Protocol summary

Summary
Metformin and rosiglitazone both are used to treat polycystic ovary syndrome. In this study we aimed to compare the effects of these two drugs to treat this syndrome. To do so we are going to select 44 patients who suffer from polycystic ovary syndrome that refer to Al-Zahra or Shahid Beheshti hospitals and meet inclusion criteria. Then we randomly assign them into two groups. All patients will be followed without any treatment for six weeks, and then each patient will use metformin or rosiglitazone alone for 12 weeks. After this phase, all patients will use the combination of two drugs. All patients will undergo sonography, endometrial biopsy and laboratory tests before drug use, 12 weeks after beginning the drug and 12 weeks after using combination of two drugs. Some inclusion criteria include: age between 18-40 years, not consumption of drugs which change sexual hormones metabolism for at least 1 month before trial, not using contraceptive pills for at least 3 months before the trial. In the case of pregnancy, anemia, type 2 diabetics, hyperprolactinemia and any disorder in liver or kidney functions patient will be excluded from the study. The size of ovary, endometrium density, blood sugar, body mass index and hirsutism will be determined for all patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201605257513N12
Registration date: 2016-07-22, 1395/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-22, 1395/05/01
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
Vice chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of the effect of metformin and rosiglitazone alone and in combination on ovarian and endometrium among polycystic ovarian syndrome patients
Public title
Comparison the effect of Metformin and Rosiglitazone, alone and in combination, to treat polycystic ovary syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: females between 18-40 years old; euthyroid; non smoker; normal physical condition; not consumption of drugs that change sexual hormones metabolism for at least 1 month before trial; not using contraceptive pills for at least 3 months before the trial. Exclusion criteria: classic 21_hydroxilase deficiency; hyperprolactinemia; androgen producing tumor; pregnancy; impaired liver tests or kidney function disorder; type 2 Diabetes; anemia; thrombocytopenia; explicit hypertension.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Since the list of patients is available, 44 patients of these two centers will be selected by simple random sampling method. Then the name of each patient will be separately written on a card, and 22 cards will be chosen randomly. These patients will receive the first intervention and those remaining patients will be assigned into second intervention.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Av.
City
Isfahan
Postal code
Approval date
2014-04-16, 1393/01/27
Ethics committee reference number
394050

Health conditions studied

1

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

Primary outcomes

1

Description
Ovarian size
Timepoint
At the beginning of the study, after one-drug usage period, after the period of treatment with combination of two drugs
Method of measurement
Trans vaginal sonography

2

Description
Endometrium density
Timepoint
At the beginning of the study, after one-drug usage period, after the period of treatment with combination of two drugs
Method of measurement
Trans vaginal sonography

Secondary outcomes

1

Description
Blood sugar
Timepoint
At the beginning of the study, after one-drug usage period, after the period of treatment with combination of two drugs
Method of measurement
Laboratory tests

2

Description
Hirsutism
Timepoint
At the beginning of the study, after one-drug usage period, after the period of treatment with combination of two drugs
Method of measurement
Ferriman criteria

3

Description
BMI
Timepoint
At the beginning of the study, after one-drug usage period, after the period of treatment with combination of two drugs
Method of measurement
Division of weight to squared hieght

Intervention groups

1

Description
Metformin intervention group: Patients well be followed without any drug for the first 6 weeks. Then they will receive metformin alone for 12 weeks. After that they will receive the combination of metformin and rosiglitasone for 12 weeks.
Category
Treatment - Drugs

2

Description
Rosiglitazone intervention group: Patients well be followed without any drug for the first 6 weeks. Then they will receive rosiglitazone alone for 12 weeks. After that they will receive the combination of metformin and rosiglitasone for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gynecology clinic of Al-Zahra hospital
Full name of responsible person
Maryam Hoseini Roozbahani
Street address
Al-Zahra University Hospital, Sofe Blvd, Keshvari Highway
City
Isfahan

2

Recruitment center
Name of recruitment center
Gynecology clinic of Shahid Beheshti hospital
Full name of responsible person
Maryam Hoseini Roozbahani
Street address
Shahid Beheshti hospital, Beside Felezi bridge, Matahari Av.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancelor of research of Isfahan University of Medical Sciences
Full name of responsible person
Mrs.Daneshvar
Street address
Vice chancellor of research, Isfahan University of Medical Sciences, Hezar jarib Av.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancelor of research of 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ferdos Mebrabian
Position
Associate professor of Gynecology
Other areas of specialty/work
Street address
Isfahan University of MEdical Sciences, Hezarjarib Av.
City
Isfahan
Postal code
Phone
+98 31 3669 2277
Fax
Email
Maryam.roozbahan.77@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Hoseini Roozbahani
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib Av.
City
Isfahan
Postal code
Phone
+98 31 3669 2277
Fax
Email
Maryam.roozbahani.77@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Hoseini Roozbahani
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib Av.
City
Isfahan
Postal code
Phone
+98 31 3669 2277
Fax
Email
Maryam.roozbahani.77@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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