Polycystic Ovary Syndrome Clinical Trial
Official title:
Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women
Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of
patients with polycystic ovary syndrome (PCOS).
To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data
are available on the CVR in PCOS patients treated with OC or physical exercise.
The purpose of this study is to compare the effects of OC to physical exercise on the CVR of
PCOS women and show the hormonal and metabolic effects of these two different treatment.
We hypothesize that physical exercise has the same beneficial effects of OC therapy on
hormonal and metabolic features of PCOS women with less cardiovascular consequences.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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