Symptoms and General Pathology

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Contraceptives, Oral

Chlormadinone Acetate

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Mineralocorticoids

Hormones

Hormone Antagonists

Diuretics

Diuretics, Potassium Sparing

Contraceptive Agents, Female

This group will receive an oral contraceptive containing 0,03mg ethynylestradiol and 2mg chlormadinone acetate

The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.

The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg metformin.

oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months

oral contraceptive

Oral contraceptive plus spironolactone

Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin

Oral contraceptive plus metformin

Rui A Ferriani, MD, PhD

Marcos Felipe S de Sa, MD, PhD

Carolina S Vieira, MD, PhD

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.

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

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

University of Sao Paulo

Rui Alberto Ferriani

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women	NCT00842140	Polycystic Ovar...	oral contracept... Oral contracept... Oral contracept...	18 Years - 35 Years	University of Sao Paulo
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women	NCT00842140	Polycystic Ovar...	oral contracept... Oral contracept... Oral contracept...	18 Years - 35 Years	University of Sao Paulo
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women	NCT00842140	Polycystic Ovar...	oral contracept... Oral contracept... Oral contracept...	18 Years - 35 Years	University of Sao Paulo

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