Oral Contraceptive and Cardiovascular Risk in PCOS
|ClinicalTrials.gov Identifier: NCT00593294|
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : January 15, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Behavioral: Physical exercise Drug: OC - Drospirenone plus Ethynylestradiol Dietary Supplement: Vitamin, polyvitamins tablets||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women|
|Study Start Date :||January 2006|
|Primary Completion Date :||September 2007|
|Study Completion Date :||December 2007|
Behavioral: Physical exercise
45 minutes each day for three times/week for 6 months
|Active Comparator: B, 2, II||
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)
|Placebo Comparator: C,3,III||
Dietary Supplement: Vitamin, polyvitamins tablets
Tablet of vitamin 1cp for 21 days each month for 6 months
- Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US [ Time Frame: Basal and after 3 and 6 months ]
- Secondary Outcomes: Clinical, hormonal, and metabolic assessments [ Time Frame: Basal and after 3 and 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593294
|Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II"|
|Naples, Italy, 80131|
|Principal Investigator:||Francesco Orio, MD,PhD||Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy|
|Study Director:||Gaetano Lombardi, MD||Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy|
|Study Chair:||Stefano Palomba, MD||Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy|