Erectile Dysfunction, Hypogonadism
Conditions
Keywords
hormone replacement therapy, radical prostatectomy, erectile dysfunctions, scheduled for removal of prostate gland
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.
Interventions
DRUGTestim®
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.
OTHERPlacebo Testim®
Placebo Testim® 5 g of gel (one tube)
DRUGViagra®
Viagra 25mg was the dose given to the patient which he started.
Sponsors
Mohit Khera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night | 2 |
| Arm 2 Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen failure | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 0 | 54 years STANDARD_DEVIATION 4 | 56 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
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
Time frame: Baseline and 6 months
Population: Baseline = 0 5 months = 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Testim + Viagra | Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit. | 0 units on a scale |
Secondary
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.
Time frame: Baseline and 6 months
Population: Baseline = Positive 5 months = Positive
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Testim + Viagra | Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit. | 1 number of yes answers |
Secondary
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
Time frame: Basline and 6 months
Population: Baseline = 98~5 months = 87
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Testim + Viagra | Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit. | -11 units on a scale |
Secondary
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
Time frame: Baseline and 6 months
Population: Baseline = 5 5 months = 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Testim + Viagra | Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit. | 1 units on a scale |