Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Impotence
Intervention: tadalafil (Drug); placebo (Drug); tadalafil (Drug); tadalafil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
Summary
Study to determine how safe and effective tadalafil is for Japanese men taking it when they
need to get and keep an erection.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: Change from baseline to endpoint of various questions from the IIEF and SEP diary
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
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
Additional Information
Lilly Clinical Trial Registry
Starting date: March 2004
Ending date: November 2004
Last updated: October 18, 2007
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