Ethinylestradiol-levonorgestrel versus spironolactone-pioglitazone-metformin (SPIOMET) for adolescent girls with hyperinsulinemic androgen excess: effects on hepatic and visceral fat and on insulin sensitivity

Hospital Sant Joan de Deu, University of Barcelona0 个研究点目标入组 41 人开始时间: 2015年9月21日最近更新: 2022年8月29日

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32342022/ results (added 07/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33782413/ (added 31/03/2021) 2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28712591/ Primary results (added 12/08/2022)

•1. Hyperinsulinemia, defined as fasting insulinemia >15 IU/mL and/or a peak insulinemia >150 IU/mL and/or mean insulinemia >84 IU/mL on a 2-hour oral glucose tolerance test (oGTT)
•2. Presence of both clinical and endocrine androgen excess, as defined by hirsutism score >8 (Ferriman-Gallwey scale), amenorrhea (no menses for more than 3 months) or oligomenorrhea (menstrual intervals >45 days), and high circulating concentrations of testosterone in the follicular phase (cycle day 3-7) or after 2 months of amenorrhea

•1. Pregnancy risk (throughout the study)
•2. Anemia or bleeding disorder
•3. Evidence of thyroid, liver or kidney dysfunction; abnormal electrolytes
•4. Hyperprolactinemia
•5. 21-hydroxylase deficiency (17-hydroxyprogesterone levels = 200 ng/dL in the follicular phase or after two months of amenorrhea)
•6. Glucose intolerance or diabetes mellitus
•7. Use of medication affecting gonadal or adrenal function, or carbohydrate or lipid metabolism

发起方

Hospital Sant Joan de Deu, University of Barcelona