Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431626
Status:
TERMINATED
Last Update Posted:
2015-10-28
First Post:
2007-02-02
Brief Title:
A Clinical Trial Comparing Laser TURP With and Without Dutasteride
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURPTransurethral Resection of the Prostate can provide effective and safe long term improvement of lower urinary tract symptoms
Detailed Description:
Benign Prostatic Hyperplasia BPH is the most common neoplastic condition afflicting middle-aged and elderly men BPH is a non-cancerous condition in which the prostate becomes enlarged which can cause lower urinary tract symptoms LUTS These symptoms include frequency urgency weak urinary stream difficulty starting or stopping to urinate and feeling the need to urinate even after just finishing urinating
One of the minimally invasive treatments for BPH is a Laser TURP The men going into this study would be planning on having a Holmium Laser TURP at Northwestern Memorial Hospital in Chicago Illinois
Another treatment for BPH is the use of a class of drugs called 5-Alpha Reductase Inhibitors 5ARI Dutasteride is a 5ARI that has been approved by the US Food and drug Administration FDA for the treatment of BPH
Each participant in this study will be randomized into ONE of the treatment groups below
1 Laser TURP combined with Dutasteride
2 Laser TURP combined with placebo
This study is double-masked which means neither the participant nor the study staff will know who is receiving active study drug or placebo There will be a 50 chance of receiving the study drug Dutasteride and a 50 chance of receiving a placebo
Dutasteride or its placebo comes as a 05mg capsule to be taken by mouth once a day at bedtime
There will be a screening period that may last up to 8 weeks It will include
There will be 2 or 3 screening visits to the clinic with each visit lasting approximately 25 to 3 hours
Each participant will be asked to complete various forms and questionnaires regarding their lower urinary tract symptoms and how they effect them and their sexual function
No study drug will be taken during this time
The Laser TURP at Northwestern Memorial Hospital will be scheduled
If each requirement has been met and it is determined that the participant is eligible to participate in this trial the participant will come to the clinic for a randomization visit
At this visit the participant will be randomized into one of the two treatment groups noted above Randomization is like a flip of a coin and neither the participant nor the study staff chooses which treatment will be given
Each participant will start taking the study drug everyday for six weeks before undergoing the Laser TURP and will continue taking the study drug every day for one year after the Laser TURP
If the Laser TURP requires having a catheter in place the participant will be seen by the urology clinic staff for follow up visits for this catheter This follow up schedule may require weekly visits
There will be follow up visits with the research staff The participant will be asked to come to the research clinic every three months for one year Each follow up visit will last approximately 15 hours
A final visit will take place at one year This will be identical to the first screening visit This visit will last approximately 2 hours
If the participant decides to withdraw from this study early he will be asked to come into the office for an early withdrawal visit
Please note The above detailed information regarding this research study is not in its entirety All of the above and more will be discussed in complete detail upon meeting with a research staff member or by calling the contact person mentioned in this protocol registration below
One of the minimally invasive treatments for BPH is a Laser TURP The men going into this study would be planning on having a Holmium Laser TURP at Northwestern Memorial Hospital in Chicago Illinois
Another treatment for BPH is the use of a class of drugs called 5-Alpha Reductase Inhibitors 5ARI Dutasteride is a 5ARI that has been approved by the US Food and drug Administration FDA for the treatment of BPH
Each participant in this study will be randomized into ONE of the treatment groups below
1 Laser TURP combined with Dutasteride
2 Laser TURP combined with placebo
This study is double-masked which means neither the participant nor the study staff will know who is receiving active study drug or placebo There will be a 50 chance of receiving the study drug Dutasteride and a 50 chance of receiving a placebo
Dutasteride or its placebo comes as a 05mg capsule to be taken by mouth once a day at bedtime
There will be a screening period that may last up to 8 weeks It will include
There will be 2 or 3 screening visits to the clinic with each visit lasting approximately 25 to 3 hours
Each participant will be asked to complete various forms and questionnaires regarding their lower urinary tract symptoms and how they effect them and their sexual function
No study drug will be taken during this time
The Laser TURP at Northwestern Memorial Hospital will be scheduled
If each requirement has been met and it is determined that the participant is eligible to participate in this trial the participant will come to the clinic for a randomization visit
At this visit the participant will be randomized into one of the two treatment groups noted above Randomization is like a flip of a coin and neither the participant nor the study staff chooses which treatment will be given
Each participant will start taking the study drug everyday for six weeks before undergoing the Laser TURP and will continue taking the study drug every day for one year after the Laser TURP
If the Laser TURP requires having a catheter in place the participant will be seen by the urology clinic staff for follow up visits for this catheter This follow up schedule may require weekly visits
There will be follow up visits with the research staff The participant will be asked to come to the research clinic every three months for one year Each follow up visit will last approximately 15 hours
A final visit will take place at one year This will be identical to the first screening visit This visit will last approximately 2 hours
If the participant decides to withdraw from this study early he will be asked to come into the office for an early withdrawal visit
Please note The above detailed information regarding this research study is not in its entirety All of the above and more will be discussed in complete detail upon meeting with a research staff member or by calling the contact person mentioned in this protocol registration below
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None