NCT00593294

Oral Contraceptive and Cardiovascular Risk in PCOS

Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Physical exercise	45 minutes each day for three times/week for 6 months
DRUG	OC - Drospirenone plus Ethynylestradiol	1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy)
DIETARY_SUPPLEMENT	Vitamin, polyvitamins tablets	Tablet of vitamin 1cp for 21 days each month for 6 months

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-09-01
• Completion: 2007-12-01
• First posted: 2008-01-15
• Last updated: 2008-01-15

Locations

1 site across 1 country: Italy