Erectile DysfunctionPhase 2NCT00862888
Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction
A Phase 2 study testing PF-00446687 and Sildenafil in people with Erectile Dysfunction, run by Pfizer at 3 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- PF-00446687 and Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2007to Feb 2008
- 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
- Males aged 18-65 years who has given written informed consent to participate in the study and who suffers moderate to severe erectile dysfunction who has a current or recent successful response to treatment with phosphodiesterase type 5 inhibitors
Who cannot join
- Males with a history of significant cardiac disease; unstable angina or recent myocardial infarction.
- Males suffering from treated or untreated hypo- or hypertension
- Males currently receiving vasoactive medication
- Males taking medications contraindicated, or cautioned with sildenafil or MC4 agonists
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Pfizer Investigational Site
Belfast, Northern Ireland, BT9 6AD
Pfizer Investigational Site
Leeds, WEST Yorkshire, LS2 9LH
About this study
Official title: A 2-Cohort, Multi-Centre, Randomised, Double Blind, Placebo Controlled 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00446687 On Erectile Function In Men Suffering From Erectile Dysfunction, Using 100 Mg Sildenafil As A Positive Control.
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.
- Conditions
- Erectile Dysfunction
- Being tested
- PF-00446687, Placebo, 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.
PF-00446687Drug
Single 200mg dose as an oral solution
PlaceboDrug
Placebo for oral solution
PlaceboDrug
Placebo for tablet
SildenafilDrug
Single oral dose 100 mg tablet
PF-00446687Drug
Single 125 mg dose as an oral solution
PF-00446687Drug
Single 175 mg dose as an oral solution
PF-00446687Drug
Single 20 mg dose as an oral solution
PlaceboDrug
Placebo for oral solution
PlaceboDrug
Placebo for tablet
SildenafilDrug
Single oral dose 100 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1; Study Period 1, 2, 3 or 4 | Placebo comparator | Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design) Receives: Drug: PF-00446687; Drug: Placebo; Drug: Sildenafil |
| Cohort 2; study periods 1, 2, 3 or 4 | Placebo comparator | Cohort 2: Exploring single doses of PF-00446687 20 mg - 175 mg. Subjects to receive two of 3 possible doses of PF-00446687 as well as a single dose of sildenafil 100mg and placebo (double dummy design). Receives: Drug: PF-00446687; Drug: Placebo; Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)
Measured: Day of dosing
Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire
Measured: Day of dosing
Diary of sexual activities
Measured: From day of dosing to 7 days post-dose
Secondary outcomes (4)
PK assessment of PF-00446687 ad sildenafil
Measured: Day of dosing
Safety and toleration
Measured: Day of dosing to follow-up
Assess variability of response and repeatability of design between 2 similar doses
Measured: Comparison of response to be assessed until 7 days post-dose
Assess agouti related protein levels in this population
Measured: Day of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startJul 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
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
- NCT00862888
- Sponsor's protocol ID
- A8361011
- Status last verified
- Apr 2009
- First submitted
- 16 Mar 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Cohort, Multi-Centre, Randomised, Double Blind, Placebo Controlled 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00446687 On Erectile Function In Men Suffering From Erectile Dysfunction, Using 100 Mg Sildenafil As A Positive Control.
- ClinicalTrials.gov ID
- NCT00862888
- Acronym / sponsor ID
- A8361011
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 Mar 2009 (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 purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1; Study Period 1, 2, 3 or 4 | Placebo comparator | Drug: PF-00446687, Drug: Placebo, Drug: SildenafilCohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design) |
| Cohort 2; study periods 1, 2, 3 or 4 | Placebo comparator | Drug: PF-00446687, Drug: Placebo, Drug: SildenafilCohort 2: Exploring single doses of PF-00446687 20 mg - 175 mg. Subjects to receive two of 3 possible doses of PF-00446687 as well as a single dose of sildenafil 100mg and placebo (double dummy design). |
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)
- Males aged 18-65 years who has given written informed consent to participate in the study and who suffers moderate to severe erectile dysfunction who has a current or recent successful response to treatment with phosphodiesterase type 5 inhibitors
Key exclusion criteria (4 listed)
- Males with a history of significant cardiac disease; unstable angina or recent myocardial infarction.
- Males suffering from treated or untreated hypo- or hypertension
- Males currently receiving vasoactive medication
- Males taking medications contraindicated, or cautioned with sildenafil or MC4 agonists
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-00446687Single 200mg dose as an oral solution | Drug | Cohort 1; Study Period 1, 2, 3 or 4 |
| PlaceboPlacebo for oral solution | Drug | Cohort 1; Study Period 1, 2, 3 or 4 |
| PlaceboPlacebo for tablet | Drug | Cohort 1; Study Period 1, 2, 3 or 4 |
| SildenafilSingle oral dose 100 mg tablet | Drug | Cohort 1; Study Period 1, 2, 3 or 4 |
| PF-00446687Single 125 mg dose as an oral solution | Drug | Cohort 2; study periods 1, 2, 3 or 4 |
| PF-00446687Single 175 mg dose as an oral solution | Drug | Cohort 2; study periods 1, 2, 3 or 4 |
| PF-00446687Single 20 mg dose as an oral solution | Drug | Cohort 2; study periods 1, 2, 3 or 4 |
| PlaceboPlacebo for oral solution | Drug | Cohort 2; study periods 1, 2, 3 or 4 |
| PlaceboPlacebo for tablet | Drug | Cohort 2; study periods 1, 2, 3 or 4 |
| SildenafilSingle oral dose 100 mg tablet | Drug | Cohort 2; study periods 1, 2, 3 or 4 |
Primary outcome
Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)
Time frame: Day of dosing
Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire
Time frame: Day of dosing
Diary of sexual activities
Time frame: From day of dosing to 7 days post-dose
4 secondary outcomes
PK assessment of PF-00446687 ad sildenafil
Time frame: Day of dosing
Safety and toleration
Time frame: Day of dosing to follow-up
Assess variability of response and repeatability of design between 2 similar doses
Time frame: Comparison of response to be assessed until 7 days post-dose
Assess agouti related protein levels in this population
Time frame: Day of dosing
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 8 Apr 2009.
- 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
3 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-00446687 and Sildenafil in people with Erectile Dysfunction, run by Pfizer at 3 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 4 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 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Norway. 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 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?
Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device) (time frame: Day of dosing). The study lists 3 primary outcomes in all. 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 8 Apr 2009.