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Testosterone for Penile Rehabilitation After Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00848497
Recruitment Status : Terminated (Lack of volunteers who would consent to participate and lack of funding)
First Posted : February 20, 2009
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypogonadism Erectile Dysfunction Drug: Testim® Other: Placebo Testim® Drug: Viagra® Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)
Study Start Date : November 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Testim® + Viagra®
Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
 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 Name: Testim® is the brand name for testosterone gel.

Drug: Viagra®
Viagra 25mg was the dose given to the patient which he started.
Other Names:
  • Viagra® is the brand name for sildenafil citrate.
  • Viagra® 25 mg tablet daily at night
Placebo Comparator: Placebo Testim® + Viagra®
Placebo Testim® gel once daily + Viagra® 25 mg tablet every night
 Other: Placebo Testim®
Placebo Testim® 5 g of gel (one tube)
Other Name: Placebo Testim

Drug: Viagra®
Viagra 25mg was the dose given to the patient which he started.
Other Names:
  • Viagra® is the brand name for sildenafil citrate.
  • Viagra® 25 mg tablet daily at night


Outcome Measures
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Primary Outcome Measures :
  1. Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit. [ Time Frame: Baseline and 6 months ]
    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


Secondary Outcome Measures :
  1. Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit. [ Time Frame: Baseline and 6 months ]
    There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function

  2. Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit. [ Time Frame: Baseline and 6 months ]
    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.

  3. Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit. [ Time Frame: Basline and 6 months ]
    EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 (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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848497


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mohit Khera
Investigators
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Principal Investigator: Mohit Khera, MD Baylor College of Medicine
More Information
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Publications:

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Responsible Party: Mohit Khera, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00848497    
Other Study ID Numbers: H-21148
First Posted: February 20, 2009    Key Record Dates
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015
Last Verified: June 2015
Keywords provided by Mohit Khera, Baylor College of Medicine:
hormone replacement therapy
radical prostatectomy
erectile dysfunctions
scheduled for removal of prostate gland
Additional relevant MeSH terms:
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Erectile Dysfunction
Hypogonadism
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Sildenafil Citrate
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
 Molecular Mechanisms of Pharmacological Action
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents