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

Phase 4
18 Years
40 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

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

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

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

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US

Outcome Time Frame:

Basal and after 3 and 6 months

Safety Issue:


Principal Investigator

Francesco Orio, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy


Italy: National Institute of Health

Study ID:




Start Date:

January 2006

Completion Date:

December 2007

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • oral contraceptives
  • physical exercise
  • CVR
  • Polycystic Ovary Syndrome