Clinical trial NCT00842140: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
Oral Contraceptives, Hormonal
Cardiovascular Disease
Endothelium
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on hemostatic variables.
timeFrame: 12 months
measure: to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on metabolic variables.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rui A Ferriani, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Marcos Felipe S de Sa, MD, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Carolina S Vieira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: