Ethynil-estradiol cyproterone acetate versus low-dose metformin-flutamide-pioglitazone in girls with hyperinsulinemic androgen excess: effects on parameters of chronic inflammation, and on risk factors for type 2 diabetes and cardiovascular disease

Hospital Sant Joan de Déu (Spain)0 个研究点目标入组 46 人开始时间: 2010年4月6日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Adolescent girls (14-17 yr)
•2. Two or more yr beyond menarche
•3. BMI less than the 97th centile for age
•4. Clinical and biochemical signs of androgen excess (hirsutism [Ferriman & Gallwey score >8] and/or acne and/or menstrual irregularities)
•5. Total testosterone >60 ng/dL and/or free androgen index >5
•6. Hyperinsulinism: fasting insulin >15 uU/mL; glucose/insulin ratio <7, or peak insulin after an OGTT >100 uU/m

•1. Pregnancy or pregnancy risk
•2. Late-onset congenital adrenal hyperplasia due to 21-OH deficiency
•3. Hyperprolactinemia
•4. Cushing's syndrome
•5. Hypothyroidism
•6. Abnormal liver or kidney function, Creatine Phosphokinase (CPK) or Lactate Dehydrogenase (LDH)
•6. Diabetes or impaired glucose tolerance
•7. Cutaneous allergies
•8. Treatment with anti-androgens, estroprogestagens, or medications interfering with lipid and carbohydrate metabolism during the previous 6 mo
•9. Bacterial infections
•10. Inflammatory intestinal conditions

发起方

Hospital Sant Joan de Déu (Spain)