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To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Primary Purpose

Impotence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tadalafil
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 3 months history of erectile dysfunction (ED)
  • Anticipate a monogamous relationship with a female sexual partner
  • Be able to make minimum required sexual intercourse attempts
  • Abstain from using any other ED treatment

Exclusion Criteria:

  • Other primary sexual disorders
  • History of penile implant or clinically significant penile deformity
  • History or current nitrate use
  • History of certain heart problems
  • History of certain kidney 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 Type

Active Comparator

Arm Label

1

Arm Description

tadalafil

Outcomes

Primary Outcome Measures

Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15

Secondary Outcome Measures

Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile
Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions.

Full Information

First Posted
October 18, 2007
Last Updated
October 18, 2007
Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00547417
Brief Title
To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections
Official Title
An Open-Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Men of Various Populations With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (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
To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1933 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
tadalafil
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.
Primary Outcome Measure Information:
Title
Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile
Time Frame
12 weeks
Title
Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 3 months history of erectile dysfunction (ED) Anticipate a monogamous relationship with a female sexual partner Be able to make minimum required sexual intercourse attempts Abstain from using any other ED treatment Exclusion Criteria: Other primary sexual disorders History of penile implant or clinically significant penile deformity History or current nitrate use History of certain heart problems History of certain kidney 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
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

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