Study Stopped
Lack of volunteers who would consent to participate and lack of funding
Testosterone for Penile Rehabilitation After Radical Prostatectomy
Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)
1 other identifier
interventional
3
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Nov 2007
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
June 19, 2015
CompletedJune 19, 2015
June 1, 2015
5.3 years
February 19, 2009
March 18, 2013
June 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
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
Baseline and 6 months
Secondary Outcomes (3)
Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.
Baseline and 6 months
Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
Baseline and 6 months
Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
Basline and 6 months
Study Arms (2)
Testim® + Viagra®
ACTIVE COMPARATORTestim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Placebo Testim® + Viagra®
PLACEBO COMPARATORPlacebo Testim® gel once daily + Viagra® 25 mg tablet every night
Interventions
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.
Placebo Testim® 5 g of gel (one tube)
Viagra 25mg was the dose given to the patient which he started.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mohit Kheralead
Study Sites (1)
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (3)
Khera M, Grober ED, Najari B, Colen JS, Mohamed O, Lamb DJ, Lipshultz LI. Testosterone replacement therapy following radical prostatectomy. J Sex Med. 2009 Apr;6(4):1165-1170. doi: 10.1111/j.1743-6109.2009.01161.x. Epub 2009 Jan 22.
PMID: 19207277BACKGROUNDKhera M, Lipshultz LI. The role of testosterone replacement therapy following radical prostatectomy. Urol Clin North Am. 2007 Nov;34(4):549-53, vi. doi: 10.1016/j.ucl.2007.08.007.
PMID: 17983894BACKGROUNDKhera M. Androgens and erectile function: a case for early androgen use in postprostatectomy hypogonadal men. J Sex Med. 2009 Mar;6 Suppl 3:234-8. doi: 10.1111/j.1743-6109.2008.01159.x. Epub 2009 Jan 21.
PMID: 19207279BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The subject that completed the study reported no adverse reactions or events.
Results Point of Contact
- Title
- Mohit Khera, MD
- Organization
- Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Mohit Khera, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 20, 2009
Study Start
November 1, 2007
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
June 19, 2015
Results First Posted
June 19, 2015
Record last verified: 2015-06