ISRCTN70274195已完成3 期
Testosterone Replacement in Young Male cancer Survivors: a prospective, multicentre, randomised, double-blinded, parallel-group, placebo-controlled phase III trial
Sheffield Teaching Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 136 人开始时间: 2011年5月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31714912 (added 15/11/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Able and willing to comply with all study procedures
- •2. Able to provide written informed consent
- •3. Male, aged between 25 and 50 years
- •4. Post-pubertal
- •5. Previous testicular cancer, lymphoma or leukaemia
- •6. At least 12 months from completion of curative treatment for testicular cancer, lymphoma or leukaemia
- •7. A serum testosterone level =7 nmol/l and =12 nmol/l
- •8. Taking any hormone replacement, on stable doses for the last 6 months
排除标准
- •1. Body Mass Index (BMI) of more than 35 kg/m2
- •2. Currently receiving corticosteroid therapy or likely to receive corticosteroids during the trial
- •3. Previous testosterone treatment within 12 months of entering the trial
- •4. Previous allogeneic bone marrow transplant
- •5. A history of hormone-dependent cancer (e.g., prostate or breast cancer)
- •6. A history of primary liver tumour
- •7. Hypercalcaemia
- •8. Nephrotic syndrome
- •9. Diabetes
- •10. Other severe concurrent disease or mental disorders which would affect the collection of study measurements
研究者
相似试验
进行中（未招募）
1 期
Testosterone replacement in young male cancer survivorsBorderline low levels of testosterone in male cancer survivors who have previously had leukaemia, lymphoma or testicular cancer.MedDRA version: 14.0Level: LLTClassification code 10047900Term: Weight lossSystem Organ Class: 10022891 - InvestigationsEUCTR2011-000677-31-GBSheffield Teaching Hospitals NHS Foundation Trust268
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
进行中（未招募）
1 期
The effect of testosterone replacement threapy in men using opioidsEUCTR2014-004729-42-DKOdense University Hospital, department M40
进行中（未招募）
不适用
Male sex hormone therapy to young males with hormone deficiency: 2 years, double-blind, placebo controlled studyEUCTR2011-004266-15-NOniversity Hospital of North Norway160
进行中（未招募）
不适用
Male sex hormone therapy to young males with hormone deficiency: 2 years, double-bld, placebo controlled studyTarget population: Male hypogonadism (testosterone deficiency)As end pointsBone mineralisationBody compositionMarkers of insulin sensitivity and cardiovascular diseaseLipid profileHemoglobin concentration amd hematocritMedDRA version: 14.1Level: LLTClassification code 10067734Term: Testosterone deficiencySystem Organ Class: 10014698 - Endocrine disordersEUCTR2011-004266-15-SERMC, Skåne University Hospital160