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

Lilly

Status and phase: Completed; Phase 2

Conditions: Prostate; Prostatic Hyperplasia

Treatments: Drug: placebo; Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547625

H6D-MC-LVGC

9120

Details and patient eligibility

About

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

Enrollment: 275 patients

Sex: Male

Ages: 45+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

275 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.

Treatment:

Drug: placebo

2

Active Comparator group

Description:

Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.

Treatment:

Drug: tadalafil