Comparison of phlebothomy and Cyproterone compound in insulin resistance, antimullerian hormone(AMH) and prostatic specific antigen(PSA) in polycystic ovarian syndrome patients
Comparing the effect of Phlebotomy and Cyproterone Compound on insulin resistance, anti-mullerian hormone, and Prostatic Specific Antigen (PSA) concentrations in patients with Polycystic Ovary Syndrome (PCOS), A cross over study.
After excluding cases with diabetes mellitus, Iron deficiency anemia, pregnancy, cardiovascular disease, hypertension, thyroid disorders and cancer, One hundred and twenty subjects with PCOS aged 18-45 years, referred to Reproductive Endocrinology Research Center are screened with CBC, Ferritin and 75 gram Oral Glucose Tolerance Test (OGTT), to be enrolled for the study and after comprehensive evaluation and completion of questionnaires, participants are randomized into two groups: phlebotomy and Cyproterone Compound.
In the phlebotomy group 450 ml of whole blood is taken and in the second group, Cyproterone compound are administrated for three cycles.
After three months, participants are re-evaluated and second blood sample for hormonal assays are taken, after six weeks of washout period, two groups are interchanged (i.e., Cyproterone Compound to phlebotomy and vice versa).
After three months, clinical and biochemical assessments are repeated and at the end of six months, any changes of clinical manifestations and or biochemical findings, will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013080514277N1
Registration date:2014-06-16, 1393/03/26
Registration timing:prospective
Last update:
Update count:1
Registration date
2014-06-16, 1393/03/26
Registrant information
Name
Hayedeh Abtahi
Name of organization / entity
Research Institute for Endocrine Science Shaheed Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
habtahii@gmail.com
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of phlebothomy and Cyproterone compound in insulin resistance, antimullerian hormone(AMH) and prostatic specific antigen(PSA) in polycystic ovarian syndrome patients
Public title
Phelebothomy in polycystic ovarian syndrome (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PCOS pateints with:
18-45 years old; Hgb more than 12;
ferritine more than 20; no diabetes melitus
; no heart problem; no hypertention or under treatment; not pregnant;no thyroid problem; no cancer.
Exclusion criteria: pregnancy; heart or thyroid disease; hypertntion; cancer; diabetes melitus.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research institute for endocrine sciences , Shaheed Beheshti University of Medic
Street address
NO 24, Parvaneh st., Yaman st., Velenjak
City
Tehran
Postal code
19395-4763
Approval date
2013-02-26, 1391/12/08
Ethics committee reference number
17ECRIES91/12/08
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrom
ICD-10 code
E28.2
ICD-10 code description
E28.2
Primary outcomes
1
Description
HOMA2IR
Timepoint
3 MONTH
Method of measurement
Laboratory
2
Description
AMH
Timepoint
3Months
Method of measurement
LAB
3
Description
PSA
Timepoint
3 MONTH
Method of measurement
LAB
Secondary outcomes
1
Description
Hirsutism Score
Timepoint
3 months
Method of measurement
clinical
2
Description
Menstural irregularity
Timepoint
3months
Method of measurement
Questionair
Intervention groups
1
Description
Intervention 1- Phlebotomy
Patients undergo venesection of 450 ml of whole blood and are advised not to use any hormonal or iron- containing medications.
Category
Treatment - Other
2
Description
Intervention 2- Cyproterone Compound:
For these patients, three cycles of pills are prescribed. Each cycle includes 21 days of use and 7 days without pills. They should not use any other medications (e.g. hormone(s) or Iron-containing drugs).
After three months, women in both study groups will return for completion of the questionnaire and blood sampling. After six weeks of washout period, two groups are interchanged (i.e., Cyproterone Compound to phlebotomy and vice versa). The hormonal profiles and clinical manifestations of participants in these two groups are compared.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute for Endocrine Sciences, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hayedeh Abtahi
Street address
NO 24, Parvaneh st. Yaman st, Velenjak
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Dr. F. Azizi
Street address
No.24,Parvaneh st., Yaman st., Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine 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
Research Institute for Endocrine Sciences
Full name of responsible person
Dr. Navid Saadat
Position
Endocrinologist
Other areas of specialty/work
Street address
NO 24, Parvaneh st , Yaman st.,Velenjak
City
Tehran
Postal code
19395-4763
Phone
+98 21 2243 2500
Fax
Email
saadat@endocrine.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Dr. Fahimeh Ramezani Tehrani
Position
Gynecologist
Other areas of specialty/work
Street address
NO 24, Parvaneh st. Yaman st., Velenjak
City
Tehran
Postal code
19395-4763
Phone
+98 21 2243 2500
Fax
Email
ramezani@endocrine.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Dr. Hayedeh Abtahi
Position
Endocrinologist
Other areas of specialty/work
Street address
NO 24 , Parvaneh st. Yaman st. ,Velenjak
City
Tehran
Postal code
19395-4763
Phone
+98 21 2243 2500
Fax
Email
habtahii@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)