Testosterone for Penile Rehabilitation After Radical Prostatectomy

This study has been terminated.
(Lack of volunteers who would consent to participate and lack of funding)
Sponsor:
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00848497
First received: February 19, 2009
Last updated: June 2, 2015
Last verified: June 2015

February 19, 2009
June 2, 2015
November 2007
March 2013   (final data collection date for primary outcome measure)
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED
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
  • Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function
  • Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    ADAM scores of one evaluated patient. ADAM is 10 questions ("yes" or "no" answers) and if you answer yes to question 1 or 7 or "yes" to any 3 questions you are said to test "positive" to the ADAM questionnaire.
  • Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit. [ Time Frame: Basline and 6 months ] [ Designated as safety issue: No ]
    EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better
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 Rehabilitation 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.

There was only one patient who began treatment with the study drug. After blind was broken, it was noted that he received placebo Testim and Viagra.

Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hypogonadism
  • Erectile Dysfunction
  • Drug: Testim®
    Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily. This was the dose given to the patient which he started.
    Other Name: Testim® is the brand name for testosterone gel.
  • Other: Placebo Testim®
    Placebo Testim® 5 g of gel (one tube)
    Other Name: Placebo Testim
  • Drug: Viagra®
    Viagra 25mg was the dose given to the patient which he started.
    Other Names:
    • Viagra® is the brand name for sildenafil citrate.
    • Viagra® 25 mg tablet daily at night
  • Active Comparator: Testim® + Viagra®
    Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
    Interventions:
    • Drug: Testim®
    • Drug: Viagra®
  • Placebo Comparator: Placebo Testim® + Viagra®
    Placebo Testim® gel once daily + Viagra® 25 mg tablet every night
    Interventions:
    • Other: Placebo Testim®
    • Drug: Viagra®

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
March 2013
March 2013   (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 (Prostate-Specific Antigen) 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 information is only displayed when the study is recruiting subjects
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
June 2015

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