Text Size

Oral Contraceptive and Cardiovascular Risk in PCOS

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00593294
First received: January 4, 2008
Last updated: January 14, 2008
Last verified: December 2007
History of Changes

January 4, 2008
January 14, 2008
January 2006
September 2007   (final data collection date for primary outcome measure)
Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US [ Time Frame: Basal and after 3 and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00593294 on ClinicalTrials.gov Archive Site
Secondary Outcomes: Clinical, hormonal, and metabolic assessments [ Time Frame: Basal and after 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Oral Contraceptive and Cardiovascular Risk in PCOS
Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • 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
  • Experimental: A,1,I
    Intervention: Behavioral: Physical exercise
  • Active Comparator: B, 2, II
    Intervention: Drug: OC - Drospirenone plus Ethynylestradiol
  • Placebo Comparator: C,3,III
    Intervention: Dietary Supplement: Vitamin, polyvitamins tablets
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2007
September 2007   (final data collection date for primary outcome measure)

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)
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00593294
2007-12-2871, CE209/07
No
Francesco Orio, Dpt of Mol and Clin Endocrinology and Oncology Federico II University of Naples
Federico II University
Not Provided
Principal Investigator: Francesco Orio, MD,PhD Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
Study Director: Gaetano Lombardi, MD Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy
Study Chair: Stefano Palomba, MD Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy
Federico II University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP