Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000663853
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
21/06/2012
Date last updated
27/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Metformin potentiate the effect of Rosuvastatin therapy on biochemical markers in Patients with Polycystic Ovary Syndrome?
Scientific title
Does Metformin potentiate the effect of Rosuvastatin therapy on biochemical markers in Patients with Polycystic Ovary Syndrome? A prospective randomized, double-blinded, placebo-controlled study
Secondary ID [1] 280626 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic ovary syndrome (PCOS) 286637 0
Condition category
Condition code
Reproductive Health and Childbirth 286921 286921 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The total number of groups is 2.
group 1 and group 2 take resuvastatin 10 mg once daily only for 3 months.
starting with the fourth month and for 3 months (till the 6th month included), group 1 takes metformin (850 mg twice a day) along with resuvastatin; while group 2 takes placebo pills (microcellullose capsules) in addition to resuvavstatin.
All medications are oral tablets
Intervention code [1] 285024 0
Treatment: Drugs
Comparator / control treatment
comparator/control group: resuvastatin (10 mg once daily for 6 months - oral tablets) with placebo from the 4th till the 6th month.

intervention group: resuvastatin and metformin from the 4th till the 6th month.
Control group
Placebo

Outcomes
Primary outcome [1] 287276 0
change in inflammatory markers in PCOS patients on Resuvastatin if Metformin is added. this is tested by serum assay every 3 months
Timepoint [1] 287276 0
baseline (0 months), 3 months, and 6 months
Secondary outcome [1] 297807 0
menstrual irregularities are assessed every month where the patients keep daily menstrual diary to report it every month.
Timepoint [1] 297807 0
0 month ,3 months ,6 months

Eligibility
Key inclusion criteria
adult females aged 18-55, diagnosed as having PCOS, not planning to conceive
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with cushing's syndrome, hyperprolactinemia, diabetes mellitus, thyroid disease, adrenal hyperplesia, androgen secretingtumors or other endocrinopathies, cancer, kidney or liver disease, and smokers. Patients who have also been treated with hormone medications or any other medication that could interfere with ovarian function, insulin sensitivity and lipid profile within the 3 months prior to their entry into the study are also be excluded. Moreover, since the effect of metformin may be less in subjects with a mean BMI of > 34 kg/m2 and thus pose as a limitation to the study results, patients with a BMI of >34 kg/m2 will be excluded from participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are informed via flyers, by the principal investigator Dr. Ghina Ghazzeeri who is a gynecologist or by the other gynecologists on the floor. if the gynecologists diagnose the patient with PCOS with other inclusion characteristics, he/she will inform the principal investigator about the eligibility of this patient. They will be asked to fill in the questionniare (part 1: socio-demographics, part 2: PCOS-related questions). If eligible, the patient will be asked to refrain from using oral contraceptive pills. patients will then be asked to undergo the proper labs examination.
assigning the patient to either metformin or placebo after 3 months is done by the research assistant; so the person who determined if a subject was eligible for inclusion in the trial won't be aware about the patient's allocation. the allocation concealment will be performed by using numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
this is done by simple randomization (coin-tossing)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 4348 0
Lebanon
State/province [1] 4348 0

Funding & Sponsors
Funding source category [1] 285386 0
University
Name [1] 285386 0
American University of Beirut
Country [1] 285386 0
Lebanon
Primary sponsor type
University
Name
American University of Beirut
Address
American University of Beirut Medical Center
P.O.Box: 11-0236
Riad El Solh, Beirut 1107 2020
Beirut – Lebanon

Location: Cairo Street, Hamra, Beirut, Lebanon
Country
Lebanon
Secondary sponsor category [1] 284278 0
Hospital
Name [1] 284278 0
American University of Beirut Medical Center
Address [1] 284278 0
American University of Beirut Medical Center
P.O.Box: 11-0236
Riad El Solh, Beirut 1107 2020
Beirut ? Lebanon

Location: Cairo Street, Hamra, Beirut, Lebanon
Country [1] 284278 0
Lebanon
Other collaborator category [1] 276847 0
Individual
Name [1] 276847 0
Johny Awwad
Address [1] 276847 0
American University of Beirut Medical Center-7th floor
P.O.Box: 11-0236
Riad El Solh, Beirut 1107 2020
Beirut-Lebanon

Location: Cairo Street, Hamra, Beirut, Lebanon
Country [1] 276847 0
Lebanon
Other collaborator category [2] 276859 0
Individual
Name [2] 276859 0
Sally A. Harajly
Address [2] 276859 0
American University of Beirut Medical Center-8th floor
P.O.Box: 11-0236
Riad El Solh, Beirut 1107 2020
Beirut-Lebanon

Location: Cairo Street, Hamra, Beirut, Lebanon
Country [2] 276859 0
Lebanon

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287404 0
Institutional Review Board
Ethics committee address [1] 287404 0
American University of Beirut Medical Center-facing family medicine building

P.O.Box: 11-0236
Riad El Solh, Beirut 1107 2020
Beirut-Lebanon

Location: Cairo Street, Hamra, Beirut, Lebanon
Ethics committee country [1] 287404 0
Lebanon
Date submitted for ethics approval [1] 287404 0
25/04/2011
Approval date [1] 287404 0
27/06/2011
Ethics approval number [1] 287404 0

Summary
Brief summary
The main objective of this study is to assess whether metformin will potentiate the effect of rosuvastatin therapy on biochemical markers in patients with polycystic ovary syndrome attending the obstetrics and gynecology clinic of the American University of Beirut-Medical Center (AUB-MC) in Beirut, Lebanon.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34274 0
Address 34274 0
Country 34274 0
Phone 34274 0
Fax 34274 0
Email 34274 0
Contact person for public queries
Name 17521 0
Ghina Ghazeeri
Address 17521 0
American University of Beirut Medical Center
P.O.Box: 11-0236
Riad El Solh, Beirut 1107 2020
Beirut – Lebanon

Location: Cairo Street, Hamra, Beirut, Lebanon
Country 17521 0
Lebanon
Phone 17521 0
+9611350000
Fax 17521 0
+961-1-345325
Email 17521 0
gg02@aub.edu.lb
Contact person for scientific queries
Name 8449 0
ghina ghazeeri
Address 8449 0
American University of Beirut Medical Center-8th floor-OBS/GYN department
P.O.Box: 11-0236
Riad El Solh, Beirut 1107 2020
Beirut – Lebanon

Location: Cairo Street, Hamra, Beirut, Lebanon
Country 8449 0
Lebanon
Phone 8449 0
+9611350000
Fax 8449 0
+961-1-345325
Email 8449 0
gg02@aub.edu.lb

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4360Study results articleYes Ghazeeri, G., Abbas, H. A., Skaff, B., Harajly, S.... [More Details] 362596-(Uploaded-17-07-2020-20-28-33)-Journal results publication.pdf

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