Protocol summary

Summary
The purpose of this study is to determine and comparison of three treatments, Metformin, Flutamide incombination with oral contraceptives and Simvastatin, effects on metabolic complications of polycystic ovary syndrome. This study is a single blind, multicenter, clinical trial. The physician who is responsible for physical examination and clinical assessments will be blind about the therapeutic intervention of each patient. Subjects will be recruited from polycystic ovary syndrome and metabolic syndrome patients, which refer to midwifery clinic of Al-Zahra and Beheshti hospitals, Isfahan, Iran. Subjects, who will enter to study, are women of at least 18 years old, who are single. They should have no evidence of thyroid dysfunction, Cushing syndrome, hyperprolactinaemia and breast cancer. They also should consent to participate in trial, and normal kidney function, bilirubin level, and serum aminotransferases. After the inclusion, participants who have no desire to continue the study, get married, or faced to drug side effects will be excluded from study. Estimated sample size for the study is 111 subjects. Participants will be randomly assigned into three groups and each group will receive one of the therapeutic interventions. Participants will be undergone the treatment for 6 month. Subsequently, the effect of each therapeutic will be evaluated on insulin resistance, blood pressure, fasting blood sugar, lipid profiles and CRP.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405217513N10
Registration date: 2015-05-15, 1394/02/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-15, 1394/02/25
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Metformin, Flutamide + oral contraceptives and Simvastatin Effects on Metabolic complications of Polycystic Ovary Syndrome
Public title
Comparison of Metformin, Flutamide and Simvastatin Effects on Metabolic complications of Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age ≥ 18 years; being single; having no evidence for thyroid dysfunction, Cushing syndrome, and hyperprolactinaemia; to have normal kidney function, bilirubin level, and serum aminotransferases; none-smoker; not having breast cancer; not using any drug which probably affects the Ovarian function; insulin sensitivity and lipid profile; No contraindication to use drugs. Exclusion criteria: to refuse to continue the study; marriage; emerging side drugs effects or contraindication; not to comply the study protocol.
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 111
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences- Hezar jarib Ave. - Isfahan
City
Isfahan
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
394074

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
insulin resistance
Timepoint
baseline and after 6 month
Method of measurement
Homa-IR formula

2

Description
fasting blood sugar
Timepoint
baseline and after 6 month
Method of measurement
mg/dl

3

Description
C-reactive protein
Timepoint
baseline and after 6 month
Method of measurement
mg/liter

4

Description
blood pressure
Timepoint
baseline and after 6 month
Method of measurement
Blood pressure > 130/85 (mmHg)

Secondary outcomes

1

Description
BMI
Timepoint
baseline - after 6 month
Method of measurement
weight (kg)/ height square (m)

2

Description
waist circumference
Timepoint
baseline - after 6 month
Method of measurement
cm

Intervention groups

1

Description
1000mg Meformin per day
Category
Treatment - Drugs

2

Description
62.5mg Flutamid + low dose oral contraceptives ( OC ) per day
Category
Treatment - Drugs

3

Description
20mg Simvastatin per day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Street address
City
Isfahan

2

Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
research management
Street address
School of Medicine - Isfahan University of Medical Sciences - Hezar jarib Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
School of Medicine
Full name of responsible person
Mahboobe Mohamadkhani
Position
Resident
Other areas of specialty/work
Street address
School of Medicine in Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 913 319 8493
Fax
Email
mohamadkhani88m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi-Tehrani
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Medicine - Isfahan University of Medical Sciences - Hezar jarib Ave.
City
Isfahan
Postal code
Phone
+98 913 113 4081
Fax
Email
Tehrani@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical scienses
Full name of responsible person
Mahboobe Mohamakhani
Position
Resident
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
mohamadkhani88m@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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