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
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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 |

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)
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Drug: oral contraceptive |
- serum C-reactive protein (CRP) levels [ Time Frame: 6 months ]

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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

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
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 |
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 |
pcos metformin oral contraception cyproterone acetate |
Metformin Contraceptive Agents Contraceptives, Oral Hypoglycemic Agents |
Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female |