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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Additional relevant MeSH terms:
Tadalafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on September 18, 2014