Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

Eli Lilly and Company343 enrolled

Overview

Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

343

Conditions

Impotence

Interventions

tadalafilDRUG

5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks

placeboDRUG

placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks

tadalafilDRUG

10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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

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.

Sapporo, Hokkaido, Japan

Outcomes

Primary Outcomes

Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary

Time frame: 12 weeks

Secondary Outcomes

Change from baseline to endpoint of various questions from the IIEF and SEP diary

Time frame: 12 weeks

Data from ClinicalTrials.gov

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