The purpose of this study is to evaluate the effect of treatment of uterine leiomyoma with letrozole therapy in premenopausal women. This research is a clinical trial study that 40 patient with including criteria (premenopausal women with age of 18-42 years and…) and excluding criteria (women with leiomyoma size of 2-5 cm and…) will be selected. It is recommended to the patients to use Letrozole which was produced by Soha Pharmaceutical Company with the dose of 2.5 mg/d for 12 weeks. The size of leiomyoma mass and the uterine volume is measured through trans-vaginal sonography in the first refer and the day of 30th and 90th after treatment. Blood exam is done in order to measure serum level of Estradiol, Gonadotropins and Hematocrit at the first, 30th and 90th day. It is asked from the patient to refer to the health office every 15 days. In these refers the patients is asked about the proper use of drugs for being certain, about the treatment side effects and also about the symptoms of leiomyoma.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402161760N32
Registration date:2014-07-05, 1393/04/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-05, 1393/04/14
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Babol University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Letrozole on Symptomatic Uterine Leiomyoma in premenopausal women
Public title
The Effect of Letrozole on Symptomatic Uterine Leiomyoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premenopausal women aged 42-18 years with a single Intramural leiomyoma size> 5 cm; Women with uterine myoma> 5cm with other myoma size <2cm
Exclusion criteria:
Other women with myoma size> 2cm; Women with uterine leiomyomas treated with estrogen or progesterone last month; Women with a history of major medical problems or previous medical or surgical treatment for leiomyomas; All women with leiomyoma sizes 2 to 5cm
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Road
City
Babol
Postal code
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
4232
Health conditions studied
1
Description of health condition studied
Symptomatic Uterine Leiomyoma
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
Leiomyoma tumors
Timepoint
On admission and on days 30 and 90 after treatment
Method of measurement
Ultrasound
2
Description
Uterine volume
Timepoint
On admission and on days 30 and 90 after treatment
Method of measurement
سونوگرافی
Secondary outcomes
1
Description
Serum gonadotropin
Timepoint
On admission and on days 30 and 90 after treatment
Method of measurement
Laboratory
2
Description
Serum Estradiol
Timepoint
On admission and on days 30 and 90 after treatment
Method of measurement
Laboratory
3
Description
Menstrual pattern
Timepoint
On admission and on days 30 and 90 after treatment
Method of measurement
clinical
4
Description
Clinical symptoms associated with leiomyoma
Timepoint
On admission and on days 30 and 90 after treatment
Method of measurement
clinical
Intervention groups
1
Description
Letrozole drug produced by the pharmaceutical company Soha the amount of 2.5mg / d is administered to patients for a period of twelve weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Ayatollah Rouhani
Full name of responsible person
Dr. Asieh Khodami
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research of Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
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 Babol 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
Hospital Ayatollah Rouhani
Full name of responsible person
Dr. Asieh Khodami
Position
Resident, Obstetrics and Gynecology
Other areas of specialty/work
Street address
Hospital Ayatollah Rouhani, Ganjafroz Road
City
Babol
Postal code
Phone
+98 11 1223 8284
Fax
Email
drhoseininejad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hospital Ayatollah Rouhani
Full name of responsible person
Dr. Shahnaz Barat
Position
Gynecologist
Other areas of specialty/work
Street address
Hospital Ayatollah Rouhani, Ganjafroz Road
City
Babol
Postal code
Phone
+98 11 1223 8284
Fax
Email
shahnaz_barat200@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Other areas of specialty/work
Street address
Hospital Fatemehzahra
City
Babol
Postal code
Phone
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)