Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
Primary Purpose
Impotence
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
tadalafil
tadalafil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility 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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
2
3
1
Arm Description
2.5 mg tadalafil
5 mg tadalafil
Outcomes
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
Secondary Outcome Measures
Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.
Full Information
NCT ID
NCT00547183
First Posted
October 18, 2007
Last Updated
October 18, 2007
Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00547183
Brief Title
Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
2.5 mg tadalafil
Arm Title
3
Arm Type
Active Comparator
Arm Description
5 mg tadalafil
Arm Title
1
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Genthin
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24119319
Citation
Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
Results Reference
derived
PubMed Identifier
23035781
Citation
Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.
Results Reference
derived
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Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
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