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Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Primary Purpose

Impotence

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
tadalafil
tadalafil
placebo
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:

  • History of erection problems
  • Anticipate a monogamous female sexual relationship
  • Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
  • Must be able to make required sexual intercourse attempts

Exclusion Criteria:

  • Other primary sexual disorders
  • History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
  • History of penile implant or clinically significant penile deformity
  • Nitrate use
  • Certain heart 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 to 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

10 mg tadalafil tablet

20 mg tadalafil tablet

placebo tablet

Outcomes

Primary Outcome Measures

IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.

Secondary Outcome Measures

IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary

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
NCT00547573
Brief Title
Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
Official Title
A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (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 determine if tadalafil works better than placebo for Asian men having trouble getting or keeping 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
10 mg tadalafil tablet
Arm Title
3
Arm Type
Active Comparator
Arm Description
20 mg tadalafil tablet
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo tablet
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
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 for 12 weeks not more than once a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet taken by mouth as needed for 12 weeks not more than once a day
Primary Outcome Measure Information:
Title
IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.
Time Frame
4, 8, and 12 weeks
Secondary Outcome Measure Information:
Title
IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary
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 erection problems Anticipate a monogamous female sexual relationship Abstain from other erection treatments at least 4 weeks before first dose and throughout the study Must be able to make required sexual intercourse attempts Exclusion Criteria: Other primary sexual disorders History of radical prostatectomy or other pelvic surgery that affected being able to have an erection History of penile implant or clinically significant penile deformity Nitrate use Certain heart 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 to your personal physician.
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

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