Trial Outcomes & Findings for TRADE-Testosterone Replacement and Dutasteride Effectiveness (NCT NCT00194675)
NCT ID: NCT00194675
Last Updated: 2017-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2017-12-05
Participant Flow
Subjects were recruited from the VA Puget Sound Health Care System, Seattle, WA. 102 men were screened and 53 were randomized.
49 were excluded. 4 withdrew consent, 3 lost to follow-up, 42 for inclusion/exclusion criteria: 3 could not tolerate MRI, 3 were previously on testosterone therapy, 21 had prostate volume \<30cc, 12 had repeat serum testosterone \>280 ng/mL, and 3 had prostate cancer or prostate intraepithelial neoplasia at pre-treatment prostate biopsy.
Participant milestones
| Measure |
Testosterone Gel + Oral Placebo
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Testosterone Gel + Oral Placebo
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
lack of interest
|
1
|
1
|
|
Overall Study
withdrew due to "edgy" feeling
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
TRADE-Testosterone Replacement and Dutasteride Effectiveness
Baseline characteristics by cohort
| Measure |
Testosterone Gel + Oral Placebo
n=27 Participants
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 Participants
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 50 and 82 years
|
63.5 participants
STANDARD_DEVIATION 8.0 • n=5 Participants
|
63.6 participants
STANDARD_DEVIATION 5.5 • n=7 Participants
|
63.55 participants
STANDARD_DEVIATION 6.8 • 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
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: per protocol
Outcome measures
| Measure |
Testosterone Gel + Oral Placebo
n=27 Participants
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 Participants
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
Baseline, Day 0
|
54.2 cubic centimeters
Standard Deviation 38.1
|
44.4 cubic centimeters
Standard Deviation 19.8
|
|
Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
Month 6
|
58.3 cubic centimeters
Standard Deviation 38.7
|
38.6 cubic centimeters
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: per protocol
Outcome measures
| Measure |
Testosterone Gel + Oral Placebo
n=27 Participants
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 Participants
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
Baseline PSA
|
2.8 ng/ ml
Standard Deviation 2.9
|
2.1 ng/ ml
Standard Deviation 1.3
|
|
Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
Month 6 PSA
|
3.1 ng/ ml
Standard Deviation 2.9
|
1.4 ng/ ml
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: per protocol
International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales.
Outcome measures
| Measure |
Testosterone Gel + Oral Placebo
n=27 Participants
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 Participants
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)
Baseline IPSS
|
13.5 score
Standard Deviation 2.7
|
13.3 score
Standard Deviation 3.1
|
|
The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)
Month 3- IPSS
|
11.6 score
Standard Deviation 5.0
|
10.2 score
Standard Deviation 5.4
|
|
The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)
Month 6 IPSS
|
11.1 score
Standard Deviation 5.2
|
10.3 score
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline, 3-months, 6-monthsPopulation: per protocol
Outcome measures
| Measure |
Testosterone Gel + Oral Placebo
n=27 Participants
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 Participants
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Baseline Uroflow, Baseline
|
13.8 cc/sec
Standard Deviation 3.0
|
13.4 cc/sec
Standard Deviation 3.5
|
|
Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Uroflow after 3 months of treatment
|
12.7 cc/sec
Standard Deviation 3.4
|
13.2 cc/sec
Standard Deviation 5.8
|
|
Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Uroflow after 6 months of treatment
|
13.8 cc/sec
Standard Deviation 5.1
|
14.6 cc/sec
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline, 3-months, 6-monthsOutcome measures
| Measure |
Testosterone Gel + Oral Placebo
n=27 Participants
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 Participants
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
Baseline Post Residual Volume (PVR)
|
43 cc
Standard Deviation 44
|
48 cc
Standard Deviation 55
|
|
Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
3 month Post Residual Volume
|
36 cc
Standard Deviation 36
|
41 cc
Standard Deviation 42
|
|
Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
6 month Post Residual Volume
|
39 cc
Standard Deviation 45
|
32 cc
Standard Deviation 36
|
SECONDARY outcome
Timeframe: Baseline, 3-months, 6-monthsPopulation: per protocol
Outcome measures
| Measure |
Testosterone Gel + Oral Placebo
n=27 Participants
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 Participants
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Androstenedione, month 6
|
100 ng/ dL
