EUCTR2012-002564-27-GB进行中（未招募）1 期
Pilot open study of testosterone replacement in non-alcoholic steatohepatitis - TEREPINS: Testosterone Replacement in Non-alcoholic Steatohepatitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
入选标准
- •Men will be recruited with hypogonadism and NAFLD based on all of:
- •1.Abnormal serum ALT on >2 occasions over at least 3 months, despite standard lifestyle advice when appropriate, in regard to moderation of alcohol intake, weight reduction and exercise.
- •2.Negative serological tests for hepatitis Bs ag and C antibody.
- •3.Alcohol consumption >21 units per week for no more than 2 week in the last year and for no more than 3 months of the past 5 years, assessed using a lifetime alcohol consumption questionnaire 44.
- •4.Liver biopsy, performed as part of clinical management within 6 months of recruitment, which shows all of: (a) steatosis (Kleiner grade 2 or 3)45; (b) NASH (combined intralobular inflammation and hepatocyte ballooning score of >1)45; (c) fibrosis Ishak stage <446; and (d) no evidence to suggest another major liver disease.
- •5.Hypotestosteronaemia, defined by total serum testosterone <11 ng/L40 . We predict that this will include about 25% of men with NAFLD as defined above.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1.Inability to give informed consent.
- •2.Age <18 or >75 years.
- •3.Symptomatic sexual dysfunction.
- •4.Cirrhosis either on baseline liver biopsy (Ishak score 5-6) or suggested by presence of varices, by ultrasound (small shrunken liver, ascites, splenomegaly) or by liver decompensation (encephalopathy, abnormal serum direct bilirubin, albumin or prothrombin time).
- •5.Space occupying lesion on ultrasound with any suspicion of malignancy.
- •6. Evidence of other chronic liver diseases pace occupying lesion on ultrasound with any suspicion of malignancy.
- •7. Prostatic nodule or mass on PR examination unless full urological examination rules our prostate cancer
- •8. Serum PSA or alpha feta protein above the age-specific normal range
- •9. Carcinoma of male breast
- •10.Taking medications (amiodarone, anti-retrovirals, sodium alproate, corticosteroids, tamoxifen) the previous 3 months (known to improve steatosis).
- •11.Diabetes or hyperlipidaemia, where therapy has been changed within the last 12 months or with suboptimal control anticipating the need for change in therapy during the study.
- •12.Severe or complicated obesity, likely requiring bariatric surgery in next 2 years.
- •13.LH/FSH levels, raising the possibility of primary pituitary disease.
- •14.Subject trying to or hoping to conceive within next 18 months.
- •15. Haematocrit of >0.54
- •16.History of any of the following: Sleep apnoea, breast or prostate or liver cancer, congestive heart failure, chronic renal failure (serum creatinine >150), severe chronic obstructive airways disease, uncontrolled hypertension epilepsy depression or migraine.
- •17.Severe co morbidity likely in the opinion of the investigators to reduce life expectancy to <10 years.
- •18. Hypersensitivity to active agent or to any of the excipients.
- •Patients in whom H-MRS is contraindicated (e.g. due to a pacemaker) will be eligible for the trial but H-MRS will not be performed with those participants.
研究者
相似试验
招募中
不适用
Clinical trial of testosterone replacement therapy for the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor.JPRN-UMIN000033962Department of Metabolic Medicine. Osaka University Graduate School of Medicine30
招募中
3 期
Testosterone therapy for the treatment of nonalcoholic fatty liver diseaseNonalcoholic fatty liver diseaseACTRN12619000701123Austin Health120
已完成
4 期
Testosterone for gender dysphoria in transgender meDepressionTransgender healthGender dysphoriaSuicideMetabolic and Endocrine - Other endocrine disordersMental Health - DepressionMental Health - SuicideACTRN12621000716864niversity of Melbourne64
招募中
Unknown
Effect of testosterone replacement associated with bariatric surgery in men with obesityObesityRBR-9qks3pcHospital e Maternidade São Domingos
已完成
不适用
Monitoring testosterone replacement therapy - a strategy for distinguishing real and falsely high concentrations of testosterone.NL-OMON51953Vrije Universiteit Medisch Centrum5