Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

Study Overview
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Brief Summary
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Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.

Official Title
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A Multicenter, Parallel-Arm, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Tadalafil Administered Once Daily to Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Conditions
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Prostatic Hyperplasia, Prostate

Intervention / Treatment
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* Drug: tadalafil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 month history of lower urinary tract symptoms either obstructive and/or irritative secondary to prostate related problems as diagnosed by a urologist. Stopped using treatments at least four weeks prior to study and agree to not use any other treatments during the study. Meet required prostate symptom score and urine flow rate. Exclusion Criteria: Serum prostate specific antigen (PSA) greater than 10 (between 4 and 10, inclusive, without a negative biopsy w/in the last 6 months. Prostate removal and various other pelvic surgeries. Neurological disease or condition known to affect the bladder. Clinical evidence of prostate cancer, urinary tract inflammation or infection, including prostatitis. Have taken medications such as nitrates, finasteride, or dutasteride within the year.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control. | Drug: placebo<br>* Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.<br>|
| Active Comparator: 2<br>Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks. | Drug: tadalafil<br>* Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.<br>* Other names: IC351;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) sum total of questions 1-7 |  | 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII. |  | 12 weeks | 
| Measure Uroflowmetry parameters |  | 12 weeks | 
| Evaluate safety by PSA levels and postvoid residual volume (PVR) |  | 12 weeks |