International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,493
- 主要终点
- Adverse events, adverse drug reactions, patient reported tolerability
研究概览
简要总结
This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization
排除标准
- •Patients presenting with contraindications as stated in the product information
研究组 & 干预措施
Group 1
干预措施: Testosterone Undecanoate (Nebido, BAY86-5037) (Drug)
结局指标
主要结局
Adverse events, adverse drug reactions, patient reported tolerability
时间窗: during 4 injection intervals
次要结局
- Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation(after 4 injection intervals)
- Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation(after 4 injection intervals)
- Change in intensity of symptoms or disorders associated with low testosterone (hot flushes or excessive sweating, sleep disturbances, decreased physical strength and erectile dysfunction) from baseline to end of observation(after 4 injection intervals)
- Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)(after 4 injection intervals)
- Treatment continuation rate(after 4 injection intervals)
- Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)(during 4 injection intervals)
- Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)(during 4 injection intervals)
- Digital rectal examination(during 4 injection intervals)