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NCT00827242 · ClinicalTrials.gov registry record · Phase 3

Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

A Phase 3 study of Benign Prostatic Hyperplasia, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
325
Enrollment target
20
Study locations

NCT00827242: Completed Phase 3 study of Benign Prostatic Hyperplasia, sponsored by Eli Lilly and Company.

NCT00827242 is a Phase 3 study of Benign Prostatic Hyperplasia that has completed, run by Eli Lilly and Company. The registered enrollment target is 325 participants, below the 541-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00827242, a Phase 3 study of Benign Prostatic Hyperplasia, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
325 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)

Primary Outcome

The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interactio

Conditions Studied

Benign Prostatic Hyperplasia

Interventions

  • DRUG Placebo
  • DRUG tadalafil

Study Locations (20)

Other

  • 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. - Buenos Aires
  • 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. - Berlin
  • 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. - Hamburg
  • 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. - Marburg
  • 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. - Mühlacker
  • 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. - Oranienburg
  • 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. - Bergamo
  • 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. - Milan

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. - Bay Shore
  • 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. - 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. - Williamsville

Alabama

  • 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. - Huntsville

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

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. - Sarasota

Georgia

  • 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. - Roswell

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

North Carolina

  • 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. - Durham

Trial Details

FieldValue
Enrollment Target 325 participants
Start Date 2009-01
Est. Completion 2009-11
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00827242 record still lists

NCT00827242 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 541-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (40% lower).

The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00827242 names 20 study sites across 11 states, led by Other, New York, Alabama.

Frequently Asked Questions

What is clinical trial NCT00827242 about?

NCT00827242 is a clinical study titled "Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily". The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)

What is the current status of trial NCT00827242?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2009-01. Estimated completion is 2009-11.

What conditions does trial NCT00827242 study?

This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.

What interventions are being tested in trial NCT00827242?

The interventions under investigation include: Placebo (DRUG), tadalafil (DRUG).

Who is sponsoring clinical trial NCT00827242?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00827242 being conducted?

This trial has 20 study locations across Alabama, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Benign Prostatic Hyperplasia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00827242's enrollment target sits among peer trials

325 6th of 29 higher than 24 of 29 other Benign Prostatic Hyperplasia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00827242, the US trial registry maintained by the National Library of Medicine. NCT00827242 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.