PCOS, Therapy and Markers of Cardiovascular Risk

Sponsor

Medical University of Gdansk (Other)

Overall Status

Unknown status

CT.gov ID

NCT01798875

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Primary Outcome Measures

serum C-reactive protein (CRP) levels [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

PCOS

Exclusion Criteria:

diabetes
pregnancy
contraindications to oral contraceptives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical and Experimental Endocrinology, Medical University of Gdansk	Gdansk		Poland

Sponsors and Collaborators

Medical University of Gdansk

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dominik Rachon, M.D. PhD, Medical University of Gdansk

ClinicalTrials.gov Identifier:

NCT01798875

Other Study ID Numbers:

POLovaRIS

First Posted:

Feb 26, 2013

Last Update Posted:

Mar 1, 2013

Last Verified:

Feb 1, 2013

Keywords provided by Dominik Rachon, M.D. PhD, Medical University of Gdansk

Additional relevant MeSH terms:

Metformin

Contraceptive Agents

Contraceptives, Oral

Study Results

No Results Posted as of Mar 1, 2013