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To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

Primary Purpose

Impotence

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

tadalafil

placebo

tadalafil

placebo

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:

History of other primary sexual disorder
Treatment with nitrates
Have a penile implant or clinically significant penile deformity
History of certain heart problems
Do not meet certain lab value reference ranges

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 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Placebo

tadalafil

Outcomes

Primary Outcome Measures

Prove superiority to placebo by measuring question 3 of the SEP diary

Secondary Outcome Measures

Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary

Full Information

NCT ID

NCT00547508

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

NCT00547508

Brief Title

To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

Official Title

A Randomized, Double-Blind, Parallel, Placebo-Controlled Study in Men With Erectile Dysfunction to Evaluate the Efficacy and Safety of Tadalafil When Sexual Attempts Occur at Specific Time Points After Dosing

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

Collaborators

ICOS Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.

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

485 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Active Comparator

Arm Description

tadalafil

Arm Title

Arm Type

Active Comparator

Arm Description

tadalafil

Arm Title

Arm Type

Active Comparator

Arm Description

tadalafil

Arm Title

Arm Type

Active Comparator

Arm Description

tadalafil

Intervention Type

Drug

Intervention Name(s)

tadalafil

Other Intervention Name(s)

LY450190, Cialis, IC351

Intervention Description

10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase

Intervention Type

Drug

Intervention Name(s)

tadalafil

Other Intervention Name(s)

LY450190, Cialis, IC351

Intervention Description

20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase

Intervention Type

Drug

Intervention Name(s)

tadalafil

Other Intervention Name(s)

LY450190, Cialis, IC351

Intervention Description

20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase

Intervention Type

Drug

Intervention Name(s)

tadalafil

Other Intervention Name(s)

LY450190, Cialis, IC351

Intervention Description

10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase

Primary Outcome Measure Information:

Title

Prove superiority to placebo by measuring question 3 of the SEP diary

Time Frame

6-10 and 24 weeks

Secondary Outcome Measure Information:

Title

Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary

Time Frame

6-10 and 24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: History of other primary sexual disorder Treatment with nitrates Have a penile implant or clinically significant penile deformity History of certain heart problems Do not meet certain lab value reference ranges

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

Knoxville

State/Province

Tennessee

Country

United States

12. IPD Sharing Statement

Learn more about this trial

To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

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