Trial Outcomes & Findings for Testosterone for Penile Rehabilitation After Radical Prostatectomy (NCT NCT00848497)

Results Overview

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

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

3 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2015-06-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Testim + Viagra Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Placebo Testim + Viagra Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Overall Study STARTED	2	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Testim + Viagra Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Placebo Testim + Viagra Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Overall Study Screen failure	2	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Testosterone for Penile Rehabilitation After Radical Prostatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=2 Participants Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night	Arm 2 n=1 Participants Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 4 • n=5 Participants	59 years STANDARD_DEVIATION 0 • n=7 Participants	56 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Baseline = 0 5 months = 0

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

Outcome measures

Outcome measures
Measure	Testim + Viagra 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 + Viagra n=1 Participants Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night SHIM at Baseline = 0 SHIM at 5 months = 0
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.	—	0 units on a scale

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Baseline = 5 5 months = 6

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

Outcome measures

Outcome measures
Measure	Testim + Viagra 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 + Viagra n=1 Participants Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night SHIM at Baseline = 0 SHIM at 5 months = 0
Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.	—	1 units on a scale

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Baseline = Positive 5 months = Positive

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.

Outcome measures

Outcome measures
Measure	Testim + Viagra 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 + Viagra n=1 Participants Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night SHIM at Baseline = 0 SHIM at 5 months = 0
Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.	—	1 number of yes answers

SECONDARY outcome

Timeframe: Basline and 6 months

Population: Baseline = 98 5 months = 87

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

Outcome measures

Outcome measures
Measure	Testim + Viagra 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 + Viagra n=1 Participants Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night SHIM at Baseline = 0 SHIM at 5 months = 0
Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.	—	-11 units on a scale

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mohit Khera, MD

Baylor College of Medicine

Phone: 713-798-6593

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place