Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
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.
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.
Inclusion Criteria:

 -  age between 18 and 35 years

 -  diagnosis of PCOS by Rotterdam Consensus

 Exclusion Criteria:

 -  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