ImpotencePhase 3NCT00547508
To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking
A Phase 3 study testing tadalafil in people with Impotence, run by Eli Lilly and Company at 1 site in United States.
Trial summary
Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours. 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
- 485 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Sep 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- At least 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
Who cannot join
- History of other primary sexual disorder
- Treatment with nitrates
- Have a penile implant or clinically significant penile deformity
- History of certain heart problems
- Do not meet certain lab value reference ranges
Trial locations and contacts
1 site in 1 country.
United States1 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 with your personal physician.
Knoxville, Tennessee
About this study
Official title: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study in Men With Erectile Dysfunction to Evaluate the Efficacy and Safety of Tadalafil When Sexual Attempts Occur at Specific Time Points After Dosing
Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.
- 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 tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
placeboDrug
Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
tadalafilDrug
Also called LY450190, Cialis, IC351
20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
tadalafilDrug
Also called LY450190, Cialis, IC351
20 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
tadalafilDrug
Also called LY450190, Cialis, IC351
10 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
placeboDrug
Placebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: placebo |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
| 3 | Active comparator | tadalafil Receives: Drug: tadalafil |
| 4 | Active comparator | tadalafil Receives: Drug: tadalafil |
| 5 | Active comparator | tadalafil Receives: Drug: tadalafil |
| 6 | Active comparator | tadalafil Receives: Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prove superiority to placebo by measuring question 3 of the SEP diary
Measured: 6-10 and 24 weeks
Secondary outcomes (1)
Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary
Measured: 6-10 and 24 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 startOct 2002
- Study completionSep 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 485 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
- NCT00547508
- Sponsor's protocol ID
- 7004
- Other IDs
- H6D-MC-LVFD
- Status last verified
- Oct 2007
- First submitted
- 18 Oct 2007
- Last updated
- 22 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel, Placebo-Controlled Study in Men With Erectile Dysfunction to Evaluate the Efficacy and Safety of Tadalafil When Sexual Attempts Occur at Specific Time Points After Dosing
- ClinicalTrials.gov ID
- NCT00547508
- Acronym / sponsor ID
- 7004
- Conditions
- Impotence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation
- Study start
- Oct 2002
- Study completion
- Sep 2003 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboPlacebo |
| 2 | Placebo comparator | Drug: placeboPlacebo |
| 3 | Active comparator | Drug: tadalafiltadalafil |
| 4 | Active comparator | Drug: tadalafiltadalafil |
| 5 | Active comparator | Drug: tadalafiltadalafil |
| 6 | Active comparator | Drug: tadalafiltadalafil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 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
Key exclusion criteria (5 listed)
- History of other primary sexual disorder
- Treatment with nitrates
- Have a penile implant or clinically significant penile deformity
- History of certain heart problems
- Do not meet certain lab value reference ranges
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tadalafilAlso: LY450190, Cialis, IC35110 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase | Drug | 4 |
| placeboPlacebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase | Drug | 1 |
| tadalafilAlso: LY450190, Cialis, IC35120 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 24 hours prior to sexual intercourse for 4-6 weeks in the assessment phase | Drug | 5 |
| tadalafilAlso: LY450190, Cialis, IC35120 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase | Drug | 6 |
| tadalafilAlso: LY450190, Cialis, IC35110 mg tablet taken orally, no more than once a day, at anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase | Drug | 3 |
| placeboPlacebo tablet taken by mouth, no more than once a day, anytime during the 2-4 week equilibration phase and then 36 hours prior to sexual intercourse for 4-6 weeks in the assessment phase | Drug | 2 |
Primary outcome
Prove superiority to placebo by measuring question 3 of the SEP diary
Time frame: 6-10 and 24 weeks
1 secondary outcome
Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary
Time frame: 6-10 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tadalafil in people with Impotence, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prove superiority to placebo by measuring question 3 of the SEP diary (time frame: 6-10 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2007.