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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547495
First Posted: October 22, 2007
Last Update Posted: October 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
  Purpose
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
Impotence Drug: tadalafil Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00547495


Locations
Japan
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
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:
ClinicalTrials.gov Identifier: NCT00547495     History of Changes
Other Study ID Numbers: 5139
H6D-MC-LVDI
First Submitted: October 18, 2007
First Posted: October 22, 2007
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