Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems (PILUTS)
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547625
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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Purpose
Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Hyperplasia Prostate |
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 Multicenter, Parallel-Arm, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Tadalafil Administered Once Daily to Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- International Prostate Symptom Score (IPSS) sum total of questions 1-7 [ Time Frame: 6 and 12 weeks ]
Secondary Outcome Measures:
- Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII. [ Time Frame: 12 weeks ]
- Measure Uroflowmetry parameters [ Time Frame: 12 weeks ]
- Evaluate safety by PSA levels and postvoid residual volume (PVR) [ Time Frame: 12 weeks ]
| Enrollment: | 275 |
| Study Start Date: | October 2004 |
| Study Completion Date: | July 2005 |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.
|
Drug: placebo
Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.
|
|
Active Comparator: 2
Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.
|
Drug: tadalafil
Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.
Other Names:
|
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547625
Locations
| 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 | |
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
| ClinicalTrials.gov Identifier: | NCT00547625 History of Changes |
| Other Study ID Numbers: | 9120, H6D-MC-LVGC |
| Study First Received: | October 18, 2007 |
| Last Updated: | October 18, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia 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 21, 2013