Testosterone for Penile Rehab After Radical Prostatectomy - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00848497

Purpose

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. Men scheduled for surgery to remove the prostate will be given the opportunity to take part in this study. Before surgery, subjects will complete questionnaires and have blood drawn. 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 surgery and will take study drug for 3 months only. Office visits will be the 3, 6, 9, and 12 month visits. Participation will end at the end of the 12-month visit.

Condition	Intervention	Phase
Low Testosterone Levels Erectile Dysfunction	Drug: Testim® + Viagra® Drug: Placebo Testim® + Viagra®	Phase 0

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction Rehabilitation Surgery

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Citric acid Sildenafil Sildenafil citrate Oxymesterone Testosterone enanthate Sodium Citrate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Drug: Testim® + Viagra® Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily and Viagra® 25 mg tablet daily at night
2: Placebo Comparator Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night	Drug: Placebo Testim® + Viagra® Placebo Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily and Viagra® 25mg every night Viagra® = 25 mg tablet daily at night

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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 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.
Pre-operative SHIM score less than 17. SHIM is a section within the International Index of Erectile Function (IIEF) questionnaire.
Positive surgical margins or evidence of residual prostate cancer.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848497

Contacts

Contact: Sharon Harrison

713-798-2240

sharons@bcm.edu

Locations

United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Sub-Investigator: Larry I. Lipshultz, MD

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Mohit Khera, MD

Baylor College of Medicine

More Information

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 Jan 22; [Epub ahead of print]

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 Jan 21; [Epub ahead of print]

Responsible Party:	Baylor College of Medicine ( Mohit Khera, MD )
Study ID Numbers:	H-21148
Study First Received:	February 19, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00848497 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:

hormone replacement therapy
radical prostatectomy
erectile dysfunctions
scheduled for removal of prostate gland

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Antineoplastic Agents, Hormonal
Hormone Antagonists
Citric Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Sildenafil
Cardiovascular Agents
Methyltestosterone
Genital Diseases, Male

Hormones
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders
Citrate
Erectile Dysfunction
Androgens

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Methyltestosterone
Genital Diseases, Male

Sexual and Gender Disorders
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders
Therapeutic Uses
Erectile Dysfunction
Androgens

ClinicalTrials.gov processed this record on August 30, 2009