Protocol summary

Summary
Objective: To investigate the adjuvant cabergoline therapy effects on menstrual irregularity and androgen system in polycystic ovary syndrome women with hyperprolactinemia. Materials and methods: This randomized clinical trial was done on 110 PCOS women with increased serum prolactin concentration [1.5 ford more than normal level (>37.5ng/ml)].Participants were divided into two groups: Case group (n=55) treated with metformin 1gr/day and cabergoline 0.5 mg/week for 4 months and control group (n=55) treated with metformin 1g/day and placebo weekly. Testosterone, prolactin, and DHEAS level were measured before and four months after intervention in two groups. Also, situation of menstrual cycles asked and recorded before and after intervention. Inclusion criteria:110 PCOS women with increased serum prolactin concentration [1.5 ford more than normal level (>37.5ng/ml)], who referred to endocrinology clinic of Khatamal Anbiaa Cilinic, Shahid Sadoughi University of Medical Sciences, were examined for other causes of increased prolactin levels such as TSH test, hypophis MRI for detection of prolactinema and other disorders or tumors that can increase prolactin, and then women who had diagnosed as PCOS according to the latest AES standards enrolled in the study. Exclusion criteria: Patients who had other endocrine disorders (such as thyroid disorders), history of cardiovascular disease, history of using the increasing prolactin drugs, women who wanted to be pregnant, and who couldn’t tolerate the cabergoline were excluded from the study. Primary outcome measure: Menstrual irregularity, and laboratory findings (serum testosterone, DHEAS and prolactin). Secondary outcome measure: Weight

General information

Acronym
Cabergoline in PCOS women
IRCT registration information
IRCT registration number: IRCT2014121420086N2
Registration date: 2015-01-08, 1393/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Parisa Khani
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 8348
Email address
pkhani55@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cabergoline plus metformin therapy effects on menstrual irregularity and androgen system in polycystic ovary syndrome women with hyperprolactinaemia
Public title
Effect of cabergoline on laboratory findings and menstural irregularity in PCOS women
Purpose
Treatment
Inclusion/Exclusion criteria
110 PCOS women with increased serum prolactin concentration [1.5 fold more than normal level (>37.5ng/ml)]; between 18-35 years old, who referred to endocrinology clinic of Khatamal Anbiaa Cilinic, Shahid Sadoughi University of Medical Sciences, were examined for other causes of increased prolactin levels such as TSH test, hypophis MRI for detection of prolactinema and other disorders or tumors that can increase prolactin, and then women who had diagnosed as PCOS according to the latest AES standards enrolled in the study. Patients who had other endocrine disorders (such as thyroid disorders), history of cardiovascular disease, history of using the increasing prolactin drugs, women who wanted to be pregnant, and who couldn’t tolerate the cabergoline were excluded from the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Shahid Sadoughi University of Medical Sciences- Bahonar sq- Yazd
City
Yazd
Postal code
8915173149
Approval date
2012-06-17, 1391/03/28
Ethics committee reference number
41511/1/17/پ

Health conditions studied

1

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

Primary outcomes

1

Description
menstural irregularity
Timepoint
at the beggining of study and 4 months after intervention
Method of measurement
standard questionniare

2

Description
Serum testosteron
Timepoint
at the beggining of study and 4 months after intervention
Method of measurement
enzyme-linked radio immune sorbent assay (ELISA)

3

Description
Serum DHEAS
Timepoint
at the beggining of study and 4 months after intervention
Method of measurement
enzyme-linked radio immune sorbent assay (ELISA)

4

Description
Serum prolactin
Timepoint
at the beggining of study and 4 months after intervention
Method of measurement
enzyme-linked radio immune sorbent assay (ELISA)

Secondary outcomes

1

Description
Weight
Timepoint
at the beggining of study and 4 months after intervention
Method of measurement
With SECA scale per kilogram

Intervention groups

1

Description
In case group metformin 1000 mg/day Cabergoline, 0.5 ml tablet one/week for 4 months was given.
Category
Treatment - Drugs

2

Description
In control group metformin 1000 mg/day and cabergoline pelacebo weekly for 4 months were given.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid sdoughi university of medical sciences- Khatamal Anbiaa Cilinic
Full name of responsible person
Akram Jowkar
Street address
Shahid sadoughi hospital- Endicrine department
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid sdoughi university of medical sciences
Full name of responsible person
Dr. Amirhooshang Mehrparvar
Street address
Shahid sadoughi hospital
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid sdoughi 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
Shahid sdoughi university of medical sciences
Full name of responsible person
Dr.Akram Jowkar
Position
endocrinologist
Other areas of specialty/work
Street address
Shahid sdoughi hospital-Department of Endocrinology
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
akjowkar@gmail .com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid sdoughi university
Full name of responsible person
Dr.Akram Jowkar
Position
Endocrinologist
Other areas of specialty/work
Street address
Shahid sdoughi hospital-Department of Endocrinology
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
akjowkar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
endocrinology department-Shahid sdoughi University of medical sciences
Full name of responsible person
Dr.Akram Jowkar
Position
Endocrinologist
Other areas of specialty/work
Street address
Shahid sdoughi hospital-Department of Endocrinology
City
Yazd
Postal code
Phone
00
Fax
Email
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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