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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547287
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
ICOS Corporation
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Impotence Drug: tadalafil Drug: sildenafil Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2760 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference
Study Start Date : November 2002
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase [ Time Frame: 14 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547287

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.
Sao Paulo, Brazil
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Study Director: 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

Additional Information: Identifier: NCT00547287     History of Changes
Other Study ID Numbers: 7925
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents