Clinical trial NCT00431626 (phase 3, status: terminated)
Conditions: benign prostatic hyperplasia
ICD codes: N40.0, N40.1
Drugs: dutasteride (avodart), placebo
SMILES: [H][C@@]1(CC[C@@]2([H])[C@]3([H])CC[C@@]4([H])NC(=O)C=C[C@]4(C)[C@@]3([H])CC[C@]12C)C(=O)NC1=CC(=CC=C1C(F)(F)F)C(F)(F)F, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    low enrollment
  
Eligibility criteria:

        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/dl or AST greater than 1.5 times the upper limit of normal).

          -  The patient has a PSA level greater than 10 ug/ml (Hybritech).

          -  The patient requires the daily use of a pad or device for incontinence.

          -  The patient has had an episode of unstable angina pectoris, a myocardial infarction,
             transient ischemic attack, or a cerebrovascular accident within the past six months.

          -  The patient has a penile prosthesis or artificial urinary sphincter.

          -  The patient has a history or current evidence of carcinoma of the prostate or bladder,
             pelvic radiation or surgery, urethral stricture, prior surgery for BPH, or bladder
             neck obstruction.

          -  The patient has an active urinary tract disease or has undergone cystoscopy or biopsy
             of the prostate within two weeks prior to the first screening visit.

          -  The patient has known primary neurologic conditions such as multiple sclerosis or
             Parkinson's disease or other neurological diseases known to affect bladder function.

          -  The patient has had documented bacterial prostatitis within the past year.

          -  The patient has had two documented urinary tract infections of any type in the past
             year. A urinary tract infection is defined as >100,000 colonies per ml urine from
             midstream clean catch or catheterized specimen.

          -  The patient has a severe bleeding disorder that makes laser TURP impossible.

          -  The patient must be able to stop any anticoagulant, NSAID or anti-platelet for 7 days
             prior to the laser TURP.

          -  The patient has had cancer that is not considered cured (except basal cell or squamous
             cell carcinoma of the skin). A patient is considered cured if there has been no
             evidence of cancer within five years of randomization.

          -  The patient has a diagnosis of a thought disorder (i.e., schizophrenia, bipolar
             disorder)

          -  The patient has any serious medical condition likely to impede successful completion
             of the study.

          -  The patient has a defibrillator that cannot be deactivated during laser TURP
             treatment.

          -  A bladder neck to verumontanum distance which is less than 30mm in length as measured
             by flexible cystoscopy and a total prostate volume <25 ml or >110 ml as measured by
             prostate volume ellipsoid formula during TRUS.