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

Phase 3

Completed

• Conditions: Impotence
• Interventions: Drug: tadalafil; Drug: placebo

• Registration Number: NCT00547183
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-05
• Status Verified: 2007-10
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Last Update Submitted: 2007-10-18
• Study First Posted: 2007-10-22
• Last Update Posted: 2007-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 298

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	tadalafil	5 mg tadalafil
1	placebo	-
2	tadalafil	2.5 mg tadalafil

Primary Outcome Measures

Name	Time	Method
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	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.	12 weeks

Trial Locations

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