Prostatic HyperplasiaPhase 4NCT00062790
Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels
A Phase 4 study testing Dutasteride in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 11 sites in United States.
Trial summary
This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Dutasteride
- How many people
- 50 participants
- Where
- 11 sitesUnited States
- Study dates
- Oct 2003to Jul 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with benign prostatic hyperplasia
- Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
- PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml.
Who cannot join
- Prostate cancer.
- Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
- Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
- History of chronic UTIs (urinary tract infections)
- Presence of acute bacterial prostatitis at screening
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Boston, Massachusetts, 02114-3139
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Eugene, Oregon, 97401-8122
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
New Britain, Connecticut, 06052
GSK Investigational Site
Niles, Illinois, 60714
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Trumbull, Connecticut, 06611
About this study
Official title: Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels
This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Dutasteride
- Keywords
- Testosterone, DHT, TURP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).
Secondary outcomes (2)
Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
Changes in serum DHT (dihydrotestosterone) and T (testosterone).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2003 (estimated)
- Study startOct 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062790
- Sponsor's protocol ID
- ARI40014
- Status last verified
- Sep 2016
- First submitted
- 16 Jun 2003
- Last updated
- 15 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels
- ClinicalTrials.gov ID
- NCT00062790
- Acronym / sponsor ID
- ARI40014
- Conditions
- Prostatic Hyperplasia
- Keywords
- Testosterone, DHT, TURP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Jul 2005 (actual)
- First posted
- 17 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with benign prostatic hyperplasia
- Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
- PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml.
Key exclusion criteria (5 listed)
- Prostate cancer.
- Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
- Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
- History of chronic UTIs (urinary tract infections)
- Presence of acute bacterial prostatitis at screening
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 |
|---|---|---|
| Dutasteride | Drug | – |
Primary outcome
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).
2 secondary outcomes
Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
Changes in serum DHT (dihydrotestosterone) and T (testosterone).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites 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 in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 11 sites 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 3 inclusion and 5 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2016.