Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

October 18, 2007 updated by: Eli Lilly and Company

Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference

Study to determine if men from around the world prefer sildenafil to tadalafil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2760

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

  • Brazil
      • Sao Paulo, Brazil
        • 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:

  • Must be of legal age according to your country.
  • Must have had a history of erectile dysfunction for at least 3 months.
  • Must currently and have been using sildenafil for the last six weeks.
  • Agree to not use any other ED treatment during the study.
  • Anticipate the same female sexual partner for the study.

Exclusion Criteria:

  • History of other primary sexual disorder
  • Treatment with nitrates
  • Have a penile implant or clinically significant penile deformity
  • History of certain heart problems
  • Do not meet certain lab value reference ranges

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
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Currently prescribed dosage of sildenafil is continued until wash-out period.
Drug: sildenafil
Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.
Active Comparator: 2
20 mg tadalafil given after one week sildenafil wash-out period.
Drug: tadalafil
20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.
Other Names:
  • LY450190
  • Cialis
  • IC351

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.
Time Frame: 26 weeks
26 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

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

November 1, 2002

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

October 22, 2007

Last Update Submitted That Met QC Criteria

October 18, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7925
  • H6D-VI-LVFH

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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