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Oral Contraceptive and Cardiovascular Risk in PCOS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593294
First Posted: January 15, 2008
Last Update Posted: January 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federico II University
  Purpose

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.


Condition Intervention Phase
Polycystic Ovary Syndrome Behavioral: Physical exercise Drug: OC - Drospirenone plus Ethynylestradiol Dietary Supplement: Vitamin, polyvitamins tablets Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Secondary Outcomes: Clinical, hormonal, and metabolic assessments [ Time Frame: Basal and after 3 and 6 months ]

Enrollment: 150
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,1,I Behavioral: Physical exercise
45 minutes each day for three times/week for 6 months
Active Comparator: B, 2, II 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)
Placebo Comparator: C,3,III Dietary Supplement: Vitamin, polyvitamins tablets
Tablet of vitamin 1cp for 21 days each month for 6 months

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

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593294


Locations
Italy
Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II"
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
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
  More Information

Publications:
Responsible Party: Francesco Orio, Dpt of Mol and Clin Endocrinology and Oncology Federico II University of Naples
ClinicalTrials.gov Identifier: NCT00593294     History of Changes
Other Study ID Numbers: 2007-12-2871
CE209/07
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: January 15, 2008
Last Verified: December 2007

Keywords provided by Federico II University:
PCOS
oral contraceptives
physical exercise
CVR

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamins
Contraceptive Agents
Contraceptives, Oral
Drospirenone
Ethinyl Estradiol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Estrogens
Hormones