To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Eli Lilly and Company1,933 enrolled

Overview

To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,933

Conditions

Impotence

Interventions

tadalafilDRUG

20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 3 months history of erectile dysfunction (ED) * Anticipate a monogamous relationship with a female sexual partner * Be able to make minimum required sexual intercourse attempts * Abstain from using any other ED treatment Exclusion Criteria: * Other primary sexual disorders * History of penile implant or clinically significant penile deformity * History or current nitrate use * History of certain heart problems * History of certain kidney problems

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.

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15

Time frame: 12 weeks

Secondary Outcomes

Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile

Time frame: 12 weeks

Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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