Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia, hypertension, oxidative stress and inflammation are associated with PCOS. The investigators want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in PCOS.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Estradiol; Ethinyl Estradiol

Criteria

Inclusion Criteria:

• patients with PCOS aged 18-35 years

Exclusion Criteria:

• chronic or acute inflammatory disease

• cancer

• autoimmune disease

• treatment with clomiphene citrate

• antiandrogens

• drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes)