ImpotencePhase 4NCT00547092
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
A Phase 4 study testing tadalafil and sildenafil in people with Impotence, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs. 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 and sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Nov 2004
- Phase
- Phase 4
- 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
- History of erection problems
- Never taken treatments known as PDE5 inhibitors for erection issues
- Abstain from using any other erection treatments during the study
- Anticipate a monogamous female sexual relationship
- Must be able to make required sexual intercourse attempts
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 Kingdom1 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.
Plymouth
About this study
Official title: A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.
- Conditions
- Impotence
- Being tested
- tadalafil, sildenafil
- 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 or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
sildenafilDrug
25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks. Receives: Drug: tadalafil |
| 2 | Active comparator | sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks. Receives: Drug: sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference Assessment measured by the Treatment Preference Question
Measured: 26 weeks
Secondary outcomes (3)
Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.
Measured: 0, 12, and 26 weeks
Assess sexual encounters attributes measured by the PAIRS.
Measured: 0, 12, and 26 weeks
Measure adverse events through the Side Effect Question.
Measured: 12 and 26 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 2003
- Study completionNov 2004
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 386 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
- NCT00547092
- Sponsor's protocol ID
- 7002
- Other IDs
- H6D-MC-LVFL
- 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 Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00547092
- Acronym / sponsor ID
- 7002
- Conditions
- Impotence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation
- Study start
- Oct 2003
- Study completion
- Nov 2004 (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.
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tadalafiltadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks. |
| 2 | Active comparator | Drug: sildenafilsildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of erection problems
- Never taken treatments known as PDE5 inhibitors for erection issues
- Abstain from using any other erection treatments during the study
- Anticipate a monogamous female sexual relationship
- Must be able to make required sexual intercourse attempts
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 or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase) | Drug | 1 |
| sildenafil25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase) | Drug | 2 |
Primary outcome
Preference Assessment measured by the Treatment Preference Question
Time frame: 26 weeks
3 secondary outcomes
Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.
Time frame: 0, 12, and 26 weeks
Assess sexual encounters attributes measured by the PAIRS.
Time frame: 0, 12, and 26 weeks
Measure adverse events through the Side Effect Question.
Time frame: 12 and 26 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 4 study testing tadalafil and sildenafil in people with Impotence, run by Eli Lilly and Company at 1 site in United Kingdom.
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 5 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 Kingdom. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Preference Assessment measured by the Treatment Preference Question (time frame: 26 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.