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Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women

18 Years
35 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

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.

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

- puerperium of 12 weeks or less

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Rui A Ferriani, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

University of Sao Paulo


Brazil: Ministry of Health

Study ID:




Start Date:

February 2006

Completion Date:

January 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovary syndrome
  • Oral Contraceptives, Hormonal
  • Cardiovascular Disease
  • Endothelium
  • Polycystic Ovary Syndrome