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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Chlormadinone Acetate; Contraceptive Agents; Contraceptives, Oral; Ethinyl Estradiol; Metformin; Spironolactone

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