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Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00547352
Enrollment
160
Registered
2007-10-22
Start date
2004-06-30
Completion date
2005-06-30
Last updated
2007-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impotence

Brief summary

To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil.

Interventions

DRUGtadalafil

20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.

DRUGsildenafil

Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.

Sponsors

ICOS Corporation
CollaboratorINDUSTRY
Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* History of erection problems * Anticipate a monogamous female sexual relationship * Abstain from other erection treatments throughout the study * Currently use sildenafil

Exclusion criteria

* Other primary sexual disorders * History of radical prostatectomy or other pelvic surgery that affected being able to have an erection * History of penile implant or clinically significant penile deformity. * Nitrate use * Certain heart problems

Design outcomes

Primary

MeasureTime frame
Patient choice of drug at visit 514-15 weeks

Secondary

MeasureTime frame
PAIRS self-administered scale scores14-15 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026