Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction
2 other identifiers
interventional
367
1 country
1
Brief Summary
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2003
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 18, 2007
CompletedFirst Posted
Study publicly available on registry
October 22, 2007
CompletedOctober 22, 2007
October 1, 2007
October 18, 2007
October 18, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.
4, 8, and 12 weeks
Secondary Outcomes (1)
IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary
12 weeks
Study Arms (3)
2
ACTIVE COMPARATOR10 mg tadalafil tablet
3
ACTIVE COMPARATOR20 mg tadalafil tablet
1
PLACEBO COMPARATORplacebo tablet
Interventions
Eligibility Criteria
You may qualify if:
- History of erection problems
- Anticipate a monogamous female sexual relationship
- Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
- Must be able to make required sexual intercourse attempts
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- ICOS Corporationcollaborator
Study Sites (1)
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 to your personal physician.
Beijing, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2007
First Posted
October 22, 2007
Study Start
April 1, 2003
Study Completion
December 1, 2003
Last Updated
October 22, 2007
Record last verified: 2007-10