Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women
One hundred and fifty PCOS women will be enrolled. The diagnosis of PCOS was made based
according to the Rotterdam criteria (1). Specifically, patients with anovulation and
clinical and/or biochemical hyperandrogenism were enrolled.
Patients will be randomly allocated in three groups (OC, physical exercise and placebo
group) using a computer-software. Fifty PCOS patients will be treated with OC (Drospirenone
3 mg, Ethynylestradiol 30 microgram = Yasmin, Schering, Milan,Italy) other fifty PCOS will
be undergone physical exercise, whereas other fifty will be treated with placebo tablets
(one tablet once daily; placebo group). The duration of the treatment will be 6 months.
Patients treated with OC will be instructed to follow their usual diet and physical
activity, whereas patients undergone to physical exercise will be instructed to follow a
detailed regular physical training program and for the diet they will be advised for the
quality of food to eat. All subjects will be nonsmokers and none will drink alcoholic
beverages.
Each subject will undergo follow-up visits under (at three and 6 months from treatment
starting) and after treatment (at three and 6 months from treatment withdrawal). At each
follow-up visit, in all subjects the same operator will perform clinical, hormonal,
metabolic and cardiovascular assessments by carotid and brachial artery US
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US
Basal and after 3 and 6 months
No
Francesco Orio, MD,PhD
Principal Investigator
Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
Italy: National Institute of Health
2007-12-2871
NCT00593294
January 2006
December 2007
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