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A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

NCT00734604 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2010-11-18

Study results available
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Summary

The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

Conditions

Interventions

DRUG

tadalafil once a day [T(OaD)]

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

DRUG

sildenafil citrate as needed [S(PRN)]

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

DRUG

tadalafil as needed [T(PRN)]

20 mg tablet taken as needed (PRN) by mouth for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Australia
  • Brazil
  • Germany
  • Italy
  • Mexico
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00734604 on ClinicalTrials.gov