Oral Contraceptive and Cardiovascular Risk in PCOS

NCT ID: NCT00593294

Last Updated: 2008-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-12-31

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

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A,1,I

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: BEHAVIORAL

45 minutes each day for three times/week for 6 months

B, 2, II

Group Type: ACTIVE_COMPARATOR

OC - Drospirenone plus Ethynylestradiol

Intervention Type: DRUG

1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy)

C,3,III

Group Type: PLACEBO_COMPARATOR

Vitamin, polyvitamins tablets

Intervention Type: DIETARY_SUPPLEMENT

Tablet of vitamin 1cp for 21 days each month for 6 months

Interventions

Physical exercise

45 minutes each day for three times/week for 6 months

Intervention Type: BEHAVIORAL

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)

Intervention Type: DRUG

Vitamin, polyvitamins tablets

Tablet of vitamin 1cp for 21 days each month for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Dpt of Mol and Clin Endocrinology and Oncology Federico II University of Naples

Principal Investigators

Francesco Orio, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Gaetano Lombardi, MD

Role: STUDY_DIRECTOR

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

Stefano Palomba, MD

Role: STUDY_CHAIR

Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy

Locations

Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II"

Naples, Naples, Italy

Countries

Italy

References

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. doi: 10.1016/j.fertnstert.2003.10.004.

Reference Type: BACKGROUND

PMID: 14711538 (View on PubMed)

Other Identifiers

CE209/07

Identifier Type: -

Identifier Source: secondary_id

2007-12-2871

Identifier Type: -

Identifier Source: org_study_id