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Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease Clinical research trials and Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease. Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease clinical trial. Participants frequently get the best healthcare available for their Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

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Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease



Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease

For Condition: Amyotrophic Lateral Sclerosis,Spinobulbar Muscular Atrophy,Spinal Muscular Atrophy
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Ohio State University
Synopsis: OBJECTIVES: I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.
Details: PROTOCOL OUTLINE: All patients receive androgen suppression with leuprolide acetate injections every 4 weeks for 6 months, plus hormone replacement therapy with testosterone enanthate injections every week for 24 weeks.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Men aged 18 and over with motor neuron disease, i.e.: - X-linked spinal and bulbar muscular atrophy (Kennedy's disease) - Confirmed by androgen receptor, exon-1 mutation genotype - Amyotrophic lateral sclerosis - Spinal muscular atrophy Significant muscle weakness on manual muscle testing No prisoners No mental disability
Total Enrollment: 40

Location and Contact Information:

Overall Study Official:
JerryMendell,  Study Chair,  Ohio State University


Additional Information:
Study ID Numbers:
  199/11792;  OSU-92H0325
Study Start Date: October 1992
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004771

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