A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
NCT ID: NCT00106392
Last Updated: 2010-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
131 participants
INTERVENTIONAL
2005-02-28
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Tacrolimus
Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
Tacrolimus
oral
Placebo
Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
Placebo
oral
Interventions
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Tacrolimus
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient has been diagnosed with Type 1 or Type 2 diabetes
* Patient is actively smoking on a daily basis
65 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma US, Inc
Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Ann Arbor, Michigan, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Countries
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References
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Mulhall JP, Klein EA, Slawin K, Henning AK, Scardino PT. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med. 2018 Sep;15(9):1293-1299. doi: 10.1016/j.jsxm.2018.07.009.
Related Links
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Link to prescribing information
Other Identifiers
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20-03-001
Identifier Type: -
Identifier Source: org_study_id