A Randomized controlled clinical trial comparing the effects of aromataseinhibitor(letrozole)and gonadotropin-releasing hormone(triptoreline) on uterine leiomyoma volum
Uterine leiomyomas are benign monoclonal tumors arising from the smooth muscle cells of the myometrium.GnRHa are the most common medical therapy for uterine myomas. Since recent discovery in fibroid pathophysiologocal structure interests in using aromatase inhibitors for treating myomas have been increased.
This study was conducted as a randomized clinical trial. Twenty patients with symptomatic uterine myomas randomized into two groups. First group received 25mg letrozol tablet/day 5 days in bleeding phase of menstrual period; the other group received 3.5mg triptorelin intra muscular injection per month. Myomas size was evaluated and documented before and after medical therapy in second, 4th, 6th, and 12th weeks of study. Inclusion criteria were: age between18 to 50years old; myoma size>=5cm with abnormal vaginal bleeding, unexplained infertility, pelvic pain, dysmenorrhea and signs related to mass. Exclusion criteria were: multiple myoma size >2cm and hormonal therapy during last month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012045307N1
Registration date:2011-10-26, 1390/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-26, 1390/08/04
Registrant information
Name
Mitra Abdoli
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
abdoli@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences, Shahid Fahmidehe ave.
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-06-20, 1390/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized controlled clinical trial comparing the effects of aromataseinhibitor(letrozole)and gonadotropin-releasing hormone(triptoreline) on uterine leiomyoma volum
Public title
Decapeptid effect in myoma
Purpose
Treatment
Inclusion/Exclusion criteria
Included:Age between 18 to50 years old; myoma size equal or more than 5cm with abnormal vaginal bleeding, unexplained inferility, pelvic pain, dysmenorrea and signs related to mass.
Exclusion criteria: Multiple myoma size more than 2cm and hormonal therapy during last month
major disease
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmide aven.
City
Hamedan
Postal code
Approval date
2011-01-12, 1389/10/22
Ethics committee reference number
163576/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Myoma
ICD-10 code
M8895/0
ICD-10 code description
Myoma
Primary outcomes
1
Description
Uterus myoma size
Timepoint
Baseline, weeks 2, 4, 6 and 12
Method of measurement
Myoma size with transvaginal sonography(cm)
Secondary outcomes
1
Description
Dysuria
Timepoint
Weeks 2, 4, 6 and 12
Method of measurement
Questionnaire
2
Description
Flushing
Timepoint
Weeks 2, 4, 6 and 12
Method of measurement
Questionnaire
3
Description
Dryness of vagina
Timepoint
Weeks 2, 4, 6 and 12
Method of measurement
Questionnaire
4
Description
Dysparunia
Timepoint
Weeks 2, 4, 6 and 12
Method of measurement
Questionnaire
Intervention groups
1
Description
Tab.Letrozol 2.5 mg at day of mens
Amp.Triptorelin3.75 mg evry month(3month)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology and Infertility Ward, Fatemie Hospital
Full name of responsible person
Dr. Soghra rabiee
Street address
Fatemie Hospital
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Abas Zamanian
Street address
Hamedan University of Medical Sciences, Shahid Fahmidehe ave.
City
Hamedan
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, Hamedan 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
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soghra Rabiee
Position
Assistant Professor
Other areas of specialty/work
Street address
Fatemie Hospital
City
Hamedan
Postal code
Phone
+98 81 1827 7012
Fax
+98 81 1828 3939
Email
rabieesogol@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soghra Rabiee
Position
Assistant Professor
Other areas of specialty/work
Street address
Fatemie Hospital
City
Hamedan
Postal code
Phone
+98 81 1887 2012
Fax
+98 81 1828 3939
Email
mitabdoli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soghra Rabiee
Position
Other areas of specialty/work
Street address
Fatemieh Hospital
City
Hamedan
Postal code
Phone
+98 81 1827 7012
Fax
+98 81 1828 3939
Email
rabieesogol@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)