This randomized clinical trial is conducted on 100 women (18-28 years old) with a diagnosis of polycystic ovary syndrome (PCOS ) with Hirsutism who are referred to our researcher center for treatment of disease and taking contraceptive necessities. PCOS is defined as diagnostic criteria of 2003 census Rotterdam. Hirsutism is defined as the presence of excessive hair in body and Ferriman –Gallway score >=8. The ultrasound examination of the uterus and ovaries is performed with using a multi frequency trans-abdominal transducer (Esaote My Lab 40). Endometrial thickness, ovarian volume, number Struma are recorded. Blood samples for serum FSH, LH, free testosterone, androstendion, 17-hydroxy progesterone (17 -OHP), and sex hormone binding globulin are taken at baseline and at the end of the treatment at the early follicular phase between 4th to 5th days of menstrual cycle at 8 Am. FSH/ LH concentration ratio and free androgen index (FAI) are calculated. The women are randomly allocated to oral treatment with Yasmin (Drospirenone 3 mg+ 30 EE µg) through days 1-21 of menstrual cycle (group 1; n= 50) or Cyproteron compound (2 mg Cyproteron acetate + 35 µg EE) through days 1-21 of menstrual cycle (group 2; n= 50). The women are studied at the baseline condition and after 6 month of therapy. Women will participate in the study after an informed written consent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104251760N13
Registration date:2012-03-04, 1390/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-04, 1390/12/14
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
2012-02-20, 1390/12/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combined oral contraceptive Yasmin and Cyproteron compound on Hirsutism and androgens in women with a polycystic ovary syndrome
Public title
Comparison of combined oral contraceptive Yasmin and Cyproteron compound on Hirsutism and androgens in women with a polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-28 years old nonsmoker women with polycystic ovary syndrome and Hirsutism who are raftered to our research center for treatment of Hirsutism and taking contraceptive necessities. Exclusion criteria: Hyper-prolactinemia; Hypothyroidism; diabetes; doing regular intense exercise; taking diet or herbal treatment, Non-steroidal anti- inflammatory drugs, diuretics, or hormone therapy during last 3 months.
Age
From 18 years old to 28 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Approval date
2012-02-13, 1390/11/24
Ethics committee reference number
5720
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
2
Description of health condition studied
Hirsutism
ICD-10 code
L68
ICD-10 code description
Hypertrichosis
Primary outcomes
1
Description
Back spontaneous menstrual
Timepoint
6 months after cessation of treatment
Method of measurement
Clinical examination
Secondary outcomes
1
Description
side effects of drugs (such as complaints of headaches and spotting)
Timepoint
4 months
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention Groups: Yasmin pills (containing Drospirenone 3 mg+30 g Ethinyl Estradiol), from 1-21 day cycle for 4 months.
Category
Treatment - Drugs
2
Description
Control group: Cyproterone Compound Tablets (2 mg Cyproteron acetate + 35 µg Ethinyl Estradiol) from day 21 to 1 cycle for 4 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh-Zahra Fertility & infertility Medical Center
Full name of responsible person
Dr. Molood Aghajani Delavar
Street address
After Mohammad Hassan Khan Bridge, Old Road, Amol, Babol, Fatemeh-Zahra Medical Center-Fatemeh-zahra Infertility & Reproductive Health ResearchCenter
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
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, 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 Infertility & reproductive Health Research Center
Full name of responsible person
Dr. Molod Aghajani-delavar
Position
PhD in Women's Health
Other areas of specialty/work
Street address
Fatemehzahra Infertility & reproductive Health Research Center, After Mohammad Hassan Khan Bridge, old Road Amol
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
moloodaghajani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh-Zahra, Infertility & Reproductive Health Research Center
Full name of responsible person
Dr. Seddigheh Esmaeilzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Infertility & Reproductive Health Research Center, After Mohammad Hassan Khan Bridge, old Road Amol
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
sesmael@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Infertility & Reproductive Health Research Center, After Mohammad Hassan Khan Bridge, Old Road Amol
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)