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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547625

Acronym

PILUTS

Enrollment

275

Registered

2007-10-22

Start date

2004-10-31

Completion date

2005-07-31

Last updated

2007-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate, Prostatic Hyperplasia

Brief summary

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

Interventions

DRUGtadalafil

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.

DRUGplacebo

Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Evaluate safety by PSA levels and postvoid residual volume (PVR)	12 weeks
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026