Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00386009
First received: October 9, 2006
Last updated: July 1, 2009
Last verified: July 2009
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Purpose
The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Prostatic Hyperplasia |
Drug: Tadalafil Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Urine and Urination
Drug Information available for:
Tadalafil
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Presence of Involuntary Detrusor Contractions During Bladder Filling [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 200 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
|
|
Active Comparator: 2
tadalafil
|
Drug: Tadalafil
20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
Other Names:
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
- Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
- Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
- Have had BPH-LUTS for greater than 6 months prior to Visit 1.
Exclusion Criteria:
- Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
- History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
- Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
- History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
- History of angina requiring treatment with nitrates.
- Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386009
Locations
| United States, California | |
| 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. | |
| Newport Beach, California, United States, 92660 | |
| 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. | |
| Tarzana, California, United States, 91356 | |
| United States, Connecticut | |
| 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. | |
| Middlebury, Connecticut, United States, 06762 | |
| United States, Florida | |
| 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. | |
| Orlando, Florida, United States, 32803 | |
| United States, Illinois | |
| 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. | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| 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. | |
| Fort Wayne, Indiana, United States, 46825 | |
| United States, New York | |
| 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. | |
| Garden City, New York, United States, 11530 | |
| United States, Texas | |
| 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. | |
| San Antonio, Texas, United States, 78229 | |
| Greece | |
| 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. | |
| Patras, Greece, 26500 | |
| 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. | |
| Thessaloniki, Greece, 56429 | |
| Portugal | |
| 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. | |
| Coimbra, Portugal, 3000-076 | |
| 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. | |
| Lisbon, Portugal, 1549-008 | |
| 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. | |
| Porto, Portugal, 4200-319 | |
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
| Study Director: | 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00386009 History of Changes |
| Other Study ID Numbers: | 11233, H6D-MC-LVHK |
| Study First Received: | October 9, 2006 |
| Results First Received: | May 4, 2009 |
| Last Updated: | July 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Signs and Symptoms Prostatic Diseases Genital Diseases, Male Pathologic Processes Tadalafil Phosphodiesterase 5 Inhibitors |
Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013