ImpotencePhase 3NCT00547573
Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
A Phase 3 study testing tadalafil in people with Impotence, run by Eli Lilly and Company at 1 site in China.
Trial summary
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Impotence
- What is being tested?
- tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 1 siteChina
- Study dates
- Apr 2003to Dec 2003
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
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
About this study
Official title: 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
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.
- Conditions
- Impotence
- Being tested
- tadalafil, placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tadalafilDrug
Also called LY450190, Cialis, IC351
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
tadalafilDrug
Also called LY450190, Cialis, IC351
20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
placeboDrug
placebo tablet taken by mouth as needed for 12 weeks not more than once a day
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | 10 mg tadalafil tablet Receives: Drug: tadalafil |
| 3 | Active comparator | 20 mg tadalafil tablet Receives: Drug: tadalafil |
| 1 | Placebo comparator | placebo tablet Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4, 8, and 12 weeks
Secondary outcomes (1)
IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startApr 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation
- Investigators
- 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, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547573
- Sponsor's protocol ID
- 5874
- Other IDs
- H6D-MC-LVDY
- Status last verified
- Oct 2007
- First submitted
- 18 Oct 2007
- Last updated
- 22 Oct 2007
- Results posted
- No
- Data monitoring committee
- No