Official Title: “A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
• Drug: tadalafil
  • 5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
• Drug: placebo
  • Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • 2.5 mg tadalafil
• Active Comparator: 3
  • 5 mg tadalafil
• Placebo Comparator: 1

Primary Measures

• 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 Measures

• Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.
  • Time Frame: 12 weeks
    

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547183

Study ID Number: 8702

ClinicalTrials.gov Identifier: NCT00547183

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry