The purpose of the study is to compare the therapeutic effects of metformin and simvastatin in Polycystic Ovarian Syndrome. A total of 60 women referred to Alzahra hospital of Tabriz who are in reproductive age and have PCOS will be recruited and assigned to receive metformine (1500 mg daily) or simvastatin (20 mg daily) for 3 months. Improvements in menstrual regularity and hyperandrogenic state and clinical and laboratory parameters will be measured before and 3 months after the interventions and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012285487N2
Registration date:2011-02-24, 1389/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-24, 1389/12/05
Registrant information
Name
Shabnam Pourabolghasem
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1442 1471
Email address
pourabolghasemsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Alzahra hospital
Expected recruitment start date
2010-10-07, 1389/07/15
Expected recruitment end date
2011-01-05, 1389/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of metformin and simvastatin in PCOS
Public title
Comparison of therapeutic effects of metformin and simvastatin in PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 40 years, having PCOS means: A - clinical symptoms and / or biochemical parameters of hyperandrogenism + irregular mens, having normal levels of bilirubin, creatinine , BUN, SGOT , SGPT , TSH
Exclusion criteria: Presence of congenital adrenal hyperplasia, hyperprolactinemia, Cushing's syndrome, androgen secreted by tumors, thyroid disease, diabetes mellitus, hypertension, history of cardiovascular disease, Using OCP and other steroid hormones or any drugs affecting ovarian function, insulin sensitivity or lipid profiles, Pregnancy, incidence of any adverse effects (liver and renal function tests elevation) during treatment
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for Research, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Postal code
Approval date
2010-09-27, 1389/07/05
Ethics committee reference number
5/4/4889
Health conditions studied
1
Description of health condition studied
PCOS
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
BP
Timepoint
Before clinical trial and three months after
Method of measurement
MmHg by using a mercury manometer
2
Description
Weight
Timepoint
Before clinical trial and three months after
Method of measurement
By Digital Scale
3
Description
BMI
Timepoint
Before clinical trial and three months after
Method of measurement
Weight to kilograms / the square of height in meters
4
Description
Hirsutism
Timepoint
Before clinical trial and three months after
Method of measurement
Hirsutism score
5
Description
Acne
Timepoint
Before clinical trial and three months after
Method of measurement
Clinical Finding
6
Description
Irregular Mens
Timepoint
Before clinical trial and three months after
Method of measurement
Clinical Finding
7
Description
Prolactin
Timepoint
Before clinical trial and 3 months after
Method of measurement
Laboratory results
8
Description
GTT
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
9
Description
FSH
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
10
Description
LH
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
11
Description
Total testosterone
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
12
Description
Free testosterone
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
13
Description
SHBG
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
14
Description
DHEAS
Timepoint
Before clinical trial and 3 months after
Method of measurement
Laboratory results
15
Description
Serum Insulin
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
16
Description
Insulin sensitivity Index
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
17
Description
Triglycerides
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
18
Description
Total cholesterol
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
19
Description
HDL, LDL
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
20
Description
CRP
Timepoint
Before clinical trial and three months after
Method of measurement
Laboratory results
Secondary outcomes
empty
Intervention groups
1
Description
Metformin, 1500 mg daily, orally for 3 months
Category
Treatment - Drugs
2
Description
Simvastatin, 20 mg daily, orally for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Fatemeh Kazemivand
Street address
Baghshomal Square - South Artesh Avenue.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alzahra Hospital Research Center
Full name of responsible person
Dr. Fatemeh Kazemivand
Street address
Baghshomal Square - South Artesh Avenue.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alzahra Hospital Research Center
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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Kazemivand
Position
Obstetrics and gynecology resident
Other areas of specialty/work
Street address
Baghshomal Sqaure - South Artesh Avenue
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
fatemehkazemivand@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shabnam Pourabolghasem
Position
Gynecologist
Other areas of specialty/work
Street address
Alzahra Hospital - South Artesh Avenue
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
pourabolghasemsh@tbzmed.ac.irsh_pour_gm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Health Sciences
Full name of responsible person
Pourablghasem-Shabnam
Position
Associate Professor of gynecology
Other areas of specialty/work
Street address
Alzahra hospital - South Artesh- Tabriz - Iran
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
pourabolghasemsh@tbzmed.ac.irsh_pour_gm@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)