Spots Global Cancer Trial Database for Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women

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Trial Identification

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

Conditions

Polycystic Ovary Syndrome

Interventions

oral contraceptive

Oral contraceptive plus spironolactone

Oral contraceptive plus metformin

Study Description

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.