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

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547183
• Other study ID #: 8702
• Secondary ID: H6D-MC-LVFZ
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: October 18, 2007
• Start date: October 2004
• Est. completion date: May 2005

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impotence

Intervention

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

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.		12 weeks

External Links

•   Lilly Clinical Trial Registry