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

October 18, 2007 updated by: Eli Lilly and Company

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Genthin, 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Drug: placebo
Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks
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
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
Active Comparator: 3
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

ICOS Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

October 22, 2007

Last Update Submitted That Met QC Criteria

October 18, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8702
  • H6D-MC-LVFZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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