Spots Global Cancer Trial Database for Oral Contraceptive and Cardiovascular Risk in PCOS
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Trial Identification
Brief Title: Oral Contraceptive and Cardiovascular Risk in PCOS
Official Title: Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women
Study ID: NCT00593294
Conditions
Study Description
Brief 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II", Naples, , Italy
Contact Details
Name: Francesco Orio, MD,PhD
Affiliation: Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Gaetano Lombardi, MD
Affiliation: Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
Role: STUDY_DIRECTOR
Name: Stefano Palomba, MD
Affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy
Role: STUDY_CHAIR
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