Oral Contraceptive and Cardiovascular Risk in PCOS
Information source: Federico II University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Physical exercise (Behavioral); OC - Drospirenone plus Ethynylestradiol (Drug); Vitamin, polyvitamins tablets (Dietary Supplement)
Phase: Phase 4
Status: Completed
Sponsored by: Federico II University Official(s) and/or principal investigator(s):
Francesco Orio, MD,PhD, Principal Investigator, Affiliation: Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
Gaetano Lombardi, MD, Study Director, Affiliation: Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
Stefano Palomba, MD, Study Chair, Affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy
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.
Clinical Details
Official title: Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US
Secondary outcome: Secondary Outcomes: Clinical, hormonal, and metabolic assessments
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.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Polycystic ovary syndrome
Exclusion Criteria:
- Age <18 or >40 years
- BMI higher than 30 and lower than 18
- Pregnancy
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital
adrenal hyperplasia, use of OC, glucocorticoids, antiandrogens, ovulation induction
agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous
6 months
- Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and
cardiovascular disorder or other concurrent medical illness (i. e. diabetes, renal
disease, or malabsorptive disorders, cephalea)
Locations and Contacts
Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II", Naples 80131, Italy
Additional Information
Related publications: Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25.
Starting date: January 2006
Ending date: December 2007
Last updated: January 14, 2008
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