Standard Deviation 57
|
123 ng/ dL
Standard Deviation 61
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Total testosterone, baseline
|
206 ng/ dL
Standard Deviation 109
|
213 ng/ dL
Standard Deviation 68
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Total testosterone, month 3
|
494 ng/ dL
Standard Deviation 331
|
525 ng/ dL
Standard Deviation 268
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Total testosterone, month 6
|
481 ng/ dL
Standard Deviation 329
|
534 ng/ dL
Standard Deviation 360
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Free testosterone, baseline
|
4.2 ng/ dL
Standard Deviation 2.0
|
4.5 ng/ dL
Standard Deviation 1.8
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Free testosterone, month 3
|
11.3 ng/ dL
Standard Deviation 6.8
|
12.0 ng/ dL
Standard Deviation 6.1
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Free testosterone, month 6
|
11.4 ng/ dL
Standard Deviation 11.1
|
12.3 ng/ dL
Standard Deviation 9.6
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Dihydrotestosterone (DHT), baseline
|
47 ng/ dL
Standard Deviation 94
|
28 ng/ dL
Standard Deviation 15
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Dihydrotestosterone (DHT), month 3
|
145 ng/ dL
Standard Deviation 120
|
16 ng/ dL
Standard Deviation 11
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Dihydrotestosterone (DHT), month 6
|
134 ng/ dL
Standard Deviation 87
|
12 ng/ dL
Standard Deviation 7
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Dehydroepiandrosterone (DHEA), baseline
|
72 ng/ dL
Standard Deviation 42
|
99 ng/ dL
Standard Deviation 68
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Dehydroepiandrosterone (DHEA), month 3
|
98 ng/ dL
Standard Deviation 92
|
109 ng/ dL
Standard Deviation 93
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Dehydroepiandrosterone (DHEA), month 6
|
97 ng/ dL
Standard Deviation 86
|
111 ng/ dL
Standard Deviation 90
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Androstenedione, baseline
|
45 ng/ dL
Standard Deviation 21
|
47 ng/ dL
Standard Deviation 28
|
|
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Androstenedione, month 3
|
99 ng/ dL
Standard Deviation 72
|
140 ng/ dL
Standard Deviation 60
|
Adverse Events
Testosterone Gel + Oral Placebo
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Testosterone Gel + Oral Dutasteride
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone Gel + Oral Placebo
n=27 participants at risk
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 participants at risk
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Cardiac disorders
death from myocardial infarction
|
3.7%
1/27 • Number of events 1 • 4 years. The study was conducted from March 2005 - March 2009.
|
0.00%
0/26 • 4 years. The study was conducted from March 2005 - March 2009.
|
|
Cardiac disorders
non-ST segment myocardial infarction
|
3.7%
1/27 • Number of events 1 • 4 years. The study was conducted from March 2005 - March 2009.
|
0.00%
0/26 • 4 years. The study was conducted from March 2005 - March 2009.
|
Other adverse events
| Measure |
Testosterone Gel + Oral Placebo
n=27 participants at risk
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
|
Testosterone Gel + Oral Dutasteride
n=26 participants at risk
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
|
|---|---|---|
|
Reproductive system and breast disorders
mild breast tenderness
|
7.4%
2/27 • Number of events 2 • 4 years. The study was conducted from March 2005 - March 2009.
|
7.7%
2/26 • Number of events 2 • 4 years. The study was conducted from March 2005 - March 2009.
|
|
Skin and subcutaneous tissue disorders
ezcema
|
0.00%
0/27 • 4 years. The study was conducted from March 2005 - March 2009.
|
3.8%
1/26 • Number of events 1 • 4 years. The study was conducted from March 2005 - March 2009.
|
|
Gastrointestinal disorders
exacerbation of pre-existing colitis
|
0.00%
0/27 • 4 years. The study was conducted from March 2005 - March 2009.
|
3.8%
1/26 • Number of events 1 • 4 years. The study was conducted from March 2005 - March 2009.
|
|
Reproductive system and breast disorders
increase in prostate specific antigen (PSA)
|
7.4%
2/27 • Number of events 2 • 4 years. The study was conducted from March 2005 - March 2009.
|
0.00%
0/26 • 4 years. The study was conducted from March 2005 - March 2009.
|
|
Blood and lymphatic system disorders
Elevated hematocrit
|
7.4%
2/27 • Number of events 2 • 4 years. The study was conducted from March 2005 - March 2009.
|
0.00%
0/26 • 4 years. The study was conducted from March 2005 - March 2009.
|
|
Skin and subcutaneous tissue disorders
rash
|
3.7%
1/27 • Number of events 1 • 4 years. The study was conducted from March 2005 - March 2009.
|
0.00%
0/26 • 4 years. The study was conducted from March 2005 - March 2009.
|
Additional Information
Alvin M. Matsumoto, MD
VA Puget Sound Health Care System
Phone: (206) 764-2760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place