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Clinical Trials/NCT00547287
NCT00547287CompletedPhase 3

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

Eli Lilly and Company1 site in 1 country2,760 target enrollmentStarted: November 2002Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
2,760
Locations
1
Primary Endpoint
Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

1

Active Comparator

Currently prescribed dosage of sildenafil is continued until wash-out period.

Intervention: sildenafil (Drug)

2

Active Comparator

20 mg tadalafil given after one week sildenafil wash-out period.

Intervention: tadalafil (Drug)

Outcomes

Primary Outcomes

Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase

Time Frame: 14 weeks

Secondary Outcomes

  • Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.(26 weeks)

Investigators

Sponsor Class
Industry

Study Sites (1)

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