跳至主要内容
临床试验/NCT01603745
NCT01603745Unknown1 期

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

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
10
试验地点
1
主要终点
cardiovascular risk

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with PCOS aged 18-35 years

排除标准

  • chronic or acute inflammatory disease
  • 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)

研究组 & 干预措施

NOMAC-valerate estradiol

Active Comparator

E/P therapy

干预措施: Zoely (Drug)

Drospirenone/ethinylestradiol

Active Comparator

E/P therapy

干预措施: Yasmin (Drug)

结局指标

主要结局

cardiovascular risk

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosanna Apa

Professor

Catholic University of the Sacred Heart

研究点 (1)

Loading locations...

相似试验