A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - LVHK

Eli Lilly and Company Limited0 sites190 target enrollmentOctober 18, 2007

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Effects on urodynamic parameters in men with benign prostatic hyperplasia (also referred to as BPH-LUTS [lower urinary tract symptoms]) with and without urodynamic evidence of bladder outlet obstruction. LUTS include urinary frequency, urgency, intermittency, nocturia, straining, incomplete emptying and weak urinary stream.
Sponsor: Eli Lilly and Company Limited
Enrollment: 190
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

October 18, 2007

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•\[1] Present with BPH LUTS based on the disease diagnostic criteria at Visit 1\.
•\[2] Are men 45 years of age or older at Visit 1\.
•\[3] Provide signed informed consent document at Visit 1\.
•\[4] Agree not to use any other approved or experimental pharmacologic treatments for BPH LUTS, including alpha blockers, 5\-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
•\[5] Have not taken the following treatments within the indicated duration:
•\[a] Finasteride or dutasteride therapy for at least 4 months prior to Visit 2\.
•\[b] All other LUTS therapy (including herbal preparations) for at least 4 weeks prior to Visit 2\.
•\[c] Any PDE5 inhibitor for at least 4 weeks prior to Visit 2\.
•\[6] Have LUTS with a total IPSS greater than or equal to 13 under 1 of the following conditions:
•\[a] At Visit 1 if the subject does not require wash out of therapy for BPH LUTS.

•\[1] PSA \>10\.0 ng/mL at Visit 1\.
•\[2] PSA of 4\.0 to 10\.0 ng/mL inclusive at Visit 1 without documentation of a histologic biopsy of the prostate negative for cancer within 12 months of Visit 1\.
•\[3] PVR measurement by ultrasound greater than or equal to 350 mL at Visit 1\.
•\[4] History of any of the following pelvic conditions:
•\[a] Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection.
•\[b] Pelvic radiotherapy.
•\[c] Any pelvic surgical procedure on the urinary tract.
•\[d] Lower urinary tract malignancy or trauma.
•\[e] Chronic pelvic pain syndrome.
•\[5] Lower urinary tract instrumentation within 30 days of Visit 1\.