None listed
Conditions
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.
Interventions
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
Sponsors
American University of Beirut
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
adult females aged 18-55, diagnosed as having PCOS, not planning to conceive
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.
Outcome results
None listed