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临床试验/EUCTR2005-004163-39-ES
EUCTR2005-004163-39-ES进行中(未招募)不适用

Effects on Endocrine-Metabolic Parameters and Body Composition of the Addition of Low-Dose Pioglitazone to Flutamide-Metformin Therapy in Young Women with Hyperinsulinemic Ovarian Hyperandrogenism and Cardiovascular Risk - Pioglitazone in PCOS

Hospital Sant Joan de Déu0 个研究点目标入组 40 人开始时间: 2005年10月5日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • 1-age 18 years or above
  • 2-menarche at least 3 yr before study start
  • 3-hyperandrogenism, either clinical (hirsutism, acne, menstrual disturbances) or biochemical (increased testosterone, decreased sex hormone-binding globulin, SHBG), or increase free androgen index).
  • 4-hyperinsulinism: increase serum fasting insulin levels (15 uU/mL or more), decreased glucose/insulin ratio (<7), or increased insulin responses (>100 uU/mL) to an oral glucose overload.
  • 5-dyslipidemia: decreased HDL-cholesterol; increased LDL-cholesterol and tryglicerides
  • 6-neutrophilia (>3,7 x mm3); increased CRP (> 2mg/L).
  • 7-normal liver, kidney and adrenal functions
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1-age less than 18
  • 2-pregnancy
  • 3-hyperprolactinemia, Cushing's syndrome, thyroid dysfunction, liver, kidney or adrenal disease, inflammatory bowel disease, family or personal history of diabetes mellitus or glucose intolerance, abnromal echocardiography
  • 4-therapy with anti-androgens, estroprogestagens, antibiotics, or drugs interfering with glucose and lipid metabolism or gonadal function (over the last 6 mo)
  • 5-alcoholism

研究者

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