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Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

NCT00547625 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2007-10-22

No results posted yet for this study

Summary

Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.

Conditions

Interventions

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.

DRUG

placebo

Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Completion
2005-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00547625 on ClinicalTrials.gov