Testosterone for Penile Rehab After Radical Prostatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00848497
First received: February 19, 2009
Last updated: October 24, 2012
Last verified: October 2012
  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. 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.


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

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

Resource links provided by NLM:


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 after initial screening visit. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure includes the change in the IIEF, ADAM and EPIC scores 6 months after the initial screening visit. [ Time Frame: 6 months ] [ 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
Active Comparator: 1
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
Other Names:
  • Testim® Testim® is the brand name for testosterone gel.
  • Viagra® is the brand name for sildenafil citrate.
Placebo Comparator: 2
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

Other Name: Viagra® is the brand name for sildenafil citrate.

  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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mohit Khera
Investigators
Principal Investigator: Mohit Khera, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Mohit Khera, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00848497     History of Changes
Other Study ID Numbers: H-21148
Study First Received: February 19, 2009
Last Updated: October 24, 2012
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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Sildenafil
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014