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Oral Contraceptive and Cardiovascular Risk in PCOS

NCT00593294 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2008-01-15

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

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

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Francesco Orio, MD,PhD · Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy

  • Gaetano Lombardi, MD · Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy

  • Stefano Palomba, MD · Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-09-30
Completion
2007-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593294 on ClinicalTrials.gov