TESTOSTERONE TREATMENT FOR MULTIPLE SCLEROSIS: A PRELIMINARY TRIAL

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。确定睾酮治疗男性多发性硬化（MS）患者的安全性和可能的疗效。与年轻女性相比，年轻男性的MS易感性降低。MS在男性中的发作与“男性更年期”的发作相关，并且在MS的动物模型中，与雌性小鼠相比，雄性小鼠中的疾病减少。雄性小鼠的疾病保护在去势后丧失，并且小鼠的睾酮治疗改善疾病。 虽然睾酮（T）先前已被证明是安全的，并且在性腺功能减退的男性中是耐受的，但尚未确定当将其给予男性MS患者时是否会发生积极或消极作用。这项研究将确定是否与睾酮治疗，给予经皮凝胶，是安全的，在男性MS患者的耐受性良好。MS是一种进行性疾病，随着时间的推移，通常会导致严重的残疾。唯一可以降低复发率的药物是注射药物。如果患者不耐受已批准的MS药物和/或拒绝注射，则与无治疗相比，参与本试验是一种良好的替代方案。由于本研究中没有接受安慰剂治疗的患者，因此确保每例患者都能接受治疗。除了睾酮治疗可能对MS疾病活动产生的任何可能的副作用外，很可能对肌肉质量和强度以及骨矿物质密度产生积极影响

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. To determine the safety and possible efficacy of treatment of male multiple sclerosis (MS) patients with testosterone. MS susceptibility is decreased in young men as compared to young women. The onset of MS in men correlates with the onset of "andropause" and in an animal model for MS the disease is decreased in males as compared to female mice. Disease protection in male mice is lost upon castration and testosterone treatment of mice ameliorates disease. While testosterone (T) has been previously shown to be safe and wll tolerated in hypogonadal males, it has not been determined if positive or negative effects will occur when it is given to male MS patients. This study will determine whether treatment with testosterone, given as a transdermal-gel, is safe and well tolerated in male MS patients. MS is a progressive disease in which significant disability often results over time. The only medication, which can reduce the relapse rate, are medications given by injection. If patients do not tolerate the approved drugs for MS and/or they refuse to take injections, then participating in this trial is a good alternative as to compared to no therapy. Since there are no placebo treated patients in this study, each patient is assured of getting treated. In addition to any possible side effects the testosterone treatment may have on MS disease activity, it is highly likely that positive effects on muscle mass and strength and bone mineral density will occur