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Testosterone for Penile Rehabilitation After Radical Prostatectomy

Primary Purpose

Hypogonadism, Erectile Dysfunction

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Testim®

Placebo Testim®

Viagra®

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring hormone replacement therapy, radical prostatectomy, erectile dysfunctions, scheduled for removal of prostate gland

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Testim® + Viagra®

Placebo Testim® + Viagra®

Arm Description

Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night

Placebo Testim® gel once daily + Viagra® 25 mg tablet every night

Outcomes

Primary Outcome Measures

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

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

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

There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function

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

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.

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

EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better

Full Information

NCT ID

NCT00848497

First Posted

February 19, 2009

Last Updated

June 2, 2015

Sponsor

Mohit Khera

1. Study Identification

Unique Protocol Identification Number

NCT00848497

Brief Title

Testosterone for Penile Rehabilitation After Radical Prostatectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

Lack of volunteers who would consent to participate and lack of funding

Study Start Date

November 2007 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mohit Khera

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism, Erectile Dysfunction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Testim® + Viagra®

Arm Type

Active Comparator

Arm Description

Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night

Arm Title

Placebo Testim® + Viagra®

Arm Type

Placebo Comparator

Arm Description

Placebo Testim® gel once daily + Viagra® 25 mg tablet every night

Intervention Type

Drug

Intervention Name(s)

Testim®

Other Intervention Name(s)

Testim® is the brand name for testosterone gel.

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo Testim®

Other Intervention Name(s)

Placebo Testim

Intervention Description

Placebo Testim® 5 g of gel (one tube)

Intervention Type

Drug

Intervention Name(s)

Viagra®

Other Intervention Name(s)

Viagra® is the brand name for sildenafil citrate., Viagra® 25 mg tablet daily at night

Intervention Description

Viagra 25mg was the dose given to the patient which he started.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline and 6 months

Secondary Outcome Measure Information:

Title

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

Description

There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function

Time Frame

Baseline and 6 months

Title

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

Description

Time Frame

Baseline and 6 months

Title

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

Description

EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better

Time Frame

Basline and 6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohit Khera, MD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19207277

Citation

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):1165-1170. doi: 10.1111/j.1743-6109.2009.01161.x. Epub 2009 Jan 22.

Results Reference

background

PubMed Identifier

17983894

Citation

Khera M, Lipshultz LI. The role of testosterone replacement therapy following radical prostatectomy. Urol Clin North Am. 2007 Nov;34(4):549-53, vi. doi: 10.1016/j.ucl.2007.08.007.

Results Reference

background

PubMed Identifier

19207279

Citation

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.

Results Reference

background

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Testosterone for Penile Rehabilitation After Radical Prostatectomy

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