Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia in Asian Men

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: Tadalafil (Drug); Placebo (Drug); Tamsulosin (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: IPSS total score

Secondary outcome:

IPSS total score

IPSS subscores

BPH-II, Patient Diary, Uroflowmetry parameters, and symptom improvement scales

Safety

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at

least 6 months prior to Visit 1.

- Agree not to use any other approved or experimental treatments for erectile

dysfunction or BPH-LUTS during the study.

- Have not taken Finasteride therapy for at least 3 months prior to Visit 2.

- Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.

- Have an IPSS total score greater than or equal to 13 at Visit 2.

Exclusion Criteria:

- Prostate Specific Antigen (PSA) greater than 10. 0 ng/mL at Visit 1.

- Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at

Visit 1.

- History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower

urinary tract malignancy or trauma.

- Urinary tract infection or inflammation or current antibiotic therapy for urinary

tract infection at Visit 1.

- Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jeon Ju-City 561-712, Korea, Republic of

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kwang Ju 501-757, Korea, Republic of

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pusan 614-735, Korea, Republic of

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seoul 140-757, Korea, Republic of

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kyunggi-Do 425-020, Korea, Republic of

Lilly Clinical Trial Registry

Starting date: October 2007
Ending date: July 2008
Last updated: April 14, 2008