Protocol summary

Summary
Objectives: This study aimed to compare the medical effects of raloxifene and GnRH on uterine lyomioma size. Design: 53 women with uterine lyomioma were participated in this study. Setting and conduct: This was a randomized controlled trial that it was conducted in Besat hospital in Sanandaj-Iran. Participants were randomly divided into two groups of Raloxifene and GnRH using simple randomization (using computer). 27 patients were allocated inraloxifene group and 26 patients were allocated in GnRH group. Participants and inclusion and exclusion criteria: 61 patients were evaluated in the first step. Then 53 patient were entered to the study. Inclusion criteria included not being menopausal, and having lyomiomas with a minimum size of 40 mm and a maximum of 60 mm in one of the diameters of tumor. Exclusion criteria included having metabolic disease, neoplasia disease, infectious diseases, blood disorders, history of venous thrombosis, liver disease, active rheumatoid arthritis, BMI greater than 30 or less than 18 kg/m2, hormone therapy in the last 6 months, surgery in the last 6 months, hypoechoic or calcified lyomiomas, endometrial abnormalities in sonography, and lesions of the cervix. Interventions: GnRH group received one dose of GnRH per month (3.75mg intramuscular injection) and raloxifene group received a daily dose of raloxifene 60 mg/orally for 3 months. Main outcome variables: The size of lyomioma, prior and during the intervention, was determined by a sonographist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014032816490N2
Registration date: 2014-04-13, 1393/01/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-13, 1393/01/24
Registrant information
Name
Ebrahim Ghaderi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1613 1366
Email address
ebrahimghaderi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-11-06, 1389/08/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of GnRH and Raloxifen on the size of uterine lyomioma
Public title
Effects of GnRH and Raloxifen on the size of uterine lyomioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: not being menopausal, and having a history of lyomiomas with a minimum size of 40 mm and a maximum of 60 mm in one of the diameters of tumor. Exclusion criteria: having metabolic disease, neoplasia disease, infectious diseases, blood disorders; history of venous thrombosis, liver disease, active rheumatoid arthritis; BMI greater than 30 or less than 18 kg/m2; hormone therapy in the last 6 months; surgery in the last 6 months; hypoechoic or calcified lyomiomas; endometrial abnormalities in sonography, and lesions of the cervix.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 53
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
Ethics committee of Kurdistan University of Medical Sciences
Street address
Vice chancellor for research, Medicine School, Pasdaran Ave
City
Sanandaj
Postal code
6617713446
Approval date
2010-10-24, 1389/08/02
Ethics committee reference number
89/43/پ

Health conditions studied

1

Description of health condition studied
Uterine lyomioma
ICD-10 code
N85.9
ICD-10 code description
Noninflammatory disorder of uterus, unspecified

Primary outcomes

1

Description
Uterine leiomyomas size
Timepoint
Before and 90 days after treatment
Method of measurement
Sonography

Secondary outcomes

1

Description
Endometrial thickness
Timepoint
Before and 90 days after treatment
Method of measurement
Sonography

Intervention groups

1

Description
The intervention group 2 was consisted of 26 patients; they were treated using GnRH one dose per month (3.75mg intramuscular injection).
Category
Treatment - Drugs

2

Description
Intervention group 1 was consisted of 27 patients who were received a daily dose of raloxifene 60 mg/orally for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Farnaz Zandvakili
Street address
Department of Gynecology, Keshavarz Ave, Besat Hospital
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heidari
Street address
Vice chancellor for research, Medicine School, Pasdaran Ave
City
Sanandaj
Grant name
طرح غیر HSR
Grant code / Reference number
1389/43
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Farhadifar
Position
Associated Professor
Other areas of specialty/work
Street address
Department of Gynecology, Besat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
6619667761
Phone
+98 87 1613 1366
Fax
+98 87 1328 5890
Email
fariba.farhadifar@muk.ac.ir
Web page address
http://www.muk.ac.ir/Muk/Hospitals/BesatHospital.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Farnaz Zandvakili
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Gynecology, Besat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
6619667761
Phone
+98 87 1613 1366
Fax
+98 87 1328 5890
Email
dr.fzandvakili@gmail.com
Web page address
http://www.muk.ac.ir/Muk/Hospitals/BesatHospital.aspx

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Farhadifar
Position
Associated Professor
Other areas of specialty/work
Street address
Department of Gynecology, Besat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
6619667761
Phone
+98 87 1613 1366
Fax
+98 87 1328 5890
Email
fariba.farhadifar@muk.ac.ir
Web page address
http://www.muk.ac.ir/Muk/Hospitals/BesatHospital.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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