DRKS00005485进行中（未招募）4 期
ate-onset hypogonadism (LOH) and depressive mood changes - a double blind, placebo-controlled study with intramuscular application of testosterone undecanoate - TeLoDe12
Marin-Luther-Universität Halle-Wittenberg0 个研究点目标入组 1 人开始时间: 2014年5月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 one（—）
- 性别
- Male
入选标准
- •written informed consent; men with age at least 60 years; confirmed late-onset hypogonadism (according to International Society of Andrology 2009); confirmed depressive mood (ICD10 F32.0 - F32.1); either total testosterone level < 12 nmol/l or free testosterone < 225 pmol/l; score GDS-30 >= 13 (within last week)
排除标准
- •taking of Androgens or Anabolics within last 12 months; PSA = 4 ng/ml; pathological finding of prostate (DRE); diagnose or suspicion of tumor of prostate, mamma and liver; Major Depression (ICD10 F32.2 - F32.3); known dementia;known abuse of alcohol and drugs;
- •other known psychiatric disease (psychiatric examination) or psychotherapy; BDI-II >=20, item 9 BDI-II (suicidality) >=1); acute or life-threatening disease (estimated expectancy of life < 2 years); chronic disease, possibly affecting security of patient during study (e.g. Haemochromatosis, Dubin-Johnson-Rotor-Syndrome, chronic disease of lung;
- •Hypersensitivity against IMP or substances of IMP; problems of coagulation with increased risk of bleeding after injection; sleep apnea; Polycythaemia; Haematocrit > 50 %; taking of 5a-Reductase-Inhibitors; Prolactin > 25 ng/ml; benign hyperplasia of prostate with obstruction of bladder neck (residual urine > 200 ml); BMI > 35 kg/m²; untreated dysfunction of thyroid gland; untreated Diabetes mellitus (HbA1C > 9%); untreated Epilepsy; untreated Migaine; planned or actual therapy for reproduction; psychiatric or other disease to hinder the patient to understand content of study; unsufficient treatment of hypertension; known insufficiency of heart, liver and kidney; unsufficient treatment of coronary heart disease; known or actual thrombotic event; participation on other clinical trials; taking of Androgens, Anabolics, Clomipramin, Antiandrogens, Estrogens; Corticotropinen (ACTH); Oxyphenbutazon; psychotropic drugs
研究者
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