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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00547183
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
ICOS Corporation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Impotence Drug: tadalafil Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
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
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 3
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
Other Names:
  • LY450190
  • Cialis
  • IC351
Placebo Comparator: 1 Drug: placebo
Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks

Primary Outcome Measures :
  1. 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 :
  1. Change in the GAQ, SEP, IIEF, SEAR, and RSE scores. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547183

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
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00547183     History of Changes
Other Study ID Numbers: 8702
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents