Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

This study has been completed.
ICOS Corporation
Information provided by:
Eli Lilly and Company Identifier:
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.

Condition Intervention Phase
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, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change from baseline to endpoint of various questions from the IIEF and SEP diary [ Time Frame: 12 weeks ]

Enrollment: 343
Study Start Date: March 2004
Study Completion Date: November 2004
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablet
Drug: placebo
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
Active Comparator: 2
5 mg tadalafil
Drug: tadalafil
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 3
10 mg tadalafil
Drug: tadalafil
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 4
20 mg tadalafil
Drug: tadalafil
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
  • LY450190
  • Cialis
  • IC351


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

  • Other primary sexual disorders
  • History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
  • History of penile implant or clinically significant penile deformity.
  • Nitrate use
  • Certain heart problems
  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 identifier: NCT00547495

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.
Sapporo, Hokkaido, Japan
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
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 Identifier: NCT00547495     History of Changes
Other Study ID Numbers: 5139, H6D-MC-LVDI
Study First Received: October 18, 2007
Last Updated: October 18, 2007
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents processed this record on February 26, 2015