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

NCT00540124 | Completed Phase 2 Results

• 2 other identifiers: 11658H6D-MC-LVHT
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

  The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

  baseline, 12 weeks

Secondary Outcomes (12)

• Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score

  baseline, 4 and 8 weeks

• Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore

  baseline, 4, 8, and 12 weeks

• Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore

  baseline, 4, 8, and 12 weeks

• Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore

  baseline, 4, 8, and 12 weeks

• Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)

  baseline, 12 weeks

Study Arms (3)

Tadalafil

EXPERIMENTAL

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Tamsulosin

ACTIVE COMPARATOR

Drug: Tamsulosin

Interventions

Tadalafil DRUG

5 mg once a day

Also known as: LY450190, Cialis

Tadalafil

Placebo DRUG

once a day

Placebo

Tamsulosin DRUG

0.2 mg once a day

Tamsulosin

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.

You may not qualify if:

• Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

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.

Jeonju, 561-712, South Korea

Location

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.

Kwangju, 501-757, South Korea

Location

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, South Korea

Location

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, South Korea

Location

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, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 5, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 25, 2010
• Results First Posted: July 20, 2009

Record last verified: 2010-11

Locations

KR (5)