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Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: oral contraceptive (Drug); Oral contraceptive plus spironolactone (Drug); Oral contraceptive plus metformin (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Rui A Ferriani, MD, PhD, Study Director, Affiliation: University of Sao Paulo
Marcos Felipe S de Sa, MD, PhD, Study Chair, Affiliation: University of Sao Paulo
Carolina S Vieira, MD, PhD, Principal Investigator, Affiliation: University of Sao Paulo

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.

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome:

to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on seric cardiovascular risk markers.

to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on hemostatic variables.

to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on metabolic variables.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

University of Sao Paulo, Ribeirao Preto, Sao Paulo 14049-900, Brazil
Additional Information

Starting date: February 2006
Last updated: July 21, 2010

Page last updated: August 23, 2015

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