PCOS, Therapy and Markers of Cardiovascular Risk

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. 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
Information provided by (Responsible Party):
Dominik Rachon, Medical University of Gdansk

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 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

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • PCOS

Exclusion Criteria:

  • diabetes
  • pregnancy
  • contraindications to oral contraceptives

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 identifier (NCT number): NCT01798875

Department of Clinical and Experimental Endocrinology, Medical University of Gdansk Recruiting
Gdansk, Poland
Contact: Dominik Rachon, MD, PhD    +48583491947   
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dominik Rachon, M.D. PhD, Medical University of Gdansk Identifier: NCT01798875     History of Changes
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:
oral contraception
cyproterone acetate

Additional relevant MeSH terms:
Contraceptive Agents
Cyproterone Acetate
Contraceptives, Oral
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male