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

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ClinicalTrials.gov Identifier: NCT00547508
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Impotence Drug: tadalafil Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2002
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
Placebo Comparator: 1
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

Placebo Comparator: 2
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

Active Comparator: 3
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
Other Names:
  • LY450190
  • Cialis
  • IC351

Active Comparator: 4
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
Other Names:
  • LY450190
  • Cialis
  • IC351

Active Comparator: 5
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
Other Names:
  • LY450190
  • Cialis
  • IC351

Active Comparator: 6
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
Other Names:
  • LY450190
  • Cialis
  • IC351




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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00547508     History of Changes
Other Study ID Numbers: 7004
H6D-MC-LVFD
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents