ImpotencePhase 2NCT00273416
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
A Phase 2 study testing PF-00592379 and Sildenafil 100mg in people with Impotence, run by Pfizer at 2 sites in 2 countries.
Trial summary
The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Impotence
- What is being tested?
- PF-00592379 and Sildenafil 100mg
- How many people
- 32 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2006to not given
- Phase
- Phase 2
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction.
Who cannot join
- Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
- Patients on nitrates or alpha-blocker medications.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Pfizer Investigational Site
Belfast, Northern Ireland, BT9 6AD
About this study
Official title: A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00592379 On Erectile Function, Using 100mg Sildenafil As A Positive Control
The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).
- Conditions
- Impotence
- Being tested
- PF-00592379, Sildenafil 100mg
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00592379Drug
Sildenafil 100mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Secondary outcomes (1)
Duration and quality of penile erections recorded in a self-assessment diary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
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 PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273416
- Sponsor's protocol ID
- A7771002
- Status last verified
- Aug 2006
- First submitted
- 4 Jan 2006
- Last updated
- 24 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00592379 On Erectile Function, Using 100mg Sildenafil As A Positive Control
- ClinicalTrials.gov ID
- NCT00273416
- Acronym / sponsor ID
- A7771002
- Conditions
- Impotence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 9 Jan 2006 (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.
The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction.
Key exclusion criteria (2 listed)
- Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
- Patients on nitrates or alpha-blocker medications.
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 |
|---|---|---|
| PF-00592379 | Drug | – |
| Sildenafil 100mg | Drug | – |
Primary outcome
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
1 secondary outcome
Duration and quality of penile erections recorded in a self-assessment diary.
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 24 Aug 2006.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00592379 and Sildenafil 100mg in people with Impotence, run by Pfizer at 2 sites in 2 countries.
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 1 inclusion and 2 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 24 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).. 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 24 Aug 2006.