Clinical trial NCT00593294: Oral Contraceptive and Cardiovascular Risk in PCOS
Official title: Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
oral contraceptives
physical exercise
CVR
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US
timeFrame: Basal and after 3 and 6 months
Secondary outcomes:
measure: Secondary Outcomes: Clinical, hormonal, and metabolic assessments
timeFrame: Basal and after 3 and 6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II"
Study officials:
affiliation: Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
name: Francesco Orio, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
name: Gaetano Lombardi, MD
role: STUDY_DIRECTOR
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy
name: Stefano Palomba, MD
role: STUDY_CHAIR
References:
citation: 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.