HypogonadismPhase 4TRADENCT00194675
TRADE-Testosterone Replacement and Dutasteride Effectiveness
A Phase 4 study testing Dutasteride and Testosterone gel in people with Hypogonadism and Benign Prostatic Hyperplasia, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Benign Prostatic Hyperplasia
- What is being tested?
- Dutasteride and Testosterone gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Testosterone Replacement and Dutasteride Effectiveness (TRADE)
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
- Hypogonadism, Benign Prostatic Hyperplasia
- Being tested
- Dutasteride, Testosterone gel, Placebo dutasteride
- Keywords
- androgen deficiency, testosterone, Benign Prostatic Hyperplasia, hypogonadism, prostate, BPH
- Medical subject headings
- Hypogonadism, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Also called AndroGel
Dutasteride 0.5 mg orally daily
Testosterone gelDrug
Also called Testim
Testosterone gel 7.5 g daily topical
Placebo dutasterideDrug
placebo dutasteride orally daily
| Study group | Role | What they receive |
|---|---|---|
| Testosterone gel + oral placebo | Active comparator | Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily Receives: Drug: Testosterone gel; Drug: Placebo dutasteride |
| Testosterone gel + oral dutasteride | Active comparator | Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily Receives: Drug: Dutasteride; Drug: Testosterone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
Measured: Baseline, Month 6
Secondary outcomes (5)
Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
Measured: 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.
Measured: Baseline, Month 3, Month 6
Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)
Measured: Baseline, 3-months, 6-months
Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume
Measured: Baseline, 3-months, 6-months
Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.
Measured: Baseline, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Seattle Institute for Biomedical and Clinical Research, VA Office of Research and Development, Solvay Pharmaceuticals
- Responsible party
- Principal investigator, Alvin M. Matsumoto, MD, University of Washington
- Investigators
- Alvin M Matsumoto, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194675
- Sponsor's protocol ID
- 01166
- Other IDs
- 01166, 4-2280-V
- Acronym
- TRADE
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2005
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 12534854Yialamas 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 12787549Jin 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 11318778Behre 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 7514512Huggins 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 4625049Bhasin 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 12721204Morgentaler 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 8968017Schatzl 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 11304729Thompson 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 12824459Monti 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 11297606Page 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Replacement and Dutasteride Effectiveness (TRADE)
- ClinicalTrials.gov ID
- NCT00194675
- Acronym / sponsor ID
- TRADE / 01166
- Conditions
- Hypogonadism, Benign Prostatic Hyperplasia
- Keywords
- androgen deficiency, testosterone, Benign Prostatic Hyperplasia, hypogonadism, prostate, BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Seattle Institute for Biomedical and Clinical Research, VA Office of Research and Development, Solvay Pharmaceuticals
- Study start
- Mar 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 20 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone gel + oral placebo | Active comparator | Drug: Testosterone gel, Drug: Placebo dutasterideTestosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily |
| Testosterone gel + oral dutasteride | Active comparator | Drug: Dutasteride, Drug: Testosterone gelTestosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DutasterideAlso: AndroGelDutasteride 0.5 mg orally daily | Drug | Testosterone gel + oral dutasteride |
| Testosterone gelAlso: TestimTestosterone gel 7.5 g daily topical | Drug | Testosterone gel + oral dutasteride, Testosterone gel + oral placebo |
| Placebo dutasterideplacebo dutasteride orally daily | Drug | Testosterone gel + oral placebo |
Primary outcome
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
5 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)
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12534854Gruenewald 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.
- Background: PubMed 12787549Yialamas 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.
- Background: PubMed 11318778Jin 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.
- Background: PubMed 7514512Behre 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.
- Background: PubMed 4625049Huggins 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.
- Background: PubMed 12721204Bhasin 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.
- Background: PubMed 8968017Morgentaler A, Bruning CO 3rd, DeWolf WC. Occult prostate cancer in men with low serum testosterone levels. JAMA. 1996 Dec 18;276(23):1904-6.
- Background: PubMed 11304729Schatzl 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.
- Background: PubMed 12824459Thompson 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.
- Background: PubMed 11297606Monti 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.
- Results publication: PubMed 21575967Page 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.
Related trials for Hypogonadism
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingPhase 2
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
Hypogonadism, Prostate Cancer
Not yet recruitingPhase 2
HRT-PC Trial: Hormone Recovery After Treatment for Prostate Cancer Trial. An Open-label Phase II Study of Clomiphene Citrate in Patients With Persistent Hypogonadism After ADT for Treatment of Localized Prostate Cancer
Prostate Cancer
Active, not recruitingPhase 2
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic Obesity, Hypothalamic Tumor
Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Hypothalamic Obesity, Prader-Willi Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvin M Matsumoto, MD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dutasteride and Testosterone gel in people with Hypogonadism and Benign Prostatic Hyperplasia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00194675, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.