Aim of research is the study of Levothyroxin efficacy in euthyroid patient suffering from dysfunctional uterine bleeding. The method of research is randomized triple blind placebo controlled clinical trial. Study population are female patients suffering from dysfunctional uterine bleeding refferedto Taleghani Hospital and Amiralmomenin HospitalsArak, Iran. Inclusion criteria: age range 35 to 55 years and dysfunctional uterine bleeding.
Exclusion criteria: pregnancy; diabetes mellitus; hyperprolactinemia; coagulopathy; uterine fibroma; endocervical and endometrial polyp; atypical hyperplasia or adenocarcinoma; ovarian cyst; ovarian mass; hormontherapy; thyroid dysfunction and contraindication of oral contraceptivpills. 120 patients are randomly divided in two groups (intervention and control). Both groups recieve oral contraceptive pill for 3 months. In addition to oral contraceptive intervention group recieve Levothyroxin 50 microgram/day and controlled group recieves placebo.The time of intervention is 3 months from the start date. Primary outcome is change in severity of uterine bleeding .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303294686N2
Registration date:2013-04-09, 1392/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-09, 1392/01/20
Registrant information
Name
Mehri Jamilian
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
mjamilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr.Saeed changizi Ashtiyani (Arak University of Medical Sciences, vice president of education and research)
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Levothyroxin in euthyroid patient suffering from dysfunctional uterine bleeding
Public title
The efficacy of Levothyroxin in euthyroid patient suffering from dysfunctional uterine bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range 35 to 55 years and dysfunctional uterine bleeding.
Exclusion criteria: pregnancy; diabetes mellitus; hyperprolactinemia; coagulopathy; uterine fibroma; endocervical and endometrial polyp; atypical hyperplasia or adenocarcinoma; ovarian cyst; ovarian mass; hormontherapy; thyroid dysfunction and contraindication of oral contraceptivpills .
Age
From 35 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
basij square
City
Arak
Postal code
3819691187
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
4-139-91
Health conditions studied
1
Description of health condition studied
Dysfunctional uterine bleeding
ICD-10 code
N93
ICD-10 code description
Other specified abnormal uterine and vaginal bleeding
Primary outcomes
1
Description
Severity of uterine bleeding
Timepoint
Before intervention and at the end of intervention
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Drug side effects
Timepoint
Before intervention and every 1 month
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group recive oral contraceptive pill plus Levothyroxin 50 microgram /day for 3 months .
Category
Treatment - Drugs
2
Description
Controlled group recive oral contraceptive pill plus placebo for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital -Amiralmomenin Hospital
Full name of responsible person
Mehri Jamilian
Street address
Taleghani Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University Medical of Sciences
Full name of responsible person
Dr. Ashtiany
Street address
Basij square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University Medical of 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
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology, Assistant professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1278 0660
Fax
Email
mjamilian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak Unicesversity of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric
Other areas of specialty/work
Street address
Basij square
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3536
Fax
+98 86 1417 3639
Email
mjamilian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Assistant professor .Board of Obstetric
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3816149369
Phone
+98 86 1278 0660
Fax
Email
mjamilian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)