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PCOS, Therapy and Markers of Cardiovascular Risk

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ClinicalTrials.gov Identifier: NCT01798875
Recruitment Status : Unknown
Verified February 2013 by Dominik Rachon, Medical University of Gdansk.
Recruitment status was:  Recruiting
First Posted : February 26, 2013
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
Dominik Rachon, Medical University of Gdansk

Study Description
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Brief Summary:
In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS) is also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead to the development of diabetes, hypertension, atherosclerosis and coronary heart disease. Serum markers of inflammation are being increasingly recognized as predictors of atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes mellitus. Therefore, the aim of the present study is to evaluate the effects of commonly used non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives, metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular risk markers in women with PCOS. The study hypothesis is that some of the commonly used therapies of women with PCOS may have more favorable effects on classical and surrogate markers of cardiovascular risk then others or some of them may even confer a higher risk of cardiovascular events

Condition or disease Intervention/treatment Phase
PCOS Drug: oral metformin Drug: oral contraceptive Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)
Study Start Date : April 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Metformin
oral metformin at a dose of 850mg twice daily
 Drug: oral metformin
Active Comparator: Oral contraceptive
oral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen)
 Drug: oral contraceptive


Outcome Measures
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Primary Outcome Measures :
  1. serum C-reactive protein (CRP) levels [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PCOS

Exclusion Criteria:

  • diabetes
  • pregnancy
  • contraindications to oral contraceptives
Contacts and Locations
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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): NCT01798875


Locations
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Poland
Department of Clinical and Experimental Endocrinology, Medical University of Gdansk Recruiting
Gdansk, Poland
Contact: Dominik Rachon, MD, PhD    +48583491947    drachon@gumed.edu.pl   
Principal Investigator: Monika Kuligowska-Jakubowska, MD         
Principal Investigator: Jolanta Dardzinska, MD, PhD         
Sub-Investigator: Agnieszka Kowalewska-Wlas, MD, PhD         
Principal Investigator: Aleksandra Rutkowska, MSc, PhD         
Principal Investigator: Justyna Breska-Kruszewska, MSc         
Sponsors and Collaborators
Medical University of Gdansk
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dominik Rachon, M.D. PhD, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01798875    
Other Study ID Numbers: POLovaRIS
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013
Keywords provided by Dominik Rachon, Medical University of Gdansk:
pcos
metformin
oral contraception
cyproterone acetate
Additional relevant MeSH terms:
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Metformin
Contraceptive Agents
Contraceptives, Oral
Hypoglycemic Agents
 Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female