Protocol summary

Summary
This study is a controlled, randomized and single-blind clinical trial that is performed on 44 patients with polycystic ovaries between 16 and 45 years old and Body Mass Index more than 25. Patients who are diabetic, hypothyroidism, nonclassic congenital adrenal hyperplasia or prolactinoma will be excluded. All of the patients should signed informed consent for taking either Bromocriptin or placebo; but, they will not be aware which group of study (experimental or control) have been entered. Patients participating in this research, randomly select a numbered card in sealed envelopes in order to enter the control or the experimental group. Giving the medication and randomization process are done by researcher, accordingly, this study is single-blind. At the beginning of the study, fasting blood sugar and fasting insulin are measured as a basis to the prescription of medication or placebo in both groups. Measurement of fasting blood sugar and fasting insulin are done through Glucose Oxidase and Chemiluminescence methods, respectively. Then the main group is given 2.5 milligram of Bromocriptin once daily for 8 days to be taken after meal.The control group is given placebo tablets similar to Bromocriptin once daily for 8 days. Placebo is similar to that of Bromocriptin tablets in terms of shape, colour and flavor. Its components include: micro-crystalline cellulose, lactose, starch, sorbitol and magnesium stearate. To control the correct use of medications, pills and placebos are given to patients and at the end of study, the empty blisters of pills are collected and controlled. If a patient has severe nausea and vomiting, she will be excluded from study. Upon completion of study period (8 days), fasting blood sugar and fasting insulin are measured again, in both groups, using the above mentioned methods. Finally the collected data will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013030412699N1
Registration date: 2014-01-24, 1392/11/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-24, 1392/11/04
Registrant information
Name
Zivar Shirinpour
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3013
Email address
shirinpour.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences.
Expected recruitment start date
2013-02-07, 1391/11/19
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Bromocriptin on insulin resistance in comparison with placebo in patients with polycystic ovaries referring to Golestan Hospital of Ahvaz.
Public title
Effect of Bromocriptin in treatment of patients with polycystic ovaries.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with polycystic ovaries between 16 and 45 years old and Body Mass Index (BMI) more than 25. Exclusion criteria: Fasting blood sugar more than 126, hypothyroidism, prolactinoma, nonclassic congenital adrenal hyperplasia, psychosis, breast feeding, syncope attack, severe nausea and vomiting.
Age
From 16 years old to 45 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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Vice Chancellery for Development, Research and Technology of Ahvaz Jondishapour
Street address
Vice Chancellery for Development, Research and Technology of Ahvaz Jondishapour University of Medical Sciences, University city, Golestan St.
City
Ahvaz
Postal code
6135733118
Approval date
2013-02-23, 1391/12/05
Ethics committee reference number
ETH695

Health conditions studied

1

Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Stein Leventhal Syndrome

Primary outcomes

1

Description
Blood Sugar
Timepoint
Before intervention and 8 days after intervention
Method of measurement
mg /dl with Glucose Oxidase method

2

Description
Fasting Insulin
Timepoint
Before intervention and 8 days after intervention
Method of measurement
micIU/ml, with chemiluminescence method

Secondary outcomes

1

Description
Dizziness
Timepoint
Before intervention and daily during intervention
Method of measurement
Asking from patients

2

Description
Nausea and vomiting
Timepoint
Before intervention and daily during intervention
Method of measurement
Asking from patients

Intervention groups

1

Description
Intervention Group: Bromocriptin with trade name cyclocet, made by Iran Hormone-Tehran company, gives once daily per oral for 8 days.
Category
Treatment - Drugs

2

Description
Control Group: Placebo as 2.5 milligram tablet, once daily per oral for 8 days. Placebo is made from micro-crystalline cellulose, lactose, starch,sorbitol and magnesium stearate which made in pharmacology school of Ahvaz Jondishapour University of Medical Sciences.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology clinic of Golestan Hospital
Full name of responsible person
Zivar Shirinpour, Fellowship of Endocrinology
Street address
Endocrinology clinic , Golestan Hospital , Golestan St.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Development, Research and Technology of Ahvaz Jondishapour University of Medical
Full name of responsible person
Mostafa Feghhi
Street address
Vice Chancellor for Development, Research and Technology of Ahvaz Jondishapour University of Medical Sciences, University city, Golestan St.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Development, Research and Technology of Ahvaz Jondishapour University of Medical
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
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Homeira Rashidi
Position
Associated professor of Endocrinology
Other areas of specialty/work
Street address
Endocrinology ward, Golestan Hospital, Golestan St.
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3013
Fax
+98 61 1374 3030
Email
Golestanhospital@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Zivar Shirinpour
Position
Fellowship of Endocrinology
Other areas of specialty/work
Street address
Endocrinology ward, Golestan Hospital, Golestan St.
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3013
Fax
+98 61 1374 3030
Email
Golestanhospital@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Seyed Bahman Ghaderian
Position
Associated professor of Endocrinology
Other areas of specialty/work
Street address
Endocrinology ward, Golestan Hospital, Golestan St.
City
Ahvaz
Postal code
6135733118
Phone
+98 61 1374 3013
Fax
+98 61 1374 3030
Email
Golestanhospital@ajums.ac.ir
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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