Suspended

Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

oral metformin

+ oral contraceptive

Drug
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Adnexal Diseases

From 18 to 35 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorMedical University of Gdansk
Study ContactDominik Rachon, MD, PhDMore contacts
Last updated: March 1, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01798875
Principal SponsorMedical University of Gdansk
Study ContactDominik Rachon, MD, PhDMore contacts
Last updated: March 1, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCystsEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersNeoplasmsOvarian CystsOvarian DiseasesFemale Urogenital DiseasesPolycystic Ovary Syndrome

Criteria

1 inclusion criteria required to participate
PCOS
3 exclusion criteria prevent from participating
contraindications to oral contraceptives
diabetes
pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
oral metformin at a dose of 850mg twice daily

Group II

Active Comparator
oral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Clinical and Experimental Endocrinology, Medical University of Gdansk

Gdansk, PolandOpen Department of Clinical and Experimental Endocrinology, Medical University of Gdansk in Google Maps
SuspendedOne Study Center