Trial Outcomes & Findings for A Clinical Trial Comparing Laser TURP With and Without Dutasteride. (NCT NCT00431626)
NCT ID: NCT00431626
Last Updated: 2015-10-28
Results Overview
AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
one year
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
Treatment
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
Baseline characteristics by cohort
| Measure |
Laser TURP With Dutasteride
n=4 Participants
Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
Dutasteride (Avodart)
|
Laser TURP With Placebo
Prior to and after standard treatment with laser TURP, placebo is applied to each patient
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 12 • n=5 Participants
|
—
|
47 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Male
|
4 participants
n=5 Participants
|
—
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearAUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
Outcome measures
| Measure |
Laser TURP With Dutasteride
n=4 Participants
Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient
Dutasteride (Avodart)
|
Laser TURP With Placebo
Prior to and after standard treatment with laser TURP, placebo is applied to each patient
|
|---|---|---|
|
Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
|
1 units on a scale
Standard Deviation 0.8
|
—
|
Adverse Events
Laser TURP With Dutasteride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laser TURP With Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place