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

Phase 3
Completed
Conditions
Impotence
Interventions
Registration Number
NCT00547287
Lead Sponsor
Eli Lilly and Company
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
2760
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
1sildenafilCurrently prescribed dosage of sildenafil is continued until wash-out period.
2tadalafil20 mg tadalafil given after one week sildenafil wash-out period.
Primary Outcome Measures
NameTimeMethod
Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase14 weeks
Secondary Outcome Measures
NameTimeMethod
Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.26 weeks

Trial Locations

Locations (1)

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.

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Sao Paulo, Brazil

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