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

Phase 3CompletedNCT00547287

Eli Lilly and Company2,760 enrolled

Overview

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

2,760

Conditions

Impotence

Interventions

tadalafilDRUG

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.

sildenafilDRUG

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

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.

São Paulo, Brazil

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.

Time frame: 26 weeks

Data from ClinicalTrials.gov

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