Testosterone for Penile Rehabilitation After Radical Prostatectomy

June 2, 2015 updated by: Mohit Khera

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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
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
Other: Placebo Testim®
Placebo Testim® 5 g of gel (one tube)
Other Names:
  • Placebo Testim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 6 months
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.
Baseline and 6 months
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
Basline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohit Khera

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (ESTIMATE)

February 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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