Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

NCT00836693 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2011-01-04

Study results available
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Summary

The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Conditions

Interventions

DRUG

tadalafil

5 milligrams (mg) administered orally once a day for 12 weeks

DRUG

placebo

tablet administered orally once a day for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY(1-877-285-459) 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
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Germany
  • Greece
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

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 NCT00836693 on ClinicalTrials.gov