Comparison effect ofmefenamic acid and tranexamic acid ontreatmentofmenorrhagiasecondrydueIUD(TCU380)user referring to health clinic in Bandarabbass1390
The aim of this study was to compare the effects of Mefenamic acid and Tranexamic acid in the treatment of menorrhagia secondary in users (IUDTCU380), respectively. Samples in this study 84 women complained of the menorrhagia secondary to the use of the IUD clinic in the city of Bandar Abbas were.. Participants in the study fill a questionnaire menorrhagia before treatment and after diagnosed ،wereentering the study and treated for two cycles were performed for Afrard and after two months were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205092515N8
Registration date:2012-07-05, 1391/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Maasumeh Kaviani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4251
Email address
kavianm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences and Health Services
Expected recruitment start date
2011-09-30, 1390/07/08
Expected recruitment end date
2012-06-14, 1391/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect ofmefenamic acid and tranexamic acid ontreatmentofmenorrhagiasecondrydueIUD(TCU380)user referring to health clinic in Bandarabbass1390
Public title
Comparison effect ofmefenamic acid and tranexamic acid in the treatment of bleeding secondary to the use of IUD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness to cooperate in women
using TCU380 (IUD); no experiment coagulation disorders and systemic disorders; none ultrasound malignancies; counting padding to verify menorrhagia; none use of other methods of contraception;
no disease of the digestive and liver, brain and kidney; no trombosis; no history of allergy to mefenamic acid and hemoglobin; no history thrombosis and clotting disorders; no history of irregular uterine bleeding; uterine size between 9-6 cm; hemoglobin above 10; having 1 to 5 parity and no unwanted pregnancy.
Exclusion criteria: sensitivity to the drug use
the drug note continued; dissatisfaction with the plan; unwanted pregnancy with IUD and IUD removal.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences and Health Services
Street address
Shiraz - Namazi Square -Square Namazi- fatemia School of Nursing Midwifery
City
Shiraz
Postal code
Approval date
2011-12-13, 1390/09/22
Ethics committee reference number
CT-90_5158
2
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences and Health Services
Street address
Shiraz - Namazi Square -Square Namazi- fatemia School of Nursing Midwifery
City
shiraz
Postal code
Approval date
2011-08-21, 1390/05/30
Ethics committee reference number
25180
Health conditions studied
1
Description of health condition studied
menorrhagia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Menorrhagia
Timepoint
before intervention and first and second months after intervention
Method of measurement
PBAC Table
Secondary outcomes
1
Description
Side effects
Timepoint
One month and two months after intervention
Method of measurement
Standard questionnaire
Intervention groups
1
Description
Tranksymyk acid 250 mg capsule three times a day (every 8 hours) Mefenamic acid 250 mg capsule three times a day (every 8 hours)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hormozgan University of Medical Sciences - Health Centers
Full name of responsible person
Street address
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Mr.Skandari
Street address
Shiraz - Namazi Square - Building University of Medical Sciences
City
Shiraz
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, Shiraz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
M. Kaviani
Position
MD of midwifery
Other areas of specialty/work
Street address
Shiraz - Fatima School of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 917 710 3797
Fax
Email
kavianm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
M. Kavaini
Position
MD of midwifery
Other areas of specialty/work
Street address
Shiraz - Namazi Square - Fatima School of Nursing and Midwifery
City
Shiraz
Postal code
Phone
Fax
+98 71 1647 4252
Email
kavianm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)