ISRCTN29234515已完成未知
Ethinyloestradiol-Levonorgestrel versus Low-Dose Spironolactone-Pioglitazone-Metformin (SPIOMET) for Adolescent Girls with Polycystic Ovary Syndrome: On-Treatment and Post-Treatment Observations.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28712591 (added 29/01/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33782413/ (added 31/03/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •As of 21/07/2016:
- •1. Clinical androgen excess (hirsutism) and/or biochemical hyperandrogenismwith or without biochemical androgen excess
- •2. Chronological age between 14.0-17.9 years at study start
- •3. Gynecological age (= time post-menarche) >2.0 years at study start
- •4. Absence of sexual activity (intercourse)
- •1.Clinical and biochemical hyperandrogenism
- •2. Hyperinsulinemia (fasting and/or after an oGTT)
- •3. Age >14 and >18 year
- •4. Menarche at least 2 years before
- •5. BMI <97th percentile and >10th percentile
排除标准
- •As of 21/07/2016:
- •1. Evidence for adrenal hyperplasia, Cushing syndrome, hypothyroidism
- •2. Evidence for lLiver or kidney dysfunction, diabetes, glucose intolerance
- •3. Treatment with oral contraceptives, antiandrogens, or insulin sensitizers in past 6 months
- •1. Pregnancy or pregnancy risk
- •2. Late onset congenital adrenal hyperplasia, Cushing's syndrome, uncompensated hypothyroidism
- •3. Liver or renal dysfunction, diabetes, glucose intolerance
- •4. Treatment with oral contraceptives, antiandrogens, or insulin sensitizers over the previous 6 months
- •5. Severe bacterial infections
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