DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Testosterone for Penile Rehabilitation After Radical Prostatectomy

Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism; Erectile Dysfunction

Intervention: Testim® (Drug); Placebo Testim® (Other); Viagra® (Drug)

Phase: Phase 0

Status: Terminated

Sponsored by: Mohit Khera

Official(s) and/or principal investigator(s):
Mohit Khera, MD, Principal Investigator, Affiliation: Baylor College of Medicine

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.

Clinical Details

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

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

Primary outcome: Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.

Secondary outcome:

Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.

Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.

Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Baylor College of Medicine, Houston, Texas 77030, United States
Additional Information

Related publications:

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.

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.

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.

Starting date: November 2007
Last updated: June 2, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017