PCOS, Therapy and Markers of Cardiovascular Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medical University of Gdansk
Sponsor:
Information provided by (Responsible Party):
Dominik Rachon, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01798875
First received: February 22, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
PCOS
Drug: oral metformin
Drug: oral contraceptive
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • serum C-reactive protein (CRP) levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PCOS

Exclusion Criteria:

  • diabetes
  • pregnancy
  • contraindications to oral contraceptives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798875

Locations
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

No publications provided

Responsible Party: Dominik Rachon, M.D. PhD, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01798875     History of Changes
Other Study ID Numbers: POLovaRIS
Study First Received: February 22, 2013
Last Updated: February 28, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Gdansk:
pcos
metformin
oral contraception
cyproterone acetate

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Contraceptive Agents
Cyproterone Acetate
Contraceptives, Oral
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on September 18, 2014