Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000886987
Ethics application status
Approved
Date submitted
16/08/2011
Date registered
19/08/2011
Date last updated
19/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of metformin plus rosuvastatin on hyperandrogenism in polycystic ovary syndrome patients with hyperlipidemia and impaired glucose tolerance
Scientific title
Effects of metformin plus rosuvastatin on hyperandrogenism in polycystic ovary syndrome patients with hyperlipidemia and impaired glucose tolerance
Secondary ID [1] 262845 0
Nil
Universal Trial Number (UTN)
-
Trial acronym
-
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polycystic ovary syndrome 270567 0
hyperlipidemia and impaired glucose tolerance 270568 0
Condition category
Condition code
Metabolic and Endocrine 270736 270736 0 0
Metabolic disorders
Blood 270750 270750 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group MR : Lifestyle intervention ( 1 hour sessions / 2 times a week moderately physical activity and exercise, indivudial dietary modification monitoring by a dietitian ), plus metformin (2000mg/day, peroral) plus rosuvastatin therapies (10 mg/day rosuvastatin, per oral, n= 18) for 12 weeks.
Intervention code [1] 269201 0
Treatment: Drugs
Intervention code [2] 269212 0
Lifestyle
Comparator / control treatment
Group M: Lifestyle intervention ( 1 hour sessions / 2 times a week , moderately physical activity and exercise, indivudial dietary modification monitoring by a dietitian) plus metformin therapy (2000mg/day, per oral, n= 20) for 12 weeks
Control group
Active

Outcomes
Primary outcome [1] 269435 0
Total and free testosterone, insulin, glucose and hs-CRP levels. Blood samples were obtained before and after treatment. They assesed with biochemical tests.
Timepoint [1] 269435 0
before treatment and after 12 weeks of treatment
Secondary outcome [1] 287641 0
Nil
Timepoint [1] 287641 0
Nil

Eligibility
Key inclusion criteria
PCOS was defined according to Rotterdam European Society for Human Reproduction and Embryology (ESHRE) and the American Society for Reproductive Medicine(ASRM) consensus workshop. All patients had at least two of the following three criteria: chronic anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovaries on ultrasound (USG).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients who had liver and kidney diseases and using drugs affecting insulin sensitivity and lipid profile and oral contraceptives within the last six months were excluded from the study. Patients with Cushing's syndrome, hyperprolactinemia, diabetes mellitus, thyroid disease, congenital adrenal hyperplasia and androgen-secreting tumors, insufficient LH syndrome and other endocrinopathies were also excluded from 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 were assigned to receive lifestyle-intervention (diet and exercise) and metformin (2000mg/day, n= 20, M group) therapy or lifestyle-intervention, metformin plus rosuvastatin therapies (2000mg/day metformin and 10 mg/day rosuvastatin, n= 18, MR group) for 12 weeks.
For statin administration, newly diagnosed PCOS patients with hyperlipidemia and IGT were selected among PCOS patients at high risk for cardiovascular disease. PCOS patients with a LDL-cholesterol level>130 mg/dL and triglyceride (TG) level>150 mg/dL were considered as hyperlipidemic patients. Among hyperlipidemic patients, 18 patients with a LDL-cholesterol level> 160 mg/dL were scheduled to receive additional rosuvastatin therapy. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation used according to their lipid profile. PCOS patients with a LDL-cholesterol level>130 mg/dL and triglyceride (TG) level>150 mg/dL were considered as hyperlipidemic patients. Among hyperlipidemic patients, 18 patients with a LDL-cholesterol level> 160 mg/dL were scheduled to receive additional rosuvastatin therapy. 20 patients received only metformin therapy.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3790 0
Turkey
State/province [1] 3790 0
Istanbul

Funding & Sponsors
Funding source category [1] 269666 0
University
Name [1] 269666 0
Istanbul University
Country [1] 269666 0
Turkey
Primary sponsor type
Individual
Name
Ozlem Celik
Address
Istanbul University
Cerrahpasa Tip Fakultesi , Ic Hastaliklari Anabilim Dali
Endokrinoloji-Metabolizma ve Diyabet Bilim Dali , 34303
Cerrahpasa , Istanbul ,
Country
Turkey
Secondary sponsor category [1] 266703 0
None
Name [1] 266703 0
Address [1] 266703 0
Country [1] 266703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269620 0
Istanbul University, Cerrahpasa Medical School
Ethics committee address [1] 269620 0
Istanbul University, Cerrahpasa Medical School,
Cerrahpasa Tip Fakultesi , Ic Hastaliklari Anabilim Dali
Endokrinoloji-Metabolizma ve Diyabet Bilim Dali , 34303
Kocamustafapasa, Istanbul ,
Ethics committee country [1] 269620 0
Turkey
Date submitted for ethics approval [1] 269620 0
22/04/2009
Approval date [1] 269620 0
05/05/2009
Ethics approval number [1] 269620 0
4004

Summary
Brief summary
Objective: We aimed to compare the effects of metformin and metformin plus rosuvastatin combination therapies on hyperandrogenism in patients with polycystic ovary syndrome (PCOS).
Design: A prospective, randomized study.
Setting: University hospital.
Patients: Thirty-eight PCOS patients with hyperlipidemia and impaired glucose tolerance (IGT) were included in the study.
Interventions: Patients were assigned to receive lifestyle intervention and metformin (2000mg/day, n= 20, M group) therapy or lifestyle intervention, metformin (2000mg/day) plus rosuvastatin therapies (10 mg/day rosuvastatin, n= 18, MR group) for 12 weeks. Blood samples were obtained before and after treatment.
Main Outcome Measures: Total and free testosterone, insulin, glucose and hs-CRP levels. Results: After 12 weeks of treatment body mass index (BMI), insulin and glucose levels, HOMA-IR had similar decreaments in both groups (p= 0.5, p=0.97, p=0.74, p=0.94), whereas there was a greater decline of the total and free testosterone levels in MR group (p< 0.001, p= 0.004). DHEAS levels did not change in M group however significantly decreased in MR group after treatment (p=0.8, p=0.002). As expected hsCRP, triglyceride, total and LDL- cholesterol levels decreased more in MR group.
Conclusion: Metformin and rosuvastatin combination therapy was proved to have more favorable effect on hyperandrogenism. Therefore statin therapy in PCOS patients with hyperlipidemia and higher cardiovascular risk can render hyperandrogenism treatment more successful.
Trial website
-
Trial related presentations / publications
-
Public notes

Contacts
Principal investigator
Name 33025 0
Address 33025 0
Country 33025 0
Phone 33025 0
Fax 33025 0
Email 33025 0
Contact person for public queries
Name 16272 0
Ozlem Celik
Address 16272 0
Cerrahpasa Tip Fakultesi , Ic Hastaliklari Anabilim Dali
Endokrinoloji-Metabolizma ve Diyabet Bilim Dali , 34303
Cerrahpasa , Istanbul ,
Country 16272 0
Turkey
Phone 16272 0
90 532 7421609
Fax 16272 0
90 212 233 38 06
Email 16272 0
[email protected]
Contact person for scientific queries
Name 7200 0
Ozlem Celik
Address 7200 0
Cerrahpasa Tip Fakultesi , Ic Hastaliklari Anabilim Dali
Endokrinoloji-Metabolizma ve Diyabet Bilim Dali , 34303
Cerrahpasa , Istanbul ,
Country 7200 0
Turkey
Phone 7200 0
90 532 7421609
Fax 7200 0
90 212 233 38 06
Email 7200 0
[email protected]

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