Status:
COMPLETED
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
Lead Sponsor:
University of Sao Paulo
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
The purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate a...
Detailed Description
Polycystic ovary syndrome (PCOS) is associated with comorbidities that may contribute to increased risk of cardiovascular disease (CVD). Oral contraceptives (OC) have been the mainstay of PCOS pharmac...
Eligibility Criteria
Inclusion
- age between 18 and 35 years
- diagnosis of PCOS by Rotterdam Consensus
Exclusion
- smoking, alcoholism, drug addiction;
- current pregnancy;
- current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives;
- current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device);
- antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins;
- presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia);
- personal history of arterial or venous thrombosis; chronic or acute inflammatory processes;
- puerperium of 12 weeks or less
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00842140
Start Date
February 1 2006
End Date
January 1 2009
Last Update
July 22 2010
Active Locations (1)
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1
University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900