Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

Phase 4CompletedNCT00547092

Eli Lilly and Company386 enrolled

Overview

To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

386

Conditions

Impotence

Interventions

tadalafilDRUG

10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

sildenafilDRUG

25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of erection problems * Never taken treatments known as PDE5 inhibitors for erection issues * Abstain from using any other erection treatments during the study * Anticipate a monogamous female sexual relationship * Must be able to make required sexual intercourse attempts 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.

Plymouth, United Kingdom

Outcomes

Primary Outcomes

Preference Assessment measured by the Treatment Preference Question

Time frame: 26 weeks

Secondary Outcomes

Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.

Time frame: 0, 12, and 26 weeks

Assess sexual encounters attributes measured by the PAIRS.

Time frame: 0, 12, and 26 weeks

Measure adverse events through the Side Effect Question.

Time frame: 12 and 26 weeks

Data from ClinicalTrials.gov

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