Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on echografic cardiovascular risk markers.
12 months
Yes
Rui A Ferriani, MD, PhD
Study Director
University of Sao Paulo
Brazil: Ministry of Health
HCRP15811/2005
NCT00842140
February 2006
January 2009
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