CompletedNCT00194675TRADEUpdated Dec 5, 2017Results posted

TRADE-Testosterone Replacement and Dutasteride Effectiveness

A Phase 4 interventional study of Dutasteride and Testosterone gel in Hypogonadism and Benign Prostatic Hyperplasia, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-05.

Sponsored by University of Washington · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 53
Allocation: Randomized
Ages: 50 Years and older
Sex: Male

Study summary

The purpose of this research study is to determine whether the combination of the male hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplasia [BPH]) compared to T treatment alone in men with low testosterone (called hypogonadism).

Read the detailed description

The primary aim of this study is to determine whether correction of hypogonadism using a combination of testosterone and dutasteride spares subjects from increases in prostate size and symptoms of BPH which may be associated with T alone.

We will also determine the effects of changes in serum T and dihydrotestosterone (DHT) on both the hormonal milieu and genetic program within the prostate gland itself. The technology employed will allow us to determine which genes are androgen responsive within each prostate tissue compartment. Together, these data may determine whether the combination of testosterone and dutasteride safely corrects the symptoms of BPH and hypogonadism and minimizes growth stimulus to the prostate at the genetic level. We will also assess the effects of the combination of T and dutasteride on cognitive function.

This is a six-month, double-blind, randomized, placebo-controlled, single-site study of older hypogonadal men with mild to moderate BPH.

Within each treatment group, a sub-group of subjects will undergo additional procedures as part of a Prostate Biopsy sub-study to obtain prostate tissue for hormonal and genetic analyses. Selection of subjects will be based on clinical indication and/or willingness to undergo prostate biopsies.

Conditions studied

Hypogonadism
Benign Prostatic Hyperplasia

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Keywords

androgen deficiency
testosterone
Benign Prostatic Hyperplasia
hypogonadism
prostate
BPH

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 53 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Generally healthy older men 50 years old or older
Hypogonadism; low testosterone (total T less than 280 ng/dL on one occasion or an average of equal to or less than 300 ng/dl on two occasions)
Prostate volume equal to or more than 30 cc by prostate MRI
Prostate Specific Antigen (PSA) equal to or more than 1.5 ng/mL and equal to or less than 10 ng/mL
Subjects with a PSA greater than 4.0 ng/ml must have a negative prostate biopsy
International Prostate Symptom Score (IPSS) greater than or equal to 8 and less than or equal to 20 at screening
Comply with study procedures for the full 10 months
No contraindications to MRI

Subjects with symptomatic Benign Prostatic Hyperplasia (BPH) will be recruited from the Urology and General Internal Medicine Clinics at the VA Puget Sound Health Care System and University of Washington Medical Center in Seattle.

Exclusion criteria

Exclusion Criteria:

A history of prostate or breast cancer
Invasive therapy for BPH in the past
History of acute urinary retention in the 3 months prior to screening
Previous treatment with a 5 alpha-reductase inhibitor (finasteride or dutasteride)
Medical therapy for BPH within the past month (alpha-blocker, phytotherapy)
Use of androgenic or antiandrogenic drugs in the past year
History or evidence of prostate cancer including suspicious DRE or history of high-grade PIN on prostate biopsy.
Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes)
Known untreated obstructive sleep apnea
Hematocrit greater than 52
Severe skin disease which may interfere with testosterone gel absorption
Hypersensitivity to any of the drugs used in the study
History of a bleeding disorder or need for chronic anticoagulation
Participation in a drug study concurrently or in the last 90 days
History or current evidence of drug or alcohol abuse within 12 mo.
Weight more than 300 lbs.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 53 participants (actual)

Study arms

Active comparator
Testosterone gel + oral placebo
Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily
Drug: Testosterone gel · Drug: Placebo dutasteride
Active comparator
Testosterone gel + oral dutasteride
Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily
Drug: Dutasteride · Drug: Testosterone gel

Interventions

DrugDutasteride
Dutasteride 0.5 mg orally daily
Also known as: AndroGel
DrugTestosterone gel
Testosterone gel 7.5 g daily topical
Also known as: Testim
DrugPlacebo dutasteride
placebo dutasteride orally daily

What researchers measure

Primary outcomes

Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
Time frame: Baseline, Month 6

Secondary outcomes

Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
Time frame: Baseline, Month 6
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)
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
Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Time frame: Baseline, 3-months, 6-months
Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
Time frame: Baseline, 3-months, 6-months
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Time frame: Baseline, 3-months, 6-months

Results

Posted Aug 20, 2012

Participant flow

Subjects were recruited from the VA Puget Sound Health Care System, Seattle, WA. 102 men were screened and 53 were randomized.

Participant flow — Overall Study
Milestone	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
Started	27	26
Completed	22	24
Not completed	5	2
Withdrew: Lost to follow-up	1	1
Withdrew: Lack of interest	1	1
Withdrew: Withdrew due to "edgy" feeling	1	0
Withdrew: Protocol violation	1	0
Withdrew: Death	1	0

Outcome measures

PrimaryEffects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.

Time frame:: Baseline, Month 6
Reported as:: Mean · cubic centimeters

Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
cubic centimeters	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
Baseline, Day 0	54.2 ± 38.1	44.4 ± 19.8
Month 6	58.3 ± 38.7	38.6 ± 18.4

SecondarySerum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)

Time frame:: Baseline, Month 6
Reported as:: Mean · ng/ ml

Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
ng/ ml	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
Baseline PSA	2.8 ± 2.9	2.1 ± 1.3
Month 6 PSA	3.1 ± 2.9	1.4 ± 1.2

SecondaryThe 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)

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
Reported as:: Mean · score

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)
score	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
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

SecondarySigns and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)

Time frame:: Baseline, 3-months, 6-months
Reported as:: Mean · cc/sec

Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
cc/sec	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
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

SecondarySigns and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume

Time frame:: Baseline, 3-months, 6-months
Reported as:: Mean · cc

Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
cc	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
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

SecondarySerum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.

