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Trial record 39 of 117 for:    DUTASTERIDE

TRADE-Testosterone Replacement and Dutasteride Effectiveness (TRADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00194675
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : August 20, 2012
Last Update Posted : December 5, 2017
Sponsor:
Collaborators:
GlaxoSmithKline
Seattle Institute for Biomedical and Clinical Research
VA Office of Research and Development
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Alvin M. Matsumoto, MD, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hypogonadism
Benign Prostatic Hyperplasia
Interventions Drug: Dutasteride
Drug: Testosterone gel
Drug: Placebo dutasteride
Enrollment 53
Recruitment Details Subjects were recruited from the VA Puget Sound Health Care System, Seattle, WA. 102 men were screened and 53 were randomized.
Pre-assignment Details 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.
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
Period Title: Overall Study
Started 27 26
Completed 22 24
Not Completed 5 2
Reason Not Completed
Lost to Follow-up             1             1
lack of interest             1             1
withdrew due to "edgy" feeling             1             0
Protocol Violation             1             0
Death             1             0
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride Total
Hide Arm/Group Description Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months Total of all reporting groups
Overall Number of Baseline Participants 27 26 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Standard Deviation)
Unit of measure:  Participants
Between 50 and 82 years Number Analyzed 27 participants 26 participants 53 participants
63.5  (8.0) 63.6  (5.5) 63.55  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
27
 100.0%
26
 100.0%
53
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 26 participants 53 participants
27 26 53
1.Primary Outcome
Title Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
Hide Description [Not Specified]
Time Frame Baseline, Month 6
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Hide Analysis Population Description
per protocol
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description:
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: cubic centimeters
Baseline, Day 0 54.2  (38.1) 44.4  (19.8)
Month 6 58.3  (38.7) 38.6  (18.4)
2.Secondary Outcome
Title Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
Hide Description [Not Specified]
Time Frame Baseline, Month 6
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per protocol
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description:
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: ng/ ml
Baseline PSA 2.8  (2.9) 2.1  (1.3)
Month 6 PSA 3.1  (2.9) 1.4  (1.2)
3.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline, Month 3, Month 6
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per protocol
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description:
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score
Baseline IPSS 13.5  (2.7) 13.3  (3.1)
Month 3- IPSS 11.6  (5.0) 10.2  (5.4)
Month 6 IPSS 11.1  (5.2) 10.3  (6.6)
4.Secondary Outcome
Title Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Hide Description [Not Specified]
Time Frame Baseline, 3-months, 6-months
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per protocol
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description:
Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: cc/sec
Baseline Uroflow, Baseline 13.8  (3.0) 13.4  (3.5)
Uroflow after 3 months of treatment 12.7  (3.4) 13.2  (5.8)
Uroflow after 6 months of treatment 13.8  (5.1) 14.6  (6.7)
5.Secondary Outcome
Title Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
Hide Description [Not Specified]
Time Frame Baseline, 3-months, 6-months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description:
Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: cc
Baseline Post Residual Volume (PVR) 43  (44) 48  (55)
3 month Post Residual Volume 36  (36) 41  (42)
6 month Post Residual Volume 39  (45) 32  (36)
6.Secondary Outcome
Title Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Hide Description [Not Specified]
Time Frame Baseline, 3-months, 6-months
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Hide Analysis Population Description
per protocol
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description:
Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: ng/ dL
Total testosterone, baseline 206  (109) 213  (68)
Total testosterone, month 3 494  (331) 525  (268)
Total testosterone, month 6 481  (329) 534  (360)
Free testosterone, baseline 4.2  (2.0) 4.5  (1.8)
Free testosterone, month 3 11.3  (6.8) 12.0  (6.1)
Free testosterone, month 6 11.4  (11.1) 12.3  (9.6)
Dihydrotestosterone (DHT), baseline 47  (94) 28  (15)
Dihydrotestosterone (DHT), month 3 145  (120) 16  (11)
Dihydrotestosterone (DHT), month 6 134  (87) 12  (7)
Dehydroepiandrosterone (DHEA), baseline 72  (42) 99  (68)
Dehydroepiandrosterone (DHEA), month 3 98  (92) 109  (93)
Dehydroepiandrosterone (DHEA), month 6 97  (86) 111  (90)
Androstenedione, baseline 45  (21) 47  (28)
Androstenedione, month 3 99  (72) 140  (60)
Androstenedione, month 6 100  (57) 123  (61)
Time Frame 4 years. The study was conducted from March 2005 - March 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Hide Arm/Group Description Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
All-Cause Mortality
Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/27 (7.41%)      0/26 (0.00%)    
Cardiac disorders     
death from myocardial infarction  [1]  1/27 (3.70%)  1 0/26 (0.00%)  0
non-ST segment myocardial infarction  [2]  1/27 (3.70%)  1 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject had history of cardiovascular disease prior to randomization and normal hematocrit. Subject died during month 6.
[2]
Subject had history of cardiovascular disease prior to randomization and normal hematocrit. Adverse event occurred during month 4.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Testosterone Gel + Oral Placebo Testosterone Gel + Oral Dutasteride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/27 (25.93%)      4/26 (15.38%)    
Blood and lymphatic system disorders     
Elevated hematocrit   2/27 (7.41%)  2 0/26 (0.00%)  0
Gastrointestinal disorders     
exacerbation of pre-existing colitis   0/27 (0.00%)  0 1/26 (3.85%)  1
Reproductive system and breast disorders     
mild breast tenderness   2/27 (7.41%)  2 2/26 (7.69%)  2
increase in prostate specific antigen (PSA)   2/27 (7.41%)  2 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
ezcema *  0/27 (0.00%)  0 1/26 (3.85%)  1
rash  [1]  1/27 (3.70%)  1 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
transient rash at gel application site
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alvin M. Matsumoto, MD
Organization: VA Puget Sound Health Care System
Phone: (206) 764-2760
EMail: alvin.matsumoto@med.va.gov
Other Publications:
Layout table for additonal information
Responsible Party: Alvin M. Matsumoto, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00194675     History of Changes
Other Study ID Numbers: 01166
01166, 4-2280-V ( Other Identifier: VA Puget Sound Health Care System Human Subject Division )
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: May 2, 2012
Results First Posted: August 20, 2012
Last Update Posted: December 5, 2017