Phase IV Study of The Therapy of Long-acting Testosterone Undecanoate,1000mg in 4 ml Oily Solution for i.m.Injection(Nebido) as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Response of treatment for 4 injections at 1 year; score on an IIEF-5
研究概览
简要总结
The purpose of this study is to evaluate the response of a treatment with testosterone undecanoate and determine the levels of total and free testosterone in hypogonadal patients with erectile dysfunction.
详细描述
Hypogonadism is a pathophysiologic and clinical factor in a substantial number of patients with ED,and data indicate that a threshold level of testosterone is necessary for normal erectile function.Testosterone therapy is clearly indicated in hypogonadal patients and is beneficial in other patients with ED and hypogonadism.However,testosterone efficacy as monotherapy for ED could be limited,and combination therapy with testosterone and other ED treatments,such as PDE-5 inhibitors may be valuable in certain subpopulations of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with ED over 3 months (specify using IIEF score)
- •Age >= 18 years.
- •Stable sexual relationship
- •With low or low normal serum testosterone level (either total or bioavailable testosterone) TT <= 4 ng/ml and/or BT <= 1 ng/ml
- •Aging Male Symptom scale with total score starting at 37 points (must not replace TT < 4 ng/ml)
- •Eligible subjects who previously took the oral androgen or PDE5 inhibitor must have discontinued their use for 1 month
排除标准
- •Contraindication to treatment with Testosterone according to the SPC
- •Hypersensitivity to the active substances or any of the excipients of Nebido
- •Diagnosed or suspected carcinoma of the prostate or the male breast cancer
- •Past or present liver tumors
- •Acute or chronic hepatic diseases
- •Severe cardiac, hepatic or renal insufficiency
- •History of penile implant or significant penile deformity
- •Diagnosed sleep apnea
- •Polycythemia (Hematocrit >50%)
- •Prolactin >25 ng/ml
- •Organic hypothalamic-pituitary pathology
- •Any unstable medical, psychiatric or drug/alcohol abuse disorder
- •Prostate specific antigen (PSA)>= 4 ng/ml
- •Severe symptomatic benign prostatic hyperplasia (IPSS) sum score >=20)
- •Diabetes mellitus which is uncontrolled (HbAlc level >10%)
- •Epilepsy not adequately controlled by treatment
- •Patients requiring fertility treatment
- •Hypertension which is not adequately controlled on therapy
- •Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia
- •Hypersensitivity to PDE-5 inhibitors
- •Concomitant Medication:
- •Nitrites or Nitric oxide donors
- •Anti-androgens
- •anti-coagulants, with the exception of anti-platelet agents
- •Any of potent inhibitors of cytochrome P-450 3A4:such as HIV protease inhibitors (Ritonavir or Indinavir); Anti-mycotic agent (Itraconazole and Ketoconazole)-topical application allowed; or Erythromycin.
结局指标
主要结局
Response of treatment for 4 injections at 1 year; score on an IIEF-5
时间窗: 4 injections at 1 year for each subject, at 12,30,46 weeks.
次要结局
- Testosterone level(at 6,12,18,36,46 weeks)