Testosterone for Penile Rehabilitation After Radical Prostatectomy

• Sponsor: Mohit Khera (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00848497
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 64
• Patients Per Site Per Month: 0

Study Details

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.

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

• Study Type: Interventional
• 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: Nov 1, 2007
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

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	Other: Placebo Testim®; Placebo Testim® 5 g of gel (one tube); Other Names: 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

Primary Outcome Measures

1. Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit. [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. [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. [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. [Basline and 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77030

Sponsors and Collaborators

• Mohit Khera

Investigators

• Principal Investigator: Mohit Khera, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

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 Apr;6(4):1165-1170. doi: 10.1111/j.1743-6109.2009.01161.x. Epub 2009 Jan 22.
• 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 Mar;6 Suppl 3:234-8. doi: 10.1111/j.1743-6109.2008.01159.x. Epub 2009 Jan 21. Review.

• Responsible Party: Mohit Khera, Assistant Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00848497
• Other Study ID Numbers: H-21148
• First Posted: Feb 20, 2009
• Last Update Posted: Jun 19, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Mohit Khera, Assistant Professor, Baylor College of Medicine: hormone replacement therapy; radical prostatectomy; erectile dysfunctions; scheduled for removal of prostate gland
• Additional relevant MeSH terms: Erectile Dysfunction; Hypogonadism; Methyltestosterone; Sildenafil Citrate; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

Participant Flow

Recruitment Details	The study was approved for enrollment on 11/28/2007 and was closed on 1/25/13. Participants were consented in the Baylor Urology clinic setting.

Arm/Group Title	Testim + Viagra	Placebo Testim + Viagra
Arm/Group Description	Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Period Title: Overall Study
STARTED	2	1
COMPLETED	0	0
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Total
Arm/Group Description	Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night	Total of all reporting groups
Overall Participants	2	1	3
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	1 100%	3 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54 (4)	59 (0)	56 (4)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	1 100%	3 100%
Region of Enrollment (participants) [Number]
United States	2 100%	1 100%	3 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Baseline = 0 5 months = 0

Arm/Group Title	Testim + Viagra	Placebo Testim + Viagra
Arm/Group Description	Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night SHIM at Baseline = N/A SHIM at 5 months = N/A	Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night SHIM at Baseline = 0 SHIM at 5 months = 0
Measure Participants	0	1
Number [units on a scale]	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Baseline = 5 5 months = 6

Arm/Group Title	Testim + Viagra	Placebo Testim + Viagra
Arm/Group Description	Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Measure Participants	0	1
Number [units on a scale]	1

3. Secondary Outcome

Title	Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
Description	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.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Baseline = Positive 5 months = Positive

Arm/Group Title	Testim + Viagra	Placebo Testim + Viagra
Arm/Group Description	Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Measure Participants	0	1
Number [number of yes answers]	1

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Baseline = 98 5 months = 87

Arm/Group Title	Testim + Viagra	Placebo Testim + Viagra
Arm/Group Description	Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Measure Participants	0	1
Number [units on a scale]	-11

Adverse Events

Time Frame	6 months
Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night		Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)

Limitations/Caveats

The subject that completed the study reported no adverse reactions or events.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.