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

Phase 1

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Zoely; Drug: Yasmin

• Registration Number: NCT01603745
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study First Submitted: 2012-05-19
• Study First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Study First Posted: 2012-05-22
• Last Update Posted: 2012-05-22
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NOMAC-valerate estradiol	Zoely	E/P therapy
Drospirenone/ethinylestradiol	Yasmin	E/P therapy

Primary Outcome Measures

Name	Time	Method
cardiovascular risk	120 minutes	total testosterone (T), SHBG, androstenedione (A), 17-hydroxyprogesterone (17-OHP), dehydroepiandrosterone sulphate (DHEAS), triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol (HDL and LDL cholesterol) and alanine aminotransferase (ALT),CD4+CD28null frequency

Trial Locations

Locations (1)

Catholic university of Sacred Heart; 🇮🇹 Rome, Italy