A randomized clinical trial to compare the effectiveness of oral contraceptives containing levonorgestrel, desogestrel, cyproterone acetate, and drospirenone on levels of adipokines, and adiposity indices in women with polycystic ovary syndrome.
To compare the effects of oral contraceptives containing levonorgestrel (LNG), desogestrel (DSG), Cyproterone Acetate (CPA), and drospirenone on serum adipokines including adiponectin, leptin and resistin in patients with polycystic ovarian syndrome (PCOS ).
Design
This study is a randomized single blinded parallel clinical trial. Sample size is estimated as 80 person. This clinical trial is placed in phase 3 of clinical trials.
Settings and conduct
This randomized clinical trial will be done in the Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Present study will be done single-blind in which outcome assessor will be kept blind and won’t be aware of the type of drug that the patients will receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria: presence of diagnostic criteria for polycystic ovary syndrome based on the Androgen Excess and PCOS Society (AES); ages 18 to 45 years. Exclusion criteria: Pregnancy; Use of hormone drugs, anti-androgens and insulin sensitizers for at least three months; Smoking; Obesity; Chronic medical disorders; Serious side effects such as thrombosis.
Intervention groups
Intervention Group 1: Oral contraceptives (OCs) containing Levonorgestrel.
Intervention Group 2: OCs containing Desogestrel.
Intervention Group 3: OCs containing Cyproterone Acetate.
Intervention Group 4: OCs containing Drospirenone.
Main outcome variables
Adiponectin; leptin; resistin.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080929001281N3
Registration date:2020-03-26, 1399/01/07
Registration timing:retrospective
Last update:2020-03-26, 1399/01/07
Update count:0
Registration date
2020-03-26, 1399/01/07
Registrant information
Name
Fahimeh Ramezani Tehrani
Name of organization / entity
Research Institute for Endocrine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
ramezani@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-24, 1398/03/03
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial to compare the effectiveness of oral contraceptives containing levonorgestrel, desogestrel, cyproterone acetate, and drospirenone on levels of adipokines, and adiposity indices in women with polycystic ovary syndrome.
Public title
Effect of oral contraceptives on levels of adipokines, and adiposity indices in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of diagnostic criteria for polycystic ovary syndrome based on Androgen Excess and PCOS Society (AES)
Age range: 18 to 45 years
Exclusion criteria:
Pregnancy
Use of hormonal; anti-androgen or insulin sensitizer drugs for at least 3 months before the study
Detection of severe hypertension; chronic disease; recent surgery or diagnosis of cancer
Smoking
Obesity
Appearing the serious side effects such as thrombosis
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A blocking or stratification random allocation (block size = 4), using a computer-based random number generator will be prepared to assign participants to treatment groups. The randomization sequence will be prepared before the trial, initiated by an independent statistician.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both the clinical examiner and data analyst are blinded to the intervention each patient receives during the trial. For this purpose, before beginning the study, a person outside the research team who knew the interventions, assigned patients to treatment groups. Hence, only this person was aware of the treatment in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences.
Street address
Research Institute for Endocrine Sciences, Shahid Aarabi street, Yaman street, Velenjac
City
تهران
Province
Tehran
Postal code
1985717413
Approval date
2018-08-14, 1397/05/23
Ethics committee reference number
IR.SBMU.ENDOCRINE.REC.1397.055
Health conditions studied
1
Description of health condition studied
Reproductive health.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum levels of adiponectin
Timepoint
baseline, 6th month
Method of measurement
Assessment of this parameter will be done using Human ELISA kites.
2
Description
Serum levels of leptin
Timepoint
baseline, 6th month
Method of measurement
Assessment of this parameter will be done using Human ELISA kites.
3
Description
Serum levels of resistin
Timepoint
baseline, 6th month
Method of measurement
Assessment of this parameter will be done using Human ELISA kites.
Secondary outcomes
1
Description
Blood pressure
Timepoint
Baseline, 6th month
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Intervention group 1: Oral contraceptives containing Ethinyl estradiol (EE) 30 µg + levonorgestrel 0.15 mg (daily for 21 days and then 7 days withdrawal) made by Iran Hormone company, Iran.
Category
Treatment - Drugs
2
Description
Intervention group 2: oral contraceptives containing Ethinyl estradiol (EE) 30 µg + Desogestrel 150 µg (daily for 21 days and then 7 days withdrawal) made by Iran Hormone company, Iran.
Category
Treatment - Drugs
3
Description
Intervention group 3: oral contraceptives containing Ethinyl estradiol (EE) 35 µg + Cyproterone acetate (CPA) 2 mg (daily for 21 days and then 7 days withdrawal) made by Iran Hormone company, Iran.
Category
Treatment - Drugs
4
Description
Intervention group 4: oral contraceptives containing Ethinyl estradiol (EE) 30 µg + Drospirenone (DRSP) 3 mg (daily for 21 days and then 7 days withdrawal) made by Iran Hormone company, Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine out-patients clinic, Research Institute for Endocrine Sciences (RIES), Shahid Beheshti Uni
Full name of responsible person
Fahimeh Ramezani Tehrani
Street address
No.24, Aarabi street, Yaman street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
ramezani@endocrine.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Aarabi street, Yaman street, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Research Institute for Endocrine Sciences, No.24, Aarabi street, Yaman street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
mina_amiri_p@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research Institute for Endocrine Sciences, No.24, Aarabi street, Yaman street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
ramezani@endocrine.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Research Institute for Endocrine Sciences, No.24, Aarabi street, Yaman street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
mina_amiri_p@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
َAfter completion of the study, part of the data, such as information about the main outcomes will be shared.
When the data will become available and for how long
Starting availability of data is 6 months after publishing the results.
To whom data/document is available
The data of this study will be available to all medical science researchers.
Under which criteria data/document could be used
Researchers are only permitted to use the above study information as descriptive analysis or as part of a meta-analysis.
From where data/document is obtainable
Applicants can contact Dr. Mina Amiri, Academic Member of the University of Medical Sciences, through the following address, contact number and email:
Address: No 24, Institute of Endocrinology and Metabolism, Aarabi street, Yemen street, Velenjak.
Phone: 00982122432569
Postcode: 1985717413
Email: mina_amiri_p@yahoo.com
What processes are involved for a request to access data/document
1- Submit a request to access the data file by email
2. Submission of a formal application form for the relevant research project and the need for the above study data by the applicants: This form should only be issued through accredited research bodies.
3- Applicant's visit to Shahid Beheshti Institute of Endocrinology and Metabolism Research Institute to complete consent form to comply with ethical obligations required to use data
4- Investigating the Applicants' Application in the Scientific Committee of the Endocrinology Institute and Deciding to Submit Data as Non-Identifiable Study Participants (Maximum Within One Month)
5- Send study data to researcher's email
6. Monitor how data is used