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

PH II

• 批准号: 6415257
• 负责人: THOMAS J WEBER
• 金额: $ 29.31万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-12-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6415257
• 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

PURPOSE: 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. 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. METHODS: 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. 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. RESULTS AND CONCLUSIONS: The study is ongoing and results and conclusions are not available at this time. No adverse events related to the study drug have occurred. SIGNIFICANCE OF THE STUDY AND FUTURE PLANS: 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.

目的：本研究的目的是评价DHT凝胶制剂在老年男性性腺功能减退中的有效性和安全性。与使用安慰剂凝胶的患者相比，疗效将根据循环雄激素水平(DHT+T)和对DHT的药理反应(促性腺激素抑制、对骨形成标记物、肌肉力量、身体成分和性欲的影响)来确定。有待检验的假设是，这种新型雄激素凝胶制剂可能会为患有性腺功能减退的老年男性提供比目前可用的更安全和同样有效的治疗方法。方法：符合研究条件的患者将是60岁以上的男性，他们被诊断为睾酮缺乏症，需要睾酮替代治疗。根据病史和体格检查，入选的患者应健康状况良好，无前列腺病史。患者将接受筛查，以确认他们符合方案的标准。患者将被随机分配到三种剂量的凝胶中：A组服用32 mg双羟色胺凝胶，B组服用mg双羟色胺凝胶，C组服用安慰剂。凝胶将应用于多个部位。接触毒品的时间为90天。患者将在第0天、第1天、第30天、第60天和第90天接受监测。患者将接受睾酮变化以及其他水平的监测，如促性腺激素、雌二醇、催乳素、脂类、化学测试和血液学。除了前列腺超声和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、肌肉力量测试和尿流率。患者将填写有关情绪和性功能的问卷。结果和结论：这项研究正在进行中，目前还没有结果和结论。没有发生与研究药物有关的不良事件。这项研究的意义和未来的计划：这项研究的意义在于，与目前可用的雄激素替代形式相比，这种凝胶将提供更容易的给药系统。这种新的凝胶配方允许患者服用适量的剂量并在皮肤上摩擦。未来的计划包括一个扩展阶段，研究DHT-Gel作为一种手段在老年性腺功能低下男性中提供雄激素替代的长期有效性和安全性。延长期限将允许评估和治疗再延长24个月。