A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

November 6, 2007 updated by: Eli Lilly and Company

A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Bothell, Washington, United States
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men with erectile dysfunction
  • At least 18 years of age

Exclusion Criteria:

  • Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
  • A history of certain impotence disorders
  • History of specified pelvic surgery
  • Any significant genital abnormality identified at the start of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
placebo tablet
Drug: placebo
Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.
Active Comparator: 2
2.5 mg tadalafil tablet
Drug: tadalafil
2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 3
5 mg tadalafil tablet
Drug: tadalafil
2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
Other Names:
  • LY450190
  • Cialis
  • IC351

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.
Time Frame: 24-128 weeks
24-128 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

ICOS Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 27, 2006

First Posted (Estimate)

September 28, 2006

Study Record Updates

Last Update Posted (Estimate)

November 7, 2007

Last Update Submitted That Met QC Criteria

November 6, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7019
  • H6D-MC-LVFP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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