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The effect of atorvastatin on biochemical and hemostatic profile of patients with polycystic ovary syndrome

Protocol summary

Summary
This study will be performed at the Research center for bone health -imam reza hospital tabriz.regarding previous we select 40 pts and using Rand List software divide them into two groups.In the first group Atorvastatin(Razak com.)20 Mg daily and in the second group OCP are given. weight, abd.circumference, BMI. biochemical markers including FPG, serum insulin, hsCRP, LDL, HDL, Tg, Cholesterol, LH, Fibrinogen, testosteron , DHEAS and homocystein before and after 3 months of prescribing the above drugs . Results will be analysed using SPSS 16 software .To compare qualitative variables we will use chi-square and to compare quantitative variables we will use Independant sample t test and repeated measure of Annova. Level if significance is 0.05.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208299626N1
Registration date: 2012-08-29, 1391/06/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-29, 1391/06/08
Registrant information
Name
Majid Mobaseri
Name of organization / entity
Tabriz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
t.u.end.d@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research, Tabtiz University of Medical Sciences
Expected recruitment start date
2012-04-04, 1391/01/16
Expected recruitment end date
2013-04-05, 1392/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of atorvastatin on biochemical and hemostatic profile of patients with polycystic ovary syndrome
Public title
The effect of atorvastatin on biochemical and hemostatic profile of patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteriion: all patients with PCOS. Exclusion criteria: any disease in recent month; ingestion of any drug that might affect insulin level, lipids and ovary function in recent 6 months; previous statin use; any chanfe in lifestyle during study; pregnancy and lactation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Faculty of Medicine- Daneshgah Ave. Tabriz
City
Tabriz
Postal code
Approval date
2012-04-04, 1391/01/16
Ethics committee reference number
9139

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
Biochemical and Hemostatic profile
Timepoint
Three month
Method of measurement
Paraclinical

Secondary outcomes

1

Description
Alternation in biochemical and hemostatic profile
Timepoint
Three month
Method of measurement
Paraclinical

Intervention groups

1

Description
Atrovastatin in case group
Category
Treatment - Drugs

2

Description
OCP in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bone disease health center
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rashidi
Street address
Medicine faculty- Daneshgah ave- Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Majid Mobaseri
Position
Associate profeesor- endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
mobasserimajid@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Majid Mobaseri
Position
Associate professor- Endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
mobasserimajid@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Jafar Shadi
Position
MD, Fellowship of Endocrinology
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz
City
tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
jafar_shadi30@yahoo.com
Web page address

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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