NCT01603745

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

PCOS is the most common female endocrinopathy in reproductive age. This syndrome is a heterogeneous condition characterized by several symptoms and clinical signs related to reproductive, cardiometabolic and psychological disorders.We recently demonstrated that young PCOS women show an expansion of an unusual T-cell population with proinflammatory functions, identified by CD4+CD28null T lymphocytes . Of note, this T subpopulation has been found to be expanded in patients with unstable angina, type 2 diabetes (DM2), in absence of clinical evidence of CVD 12, and has been recently associated to recurrent coronary instability .Based on the above mentioned evidences, the aim of the present study is to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patientsTo evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) and NOMAC-valerate estardiol on some cardiovascular risk factors in PCOS patients.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Zoely	1 pill every day
DRUG	Yasmin	1 pill every day

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-05-01
• Completion: 2012-10-01
• First posted: 2012-05-22
• Last updated: 2012-05-22

Locations

1 site across 1 country: Italy