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

This study has been completed.

First Received: October 18, 2007 No Changes Posted

Sponsors and Collaborators:	Eli Lilly and Company ICOS Corporation
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00547183

Purpose

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.

Condition	Intervention	Phase
Impotence	Drug: tadalafil Drug: placebo	Phase III

MedlinePlus related topics: Diabetes Erectile Dysfunction

Drug Information available for: Tadalafil

U.S. FDA Resources

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome 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 Outcome Measures:

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

Enrollment:	298
Study Start Date:	October 2004
Study Completion Date:	May 2005

Arms	Assigned Interventions
2: Active Comparator 2.5 mg tadalafil	Drug: tadalafil 2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
3: Active Comparator 5 mg tadalafil	Drug: tadalafil 5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
1: Placebo Comparator	Drug: placebo Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547183

Locations

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, Germany

Sponsors and Collaborators

Eli Lilly and Company

ICOS Corporation

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	8702, H6D-MC-LVFZ
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00547183 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders

Tadalafil
Diabetes Mellitus
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders
Tadalafil

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009