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Brief Title: Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
Official Title: Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women
Study ID: NCT00842140
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 alone or associated with Spironolactone.
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 pharmacological therapy for decades. However, in non-hyperandrogenic women, OC use is associated with higher risk of cardiovascular disease, raising concern about a possible worsening of the unfavorable metabolic and cardiovascular profile of PCOS patients. There is lack of evidence about the impact of PCOS pharmacological therapies on cardiovascular risk markers and the long-term safety of these drugs in PCOS has not been established. The aim of this study is to compare the effect of an OC alone or associated with an anti-androgenic drug (spironolactone) on echografic cardiovascular risk markers, metabolic and hemostatic variables.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Sao Paulo, Ribeirao Preto, Sao Paulo, Brazil
Name: Rui A Ferriani, MD, PhD
Affiliation: University of Sao Paulo
Role: STUDY_DIRECTOR
Name: Marcos Felipe S de Sa, MD, PhD
Affiliation: University of Sao Paulo
Role: STUDY_CHAIR
Name: Carolina S Vieira, MD, PhD
Affiliation: University of Sao Paulo
Role: PRINCIPAL_INVESTIGATOR