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

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

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 year

AUA 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

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

Borko D. Jovanovic, MS, PhD

Northwestern U

Phone: 312 503 2008

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place