Time frame:: Baseline, 3-months, 6-months
Reported as:: Mean · ng/ dL

Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
ng/ dL	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
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

Adverse events

Collected over 4 years. The study was conducted from March 2005 - March 2009.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Testosterone Gel + Oral Placebo	—	2/27 (7.4%)	7/27 (25.9%)
Testosterone Gel + Oral Dutasteride	—	0/26 (0%)	4/26 (15.4%)

Most frequent serious events

Most frequent serious events
Event	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
death from myocardial infarctionCardiac disorders	1/27	0/26
non-ST segment myocardial infarctionCardiac disorders	1/27	0/26

Most frequent other events

Most frequent other events
Event	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride
mild breast tendernessReproductive system and breast disorders	2/27	2/26
increase in prostate specific antigen (PSA)Reproductive system and breast disorders	2/27	0/26
Elevated hematocritBlood and lymphatic system disorders	2/27	0/26
ezcemaSkin and subcutaneous tissue disorders	0/27	1/26
exacerbation of pre-existing colitisGastrointestinal disorders	0/27	1/26
rashSkin and subcutaneous tissue disorders	1/27	0/26

Baseline characteristics

Age, Customized
Age, Customized(participants)	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride	Total
Between 50 and 82 years	63.5 ± 8.0	63.6 ± 5.5	63.55 ± 6.8

Sex: Female, Male
Sex: Female, Male(Participants)	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride	Total
Female	0	0	0
Male	27	26	53

Region of Enrollment
Region of Enrollment(participants)	Testosterone Gel + Oral Placebo	Testosterone Gel + Oral Dutasteride	Total
United States	27	26	53

Study locations

1 site

VA Puget Sound Health Care System
Seattle, Washington 98108, United States

References and documents

Publications

Gruenewald DA, Matsumoto AM. Testosterone supplementation therapy for older men: potential benefits and risks. J Am Geriatr Soc. 2003 Jan;51(1):101-15; discussion 115. doi: 10.1034/j.1601-5215.2002.51018.x. PubMed 12534854 ↗
Yialamas MA, Hayes FJ. Androgens and the ageing male and female. Best Pract Res Clin Endocrinol Metab. 2003 Jun;17(2):223-36. doi: 10.1016/s1521-690x(03)00018-6. PubMed 12787549 ↗
Jin B, Conway AJ, Handelsman DJ. Effects of androgen deficiency and replacement on prostate zonal volumes. Clin Endocrinol (Oxf). 2001 Apr;54(4):437-45. doi: 10.1046/j.1365-2265.2001.01240.x. PubMed 11318778 ↗
Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin Endocrinol (Oxf). 1994 Mar;40(3):341-9. doi: 10.1111/j.1365-2265.1994.tb03929.x. PubMed 7514512 ↗
Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available. PubMed 4625049 ↗
Bhasin S, Singh AB, Mac RP, Carter B, Lee MI, Cunningham GR. Managing the risks of prostate disease during testosterone replacement therapy in older men: recommendations for a standardized monitoring plan. J Androl. 2003 May-Jun;24(3):299-311. doi: 10.1002/j.1939-4640.2003.tb02676.x. No abstract available. PubMed 12721204 ↗
Morgentaler A, Bruning CO 3rd, DeWolf WC. Occult prostate cancer in men with low serum testosterone levels. JAMA. 1996 Dec 18;276(23):1904-6. PubMed 8968017 ↗
Schatzl G, Madersbacher S, Thurridl T, Waldmuller J, Kramer G, Haitel A, Marberger M. High-grade prostate cancer is associated with low serum testosterone levels. Prostate. 2001 Apr;47(1):52-8. doi: 10.1002/pros.1046. PubMed 11304729 ↗
Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. doi: 10.1056/NEJMoa030660. Epub 2003 Jun 24. PubMed 12824459 ↗
Monti S, Di Silverio F, Iraci R, Martini C, Lanzara S, Falasca P, Poggi M, Stigliano A, Sciarra F, Toscano V. Regional variations of insulin-like growth factor I (IGF-I), IGF-II, and receptor type I in benign prostatic hyperplasia tissue and their correlation with intraprostatic androgens. J Clin Endocrinol Metab. 2001 Apr;86(4):1700-6. doi: 10.1210/jcem.86.4.7413. PubMed 11297606 ↗
Page ST, Hirano L, Gilchriest J, Dighe M, Amory JK, Marck BT, Matsumoto AM. Dutasteride reduces prostate size and prostate specific antigen in older hypogonadal men with benign prostatic hyperplasia undergoing testosterone replacement therapy. J Urol. 2011 Jul;186(1):191-7. doi: 10.1016/j.juro.2011.03.026. Epub 2011 May 14. PubMed 21575967 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00194675
Lead sponsor: University of Washington
Collaborators: GlaxoSmithKline, Seattle Institute for Biomedical and Clinical Research, VA Office of Research and Development, Solvay Pharmaceuticals
Responsible party: Alvin M. Matsumoto, MD (Professor, University of Washington) — Principal investigator
First posted: Sep 19, 2005
Start date: Mar 2005
Primary completion: Apr 2010
Completion: Dec 2010
Results posted: Aug 20, 2012
Last update: Dec 5, 2017

Study contacts

Alvin M Matsumoto, MD

principal investigator · VA Puget Sound Health Care System

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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