastalgia due tofibrocystic breast disease
Design
In this study, 70 women with breast pain are devided by inclusion criteria in two groups.The intervention group: receive 600 units of vitamin E daily and 10 mg of fluoxetine for 8 weeks. Control group: receive 600 units of vitamin E and placebo daily for 8 weeks. After two months, the severity of the pain will be checked . All drugs are manufactured by Tehran Drug Company.
Settings and conduct
Phase 3 clinical trial study; Shahrekord Women's Clinic; Double blind
that the researcher and the patient will have no aware of the contents of the capsules; Random allocation to two intervention and control groups
Participants/Inclusion and exclusion criteria
Women 20 to 50 years with fibrocystic breast disease-induced mastalgia; Women with mastalgia criterion equal to or greater than four on the VAS scale;
Women whose pain lasts more than 5 days per month; The patient has no known history of brest disease or malignancy
Intervention groups
Intervention group: receive 600 units of vitamin E daily and 10 mg of fluoxetine for 8 weeks.
Control group: receive 600 units of vitamin E and placebo daily for 8 weeks.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200205046381N1
Registration date:2020-02-28, 1398/12/09
Registration timing:prospective
Last update:2020-02-28, 1398/12/09
Update count:0
Registration date
2020-02-28, 1398/12/09
Registrant information
Name
Maryam Pornafisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0065
Email address
nafisi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effect of fluoxetine and vitamin E with vitamin E only in mastalgia due tofibrocystic breast disease
Public title
Comparing the analgesic effect of fluoxetine and vitamin E with vitamin E only in breast pain due tofibrocystic breast disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 20 to 50 years old with fibrocystic breast disease-induced mastalgia
Women with mastalgia criterion equal to or greater than four on the VAS scale
Women whose pain lasts more than 5 days per month
The patient has no known history of brest disease or malignancy
Exclusion criteria:
Women with physical and mental illnesses such as polycystic ovary disease
Obese female patients 30≥BMI
Women who have been on hormone therapy for the past three months
Women who use contraceptives
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of the participants to the intervention 1 and 2 groups will be done using random allocation software. Then, envelopes prepare according to the number of participants in the study. It will be recorded number one on the first envelope, the second envelope number 2, and etc. In each envelope, the assignment of each individual is determined by the software. In this way, the specified envelope for each individual will be opened and the individual will be assigned to one of the intervention 1 and/or intervention 2 groups according to the option recorded in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
A B C code is required for each group. All fluoxetine, vitamin E and placebo medications are put into the same capsules by the manufacturer and the investigator and particpant are not aware of the type of drug used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.SKUMS.REC.1397.298
Health conditions studied
1
Description of health condition studied
Mastalgia
ICD-10 code
N60.2
ICD-10 code description
Fibroadenosis of breast
Primary outcomes
1
Description
Pain
Timepoint
Baseline and two months after intervention
Method of measurement
VAS Questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive 600 units of vitamin E daily and 10 mg of fluoxetine per oral for 8 weeks. All drugs are manufactured by Tehran Drug Company
Category
Treatment - Drugs
2
Description
Control group: receive 600 units of vitamin E and placebo daily per oral for 8 weeks. All drugs are manufactured by Tehran Drug Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital of Shahrekord
Full name of responsible person
Shabanian Sheida
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
shabanian@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Mehraban Sadeghi
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3334 2414
Email
sadeghi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
009832220016
Email
shabanian@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
818718791
Phone
+98 38 3222 0016
Email
shabanian@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718791
Phone
+98 38 3222 0016
Email
shabanian@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data in article format
When the data will become available and for how long
one years
To whom data/document is available
researchers
Under which criteria data/document could be used
publication
From where data/document is obtainable
journals
What processes are involved for a request to access data/document