PH II & III: (DHT) GEL FOR HORMONAL REPLACEMENT HYPOGONADAL MEN

PH II

• 批准号: 6302920
• 负责人: THOMAS J WEBER
• 金额: $ 4.09万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6302920
• 关键词: blood chemistry; clinical research; dihydrotestosterone; gel; hormone therapy; human old age (65+); human subject; human therapy evaluation; hypogonadism; male; prostate specific antigen; reproductive system disorder chemotherapy; topical drug application

The purpose of the study is to evaluate the effectiveness and safety of dermally applied DHT Gel preparation in elderly hypogonadal men. Effectiveness will be determined on basis of circulating androgen levels (DHT + T) and pharmacological response to DHT (gonadotropin suppression, effects on bone formation markers, muscle strength, body composition and libido) compared to patients using placebo gel. Data received from this study will be used to establish DHT Gel doses in a future phase III study of elderly hypogonadal men. The hypothesis to be tested is that this novel androgen gel preparation may provide safer and equally effective therapy for elderly men with hypogonadism than is currently available. Patients will be monitored for testosterone changes as well as other levels such as gondotropins, estradiol, prolactin, lipid panel, chemistry tests and blood hematology. Prostate evaluation will be performed by rectal examination in addition to prostate ultrasound plus prostate specific antigen level. Bone density studies, body composition, muscle strength testing and urine flow rate will be monitored. Questionnaires will be filled out by the patient regarding mood and sexual function. Patients eligible for the study will be males above the age of 60 who have been diagnosed with testosterone deficiency requiring testosterone replacement. Selected patients should be in good health as determined by medical history and physical examination, with no pre-existing prostate abnormalities. Patients will undergo screening to confirm they meet criteria for the protocol. Patients will be randomized to one of three doses of gel: Group A will receive 32 mg DHT-gel, Group B will receive 64 mg DHT-gel and Group C will receive placebo. Gel will be applied to multiple sites. Duration of drug exposure will be 90 days. Patients will be monitored on day 0, day 1, day 30, day 60, and day 90. The significance of this study is that the gel will provide an easier delivery system compared to currently available forms of androgen replacement. The new gel formulation allows a measured does to be given and rubbed on the skin by the patient. Future plans include an extension phase to study the long-term effectiveness and safety of DHT-gel as a means to provide androgen replacement in elderly, hypogonadal men. The extension period will allow for evaluation and treatment for an additional 24 months.

本研究的目的是评价双氢睾酮凝胶制剂皮肤应用于老年性腺功能减退男性的有效性和安全性。将根据与使用安慰剂凝胶的患者相比的循环雄激素水平（DHT + T）和对DHT的药理学反应（促性腺激素抑制、对骨形成标志物、肌肉力量、身体组成和性欲的影响）确定有效性。 从本研究中获得的数据将用于确定未来老年性腺功能减退男性III期研究中的DHT凝胶剂量。 有待检验的假设是，这种新型雄激素凝胶制剂可能为老年男性性腺功能减退症提供比目前更安全和同样有效的治疗。 将监测患者的睾酮变化以及其他水平，如促性腺激素、雌二醇、催乳素、血脂、生化检查和血液学。 除了前列腺超声加前列腺特异性抗原水平外，还将通过直肠检查进行前列腺评估。 将监测骨密度研究、身体成分、肌力测试和尿流率。患者将填写有关情绪和性功能的表格。 符合研究条件的患者将是60岁以上的男性，他们被诊断患有睾酮缺乏症，需要睾酮替代。 选定的患者应通过病史和体格检查确定健康状况良好，无预先存在的前列腺异常。 患者将接受筛选，以确认其符合方案标准。 患者将被随机分配至三种剂量的凝胶中的一种：A组将接受32 mg DHT-凝胶，B组将接受64 mg DHT-凝胶，C组将接受安慰剂。 凝胶将应用于多个部位。 药物暴露持续时间为90天。将在第0天、第1天、第30天、第60天和第90天监测患者。这项研究的意义在于，与目前可用的雄激素替代形式相比，凝胶将提供更容易的递送系统。新的凝胶配方允许测量剂量，并由患者在皮肤上摩擦。 未来的计划包括一个扩展阶段，以研究DHT凝胶作为老年性腺功能减退男性雄激素替代治疗的长期有效性和安全性。 延长期将允许额外24个月的评估和治疗。