Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

Eli Lilly and Company298 enrolled

Overview

Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

298

Conditions

Impotence

Interventions

tadalafilDRUG

2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks

tadalafilDRUG

5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks

placeboDRUG

Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of erectile dysfunction for at least 3 months. * Currently have diabetes mellitus of at least 3 months duration. * Agree to not use any other ED treatment during the study. * Anticipate the same female sexual partner for the study. * Must be willing to make the required number of sexual attempts. Exclusion Criteria: * History of other primary sexual disorder * Treatment with nitrates or potent CYP3A4 inhibitors * Have a penile implant or clinically significant penile deformity * History of certain heart problems * Have kidney or liver 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.

Genthin, Germany

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 the SEP diary

Time frame: 12 weeks

Secondary Outcomes

Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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