Aim: This study compares the efficacy and acceptability of Tranexamic acid with Mefenamic acid in treating menorrhagia in order to show the most effective, and at the same time, the most acceptable drug for Iranians. Design: Single blind clinical trial. Method: During 2011-2012, 60 patients, aged 15-49, with menorrhagia who referred to Ayatollah Taleghani hospital in Tehran, Iran, were randomly divided into 2 thirty-patient groups. The first group received Mefenamic acid cap and the other received Tranexamic acid cap during the first three days of their period for 2 subsequent cycles; following that their bleeding changes were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011912190N1
Registration date:2013-02-23, 1391/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Shiva Hadadian
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
shivahadadian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2011-02-09, 1389/11/20
Expected recruitment end date
2012-03-15, 1390/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Tranexamic acid and Mefenamic acid in treating menorrhagia
Public title
Comparing the effects of Tranexamic acid and Mefenamic acid in treating heavy menstrual bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 15-49 suffering from heavy menstrual bleeding or long menstrual duration. Exclusion criteria: organic causes were excluded by history, physical exam, lab test.
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Arabi st., Yaman st., Chamran Highway
City
Tehran
Postal code
Approval date
2012-12-23, 1391/10/03
Ethics committee reference number
128
Health conditions studied
1
Description of health condition studied
menorrhagia
ICD-10 code
N80-N98
ICD-10 code description
Noninflammatory disorders of female genital tract
Primary outcomes
1
Description
Menstrual duration
Timepoint
one month before treatment,two subsequent month during treatment and one month following treatment
Method of measurement
questionnaire
2
Description
Menstrual bleeding volume
Timepoint
one month before treatment,two subsequent month during treatment and one month following treatment
Method of measurement
Pictorial chart on which patients marked the type and the number of pads theyused during menstrual bleeding..