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
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Hypogonadism
Erectile Dysfunction
Interventions: Drug: Testim®
Other: Placebo Testim®
Drug: Viagra®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was approved for enrollment on 11/28/2007 and was closed on 1/25/13. Participants were consented in the Baylor Urology clinic setting.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Testim + Viagra Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
Placebo Testim + Viagra Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night

Participant Flow:   Overall Study
    Testim + Viagra     Placebo Testim + Viagra  
STARTED     2     1 [1]
COMPLETED     0     0  
NOT COMPLETED     2     1  
Screen failure                 2                 0  
Withdrawal by Subject                 0                 1  
[1] Completed Visit 4



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Arm 1 = 2 Arm 2 = 1

Reporting Groups
  Description
Arm 1 Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
Arm 2 Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  2     1     3  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     1     3  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  54  (4)     59  (0)     56  (4)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     2     1     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.   [ Time Frame: Basline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The subject that completed the study reported no adverse reactions or events.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mohit Khera, MD
Organization: Baylor College of Medicine
phone: 713-798-6593
e-mail: mkhera@bcm.edu


Publications:

Responsible Party: Mohit Khera, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00848497     History of Changes
Other Study ID Numbers: H-21148
Study First Received: February 19, 2009
Results First Received: March 18, 2013
Last Updated: June 2, 2015
Health Authority: United States: Food and Drug Administration