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

This study has been completed.
ICOS Corporation
Information provided by:
Eli Lilly and Company Identifier:
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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
Drug: tadalafil
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00547183     History of Changes
Other Study ID Numbers: 8702
Study First Received: October 18, 2007
Last Updated: October 18, 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 processed this record on May 22, 2017