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

Sponsors and Collaborators:	Eli Lilly and Company ICOS Corporation
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00547508

Purpose

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.

Condition	Intervention	Phase
Impotence	Drug: tadalafil Drug: placebo	Phase III

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Tadalafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

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 [ Time Frame: 6-10 and 24 weeks ]

Enrollment:	485
Study Start Date:	October 2002
Study Completion Date:	September 2003

Arms	Assigned Interventions
1: Placebo Comparator Placebo	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
2: Placebo Comparator Placebo	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
3: Active Comparator tadalafil	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
4: Active Comparator tadalafil	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
5: Active Comparator tadalafil	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
6: Active Comparator tadalafil	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547508

Locations

United States, Tennessee
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.
Knoxville, Tennessee, United States

Sponsors and Collaborators

Eli Lilly and Company

ICOS Corporation

Investigators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	7004, H6D-MC-LVFD
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00547508 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders

Tadalafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders
Tadalafil

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009