Testosterone for Penile Rehabilitation After Radical Prostatectomy

Erectile Dysfunction Clinical Trial

Official title:

Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00848497
• Other study ID #: H-21148
• Status: Terminated
• Phase: Phase 0
• First received: February 19, 2009
• Last updated: June 2, 2015
• Start date: November 2007
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hypogonadism

Intervention

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:
• Placebo Testim®
Placebo Testim® 5 g of gel (one tube)

Drug:
• Viagra®
Viagra 25mg was the dose given to the patient which he started.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mohit Khera

Country where clinical trial is conducted

United States, 

References & 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):1165-70. doi: 10.1111/j.1743-6109.2009.01161.x. Epub 2009 Jan 22. — View Citation

Khera M, Lipshultz LI. The role of testosterone replacement therapy following radical prostatectomy. Urol Clin North Am. 2007 Nov;34(4):549-53, vi. Review. — View Citation

Khera 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.	There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function	Baseline and 6 months	No
Secondary	Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.	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.	Baseline and 6 months	No
Secondary	Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.	EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better	Basline and 6 months	No