This study is a before and after controlled trial. 30 pre menopause patients, who have symptomatic liomyomatos equivalent or larger than 3 cm, take Letrozole (third generation of aromatase inhibitors). All of the patients who have this criteria are included and patients who have received hormonal therapy before this time, patients who have severe medical disorders and patients who have surgical treatment of myoma are excluded from this study. At the beginning of study uterine sonography is done and at the third day of menstural cycle the level of FSH-LH -Stradiole and ferritine are measured. Data are collected from patients about symptoms for example pelvic pressure, frequency, pelvic pain, dysmenorhea, duration and volume of menstural cycle and history of infertility. Patients are treated with 2/5 mg Letrozole daily for 90 days (continuously). At the end of study uterine sonograghy and noted lab tests are repeated and difference in clinical symptoms are asked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102015444N2
Registration date:2011-02-24, 1389/12/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-24, 1389/12/05
Registrant information
Name
Mansoore Samimi
Name of organization / entity
Kashan
Country
Iran (Islamic Republic of)
Phone
+98 36 1446 0180
Email address
samimi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Kashan University of Medical Sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of letrozole on symptomatic uterine leiomyomas
Public title
Evaluation of the effect of letrozole on symptomatic uterine leiomyomas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : pre menopause patients who have symptomatic liomyomatos equivalent or larger than 3 cm. Exclusion criteria: patients who have received hormonal therapy; patients who have severe medical disorders; patients who have surgical treatment of myoma.
Age
From 20 years old to 51 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan university of medical sciences
Street address
Ghotb Ravandi Blvd, Pezeshk Blvd
City
Isfahan
Postal code
Approval date
2010-11-30, 1389/09/09
Ethics committee reference number
2438/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Uterine Liomyoma
ICD-10 code
N85.9
ICD-10 code description
Noninflammatory disorder of uterus, unspecified
Primary outcomes
1
Description
uterine leiomyomas size
Timepoint
before &90 days after 90 days treatment
Method of measurement
sonography
2
Description
uterine size
Timepoint
before &90 days after 90 days treatment
Method of measurement
sonography
Secondary outcomes
1
Description
FSH-LH
Timepoint
before & after 90 days treatment
Method of measurement
blood sampling
2
Description
stradiol
Timepoint
before & after 90 days treatment
Method of measurement
blood sampling
3
Description
ferritine
Timepoint
before & after 90 days treatment
Method of measurement
blood sampling
4
Description
patients symptoms
Timepoint
before & after 90 days treatment
Method of measurement
questionnaire
5
Description
hemoglobin
Timepoint
before & after 90 days treatment
Method of measurement
blood sampling
Intervention groups
1
Description
Letrozole tablet, 2/5 mg, daily for 90 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi center
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Kashan University of Medical sciences
City
Kashan
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 of Kashan 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
Kashan University of Medical sciences
Full name of responsible person
Dr Mansoureh Samimi
Position
Obstetrics & gynecologist
Other areas of specialty/work
Street address
Ghotb ravandy Blvd, Pezeshk Blvd
City
Kashan
Postal code
Phone
+98 36 1446 0180
Fax
Email
samimi_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical sciences
Full name of responsible person
Ms masoumeh abedzade
Position
MSc In Midwifery
Other areas of specialty/work
Street address
Ghotb ravandy Blvd, Pezeshk Blvd
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
abedzadeh@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical sciences
Full name of responsible person
Dr. Masoumeh Abed
Position
Other areas of specialty/work
Street address
Ghotb ravandy Blvd, Pezeshk Blvd
City
Kashan
Postal code
Phone
+98 36 1446 0180
Fax
Email
M.malekin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)