A Clinical Trial Comparing Laser TURP With and Without Dutasteride. (NCT00431626) | Clinical Trial Compass
TerminatedPhase 3
A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
Stopped: Low enrollment
4 participantsStarted 2006-10
Plain-language summary
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.
Who can participate
Age range50 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient is a male at least 50 years of age.
* The patient's peak urinary flow rate is at least 4 ml/sec, but not greater than 15 ml/sec, and the voided volume is at least 125 ml.
* Prostate volume must be greater than 30 grams
* The AUA-SI is greater than or equal to 9.
* Patient must be scheduled for a Laser TURP or eligible to be scheduled for Laser TURP
* Patient must be able to complete the study requirements prior to the scheduled laser TURP.
* The patient has signed the informed consent prior to the performance of any study procedures.
Exclusion Criteria:
* The patient has had any prior surgical intervention for BPH.
* The patient is receiving any intervention for prostate disease (either medical or surgical) or is presently enrolled in any study protocol.
* The patient has had a previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to dutasteride.
* The patient has taken an alpha-1 blocker within 1 month of randomization.
* The patient has taken finasteride or dutasteride within 3 months of randomization.
* The patient has taken phenylephrine, pseudoephedrine, imipramine, and an anticholinergic or cholinergic medication within 4 weeks of the screening visit.
* The patient has taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids.
* The patient has an inability to urinate.
* The patient has clinically significant renal or hepatic impairment (i.e., creatinine greater than 2.0 mg…
What they're measuring
1
Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index