A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00106392
First received: March 23, 2005
Last updated: November 15, 2010
Last verified: November 2010

March 23, 2005
November 15, 2010
February 2005
April 2008   (final data collection date for primary outcome measure)
Erectile Function Domain Score Between Treated and Untreated Groups [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.
The primary endpoint will be the difference in the erectile function domain score between treated and untreated groups
Complete list of historical versions of study NCT00106392 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

    Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months.

  • Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.
  • Percentage of Patients Considered Successful Responders to Impotence Medications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.
  • Time to Achieve Response to Impotence Medications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.
  • Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.
The percentage of patients achieving normal spontaneous erectile function
Not Provided
Not Provided
 
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Erectile Dysfunction
  • Prostate Cancer
  • Drug: Tacrolimus
    oral
    Other Name: Prograf, FK506
  • Drug: Placebo
    oral
  • Experimental: 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.
    Intervention: Drug: Tacrolimus
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
November 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Exclusion Criteria:

  • Patient is > 65 years of age
  • Patient has been diagnosed with Type 1 or Type 2 diabetes
  • Patient is actively smoking on a daily basis
Male
up to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106392
20-03-001
Yes
Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Astellas Pharma US, Inc.
Astellas Pharma Inc
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP