Protocol summary

Summary
This study will a randomized clinical trial to compare the effectiveness of metformin and pioglitazone in treatment of women with polycystic ovary syndrome (PCO). Inclusion criteria: age between 18 to 40 years old; diagnosed PCOS by AES (Androgen excess soiciety2006) criteria include: 1. Oligo or anovulation 2. Clinical or biochemical hyperandrogenism and rejection any other reasen cause to hyperandrogenism. Exclusion criteria: pregnancy and lactation; impaired liver and renal function tests; thyroid disorder; hyperprolactinemia; adrenal disorders; patient on estrogen and progesterone pills; the presence of type 1 and type 2 diabetes mellitus; late-onset congenital adrenal hyperplasia, and Cushing’s syndrome; none of the women had been taking clomiphene citrate, oral contraceptives, antiandrogens, insulin, minoxidil, phenytoin, cyclosporine, or drugs to control their appetite, lipid profile, during the previous 3 months and any severe systemic disease. Seventy five women with PCOS aged 18-40 years old will be randomly allocated to one of the three treatment groups. Metformin group (25) will treat with metformin mono-therapy (1500mg daily) ; ; metformin plus pioglitazone group (25) will treat with metformin(1500mg daily) plus pioglitazone(30mg daily) and pioglitazone group(25) will treat with pioglitazone mono –therapy(30mg daily) for 3 months. Treatment will be discontinued once pregnancy will diagnose. All patients undergo clinical and biochemical evaluation and analyses involving the pre- and post-intervention fasting blood sugar (FBS), lipid profiles, body mass index (BMI), serum insulin, the homeostatic model assessment of insulin resistance (HOMA-IR), triglyceride, lower density cholesterol, high density cholesterol and DHEAS (dehydroepiandrosterone sulphate) LH/FSH,Total Testosterone،17-OHP, (17hydroxyprogestrone) waist to hip ratio in three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403101836N7
Registration date: 2014-04-15, 1393/01/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-15, 1393/01/26
Registrant information
Name
Seyed Mojtaba Sohrevardi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5001
Email address
smsohrevardi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metformin and pioglitazone in women with polycystic ovary syndrome
Public title
Evaluation of effectiveness of Metformin and pioglitazone in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 40 years old; diagnosed PCOS by AES (Androgen excess soiciety2006) criteria include: 1. Oligo or anovulation 2. Clinical or biochemical hyperandrogenism and rejection any other reasen cause to hyperandrogenism. Exclusion criteria: pregnancy and lactation; impaired liver and renal function tests; thyroid disorder; hyperprolactinemia; adrenal disorders; patient on estrogen and progesterone pills; the presence of type 1 and type 2 diabetes mellitus; late-onset congenital adrenal hyperplasia, and Cushing’s syndrome; none of the women had been taking clomiphene citrate, oral contraceptives, antiandrogens, insulin, minoxidil, phenytoin, cyclosporine, or drugs to control their appetite, lipid profile, during the previous 3 months and any severe systemic disease.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
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
Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
City
Yazd
Postal code
Approval date
2014-03-09, 1392/12/18
Ethics committee reference number
248671 /17/1/پ

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
serum Insulin level
Timepoint
before intervention and after intervention( after three month)
Method of measurement
mili IU per liter

2

Description
low density lipoprotein
Timepoint
before intervention and after intervention( after three month)
Method of measurement
mili gram per deciliter

3

Description
high density lipoprotein
Timepoint
before intervention and after intervention( after three month)
Method of measurement
mili gram per deciliter

4

Description
triglyceride
Timepoint
before intervention and after intervention( after three month)
Method of measurement
mililgram per deciliter

5

Description
fast blood suger
Timepoint
before intervention and after intervention ( after three month)
Method of measurement
milligram per deciliter

6

Description
dehydroepiandrosterone sulphate
Timepoint
before intervention and after intervention( after three month)
Method of measurement
milligram per liter

7

Description
17hydroxyprogestrone
Timepoint
before intervention and after intervention( after three month)
Method of measurement
microgram per liter

8

Description
Total Testosterone
Timepoint
before intervention and after intervention( after three month)
Method of measurement
microgram per liter

9

Description
LH/FSH ratio
Timepoint
before intervention and after intervention( after three month)
Method of measurement
IU per liter

10

Description
Cholesterol
Timepoint
before intervention and after intervention( after three month)
Method of measurement
milligram per deciliter

Secondary outcomes

1

Description
waist to hip ratio
Timepoint
before intervention and after intervention after three month
Method of measurement
meter

2

Description
Body Mass Index
Timepoint
before intervention and after intervention after three month
Method of measurement
kilogram per square meter

3

Description
side effect of dugs
Timepoint
afer intervention (after three month)
Method of measurement
descriptive

4

Description
Homeostatic Model Assessment-Insulin Resistance) HOMA -IR)
Timepoint
before intervention and after intervention( after three month)
Method of measurement
milli IU per deciliter /milli gram per deciliter

Intervention groups

1

Description
group number 1 (25 patient) metformin 500 mg three times a day (first week 500 mg daily then second week 500 mg two times a day and third week 500 mg three times a day and continuous with 500 mg three times a day for three month)
Category
Treatment - Drugs

2

Description
group number 2 (25 patient ) tab pioglitazone 30 mg daily for three month
Category
Treatment - Drugs

3

Description
group number3 (25 patient) tab metformin 500 mg three times a day (first week 500 mg daily then second week 500 mg two times a day and third week 500 mg three times a day and continuous with 500 mg three times a day for three month ) and tab pioglitazone 30 mg daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi hospital-khatamol anbiya clinic
Full name of responsible person
Dr seyed mojtaba sohrevardi
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ezoddini Ardakani
Street address
Research Department, Building No 2, Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
YYazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Seyed Mojtaba Sohrevardi
Position
PhD of clinical pharmacy/ research assistant of yazd faculty of pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
City
Yazd
Postal code
Phone
+98 35 1820 3419
Fax
Email
smsohrevardi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Seyed Mojtaba Sohrevardi
Position
PhD of clinical pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
City
Yazd
Postal code
Phone
+98 35 1820 3419
Fax
Email
smsohrevardi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Seyed Mojtaba Sohrevardi
Position
PhD of clinical pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
City
Yazd
Postal code
Phone
+98 35 1820 3419
Fax
Email
smsohrevardi@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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