The objective of this study is to compare the endocrine and metabolic effects of Metformin versus Pioglitazone in women with polycystic ovarian syndrome and menstrual disorder. We randomized 56 women aged 20-49 years old with polycystic ovary syndrome and menstural disorder either to receive Metformin, 500 mg, three times daily or Pioglitazone, 30 mg daily, for 3 months. Metabolic (F.B.S, Insulin, TG, cholesterol, LDL, HDL) and endocrine parameters (Testosterone, DHEAS) were evaluated before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008094179N3
Registration date:2010-09-04, 1389/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-04, 1389/06/13
Registrant information
Name
Karoon Shahebrahimi
Name of organization / entity
Kermanshah Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6303
Email address
k-shahebrahimi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2010-07-10, 1389/04/19
Expected recruitment end date
2011-03-18, 1389/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of metformin and pioglitazone in polycystic ovarian syndrome
Public title
Effects of metformin and pioglitazone in polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: High TSH with FT4 in normal range
Exclusion criteria: receiving Levothyroxine, glucocorticoids, aspirin, amiodaron, lipid lowering agents, OCP, dopamine antagonist eg. metoclopramide and domperidone in recent 6 months, diabetic patients, pregnant women, women in menopause ages, patients older than 60 years
Age
From 20 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Kermanshah University of Medical Sciences and Health Servises
Street address
Shahid Beheshti boulevard, Kermanshah
City
kermanshah
Postal code
Approval date
2010-06-15, 1389/03/25
Ethics committee reference number
205/420/7/پ
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Endocrine nutritional and metabolic diseases
Primary outcomes
1
Description
Blood pressure
Timepoint
3 months
Method of measurement
Barometers
2
Description
Fasting sugar serum level
Timepoint
3 months
Method of measurement
mg/dl
3
Description
Fasting Insulin serum level
Timepoint
3 months
Method of measurement
Uiu/ml
4
Description
Testostrone serum level
Timepoint
3 months
Method of measurement
ngr/dl
5
Description
DHEADS serum level
Timepoint
3 months
Method of measurement
ngr/dl
Secondary outcomes
1
Description
Cholesterol serum level
Timepoint
3 months
Method of measurement
mg/dl
2
Description
Triglyceride serum level
Timepoint
3 months
Method of measurement
mg/dl
3
Description
LDL serum level
Timepoint
3 months
Method of measurement
mg/dl
4
Description
HDL serum level
Timepoint
3 months
Method of measurement
mg/dl
Intervention groups
1
Description
Metformin 500 mg three times dialy, orally for 3 month.
Category
Treatment - Drugs
2
Description
Pioglitazone 30 mg dialy, orally for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr Nasrin Bazgir
Street address
City
kermanshah
2
Recruitment center
Name of recruitment center
Shafa clinic
Full name of responsible person
Dr Nasrin Jalilian
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Kermanshah University of Medical Science
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti boulevard, Kermanshah
City
Kermanshah
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, Kermanshah University of Medical Science
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Karoon Shahebrahimi
Position
Fellowship of adult's endocrine and metabolic disease
Other areas of specialty/work
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6303
Fax
+98 83 1427 6343
Email
dr_shahebrahimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Dr Karoon Shahebrahimi
Position
Fellowship of adult's endocrine and metabolic disease
Other areas of specialty/work
Street address
Sorkhelijeh.kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
dr_shahebrahimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Bazgir
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Emam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6300
Fax
+98 83 1427 6343
Email
drnasrinbazdar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)