Protocol summary

Summary
Eighty overweight obese women with PCOs were enrolled in the study according to inclusion and exclusion critical. A physical examination, focusing on anthropometry and hirsutism evaluation, was performed at base line. These Lab test were asked for them: FBS, SHBG, Total testosterone, free Total Cholesterol, TG, HDL, LDL, DHEAS, testosterone, fasting Insulin and OGTT. Women were placed on a hypocaloric diet C1200-1400 Kcal/daily containing 50% carbohydrates, 30% Lipids and 20% Proteins. They were advised to have contraception and after one month they were visited and randomly placed on 4 groups: placebo (n=20), Metformin (500 mg/TDS, n=20), Flutamide (250 mg/BID, n=20) and both Metformin and Flutamide. They were regularly checked at monthly intervals to evaluate compliance with both dietary and pharmacological treatment, and side–effects. If having no problem, each woman took her intervention for 1-month again. At the end of third month LFI and renal function test were done. At the end of 6th month, physical examination focusing on anthropometry and hirsutism were done and all first labs were asked.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138807271760N3
Registration date: 2010-05-21, 1389/02/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Expected recruitment start date
2008-05-21, 1387/03/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Flutamide and Metformin administered in dieting overweight-obese women with polycystic ovary syndrome
Public title
Effect of Flutamide and Metformin administered in dieting overweight-obese women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Reproductive age (range 18-45 yr), body mass index (BMI) at least 28 kg/m2, and waist circumference at least 88 cm, chronic an ovulation severe oligomorrhea or amenorrhea, hirsutism (Ferriman – Gallwey score 8), total testosterone levels at least 0.72 ng/ml and polycystic ovarian morphology at ultrasound. Exclusion criteria: Use of any medication or a significant modification in body weight within the previous 3 months or dieting, hyperprolactinemia, cushing’s syndrome, late–onset congenital adrenal hyperplasia, thyroid dysfunction, diabetes, cardiovascular, renal or Liver diseases, positive pregnancy test.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethics committee of Babol University of Medical sciences
Street address
Gangafroz Avenue
City
Babol
Postal code
Approval date
2010-02-27, 1388/12/08
Ethics committee reference number
1009

Health conditions studied

1

Description of health condition studied
Polycistic overian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycistic overian syndrome

Primary outcomes

1

Description
Anthropometric measurement
Timepoint
monthly
Method of measurement
physical examination

Secondary outcomes

1

Description
serum Lipid
Timepoint
monthly
Method of measurement
Lab

2

Description
serum glucose
Timepoint
monthly
Method of measurement
lab

3

Description
fasting insulin
Timepoint
6 months
Method of measurement
lab

4

Description
testosteroe, OHEA, SHBG
Timepoint
6 months
Method of measurement
lab

5

Description
hirsotism
Timepoint
6 months
Method of measurement
physical examination

Intervention groups

1

Description
Flutamide and/or Metformin
Category
Treatment - Drugs

2

Description
Hypocaloric dieting
Category
Lifestyle

3

Description
Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemehzahra Fertility & infertility hospital
Full name of responsible person
Seddigheh Esmaeilzadeh
Street address
Noshirvani street
City
Babol

2

Recruitment center
Name of recruitment center
Yahyanejad hospital
Full name of responsible person
Dr. Seddigheh Esmaeilzadeh
Street address
Farhang cross
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Gangafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol 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
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center - noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Seddigheh Esmaeilzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
sesmael@yahoo.com
Web page address

Person responsible for updating data

Contact

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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