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Testosterone for Penile Rehab After Radical Prostatectomy

This study is currently recruiting participants.
Verified October 2012 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00848497
First received: February 19, 2009
Last updated: October 24, 2012
Last verified: October 2012
History of Changes

February 19, 2009
October 24, 2012
November 2007
November 2012   (final data collection date for primary outcome measure)
The primary outcome of the study is to evaluate efficacy of testosterone replacement therapy (TRT) in men following radical prostatectomy in improving erectile function using the change in SHIM score at 6 months after initial screening visit. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome of the study is to evaluate efficacy of testosterone replacement therapy (TRT) in men following radical prostatectomy in improving erectile function using the change in SHIM score at 6 months and 1 year after surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00848497 on ClinicalTrials.gov Archive Site
The secondary outcome measure includes the change in the IIEF, ADAM and EPIC scores 6 months after the initial screening visit. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The secondary outcome measure includes the change in the IIEF, ADAM and EPIC scores 1 year after surgery, the improvement trend in SHIM, IIEF, ADAM and EPIC scores over the 6 month and 12 months follow-up period. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Testosterone for Penile Rehab After Radical Prostatectomy
Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)

The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.

Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.
Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Low Testosterone Levels
  • Erectile Dysfunction
  • Drug: Testim® + Viagra®
    Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily and Viagra® 25 mg tablet daily at night
    Other Names:
    • Testim® Testim® is the brand name for testosterone gel.
    • Viagra® is the brand name for sildenafil citrate.
  • Drug: Placebo Testim® + Viagra®

    Placebo Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily and Viagra® 25mg every night

    Viagra® = 25 mg tablet daily at night

    Other Name: Viagra® is the brand name for sildenafil citrate.
  • Active Comparator: 1
    Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
    Intervention: Drug: Testim® + Viagra®
  • Placebo Comparator: 2
    Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
    Intervention: Drug: Placebo Testim® + Viagra®

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
November 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males, 18 years of age or older, with low testosterone levels.
  • Must have undergone a bilateral nerve sparing radical prostatectomy.
  • Nadir PSA values should be less than 0.01 ng/ml on two consecutive occasions separated by 4 weeks at the start of treatment.
  • Must give informed consent.
  • Must be willing to complete follow-up visits.

Exclusion Criteria:

  • Testosterone level greater than 300 ng/ dl
  • Hemoglobin level greater than 18 ng/dl.
  • Positive surgical margins or evidence of residual prostate cancer after surgery.
  • Clinically suspected advanced disease or actual evidence of metastatic prostate cancer.
  • Primary Gleason Grade greater than 3 or secondary Gleason Grade greater than 4 in the final pathologic specimen will be excluded.
  • Taking nitrates or with contraindications to the use of Viagra or androgen therapy will be excluded.
  • Known hypersensitivity to any component of the tablet will be excluded.
Male
18 Years and older
No
Contact: Sharon Harrison 713-798-2240 sharons@bcm.edu
United States
 
NCT00848497
H-21148
Yes
Mohit Khera, Baylor College of Medicine
Mohit Khera
Not Provided
Principal Investigator: Mohit Khera, MD Baylor College of Medicine
Baylor College of Medicine
October 2012

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