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

This study has been completed.

Sponsor:

Collaborator:

ICOS Corporation

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00547508

First received: October 18, 2007

Last updated: NA

Last verified: October 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 18, 2007

Last Updated Date

October 18, 2007

Start Date ^ICMJE

October 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Prove superiority to placebo by measuring question 3 of the SEP diary [ Time Frame: 6-10 and 24 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Impotence

Intervention ^ICMJE

Drug: tadalafil
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
Other Names:
- LY450190
- Cialis
- IC351
Drug: placebo
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
Drug: tadalafil
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
Other Names:
- LY450190
- Cialis
- IC351
Drug: tadalafil
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
Other Names:
- LY450190
- Cialis
- IC351
Drug: tadalafil
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
Other Names:
- LY450190
- Cialis
- IC351
Drug: placebo
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

Study Arm (s)

Placebo Comparator: 1
Placebo

Intervention: Drug: placebo
Placebo Comparator: 2
Placebo

Intervention: Drug: placebo
Active Comparator: 3
tadalafil

Intervention: Drug: tadalafil
Active Comparator: 4
tadalafil

Intervention: Drug: tadalafil
Active Comparator: 5
tadalafil

Intervention: Drug: tadalafil
Active Comparator: 6
tadalafil

Intervention: Drug: tadalafil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

485

Completion Date

September 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00547508

Other Study ID Numbers ^ICMJE

7004, H6D-MC-LVFD

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

ICOS Corporation

Investigators ^ICMJE

Study Director:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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