Erectile DysfunctionPhase 4NCT00644956
A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil
A Phase 4 study testing tadalafil and sildenafil in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in 2 countries.
Trial summary
The objective of this study was to determine and compare the minimum time required to achieve penile rigidity greater than or equal to 60% at the base of the penis that is sustained for at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of 100 mg sildenafil citrate and 20 mg… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- 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
- 56 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2003to Nov 2003
- 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
- Included subjects were 18 years of age or older
- A clinical diagnosis of erectile dysfunction
- Known responders to either 100 mg sildenafil or 20 mg tadalafil.
Who cannot join
- Excluded were subjects who were unable to achieve penile rigidity of greater than or equal to 20% at the base of the penis that was sustained for at least 3 minutes
- Subjects who are able to achieve penile rigidity of greater than or equal to 60% at the base of the penis that was sustained for for at least 2 minutes or subjects who are able to achieve penile rigidity of greater than or equal to 80% at the base of the penis that is sustained for for at least 1 minute measured by Rigiscan®, at screening with no therapy, within 60 minutes following visual sexual stimulation
- Subjects currently using any commercially available treatments for erectile dysfunction
- Subjects on nitrates.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Viagra (Sildenafil Citrate) And Cialis (Tadalafil)
The objective of this study was to determine and compare the minimum time required to achieve penile rigidity greater than or equal to 60% at the base of the penis that is sustained for at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of 100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).
- Conditions
- Erectile Dysfunction
- 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
tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
sildenafilDrug
sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: sildenafil |
| Arm 2 | Active comparator | Not described Receives: Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable was time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Measured: Screening, Week 0, and Week 1
Secondary outcomes (3)
The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 5 minutes following visual sexual stimulation
Measured: Screening, Week 0, and Week 1
Time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 5 minutes following visual sexual stimulation
Measured: Screening, Week 0, and Week 1
The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Measured: Screening, Week 0, and Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJun 2003
- Study completionNov 2003
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.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644956
- Sponsor's protocol ID
- A1481183
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2008
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Viagra (Sildenafil Citrate) And Cialis (Tadalafil)
- ClinicalTrials.gov ID
- NCT00644956
- Acronym / sponsor ID
- A1481183
- Conditions
- Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Nov 2003 (actual)
- First posted
- 27 Mar 2008 (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 objective of this study was to determine and compare the minimum time required to achieve penile rigidity greater than or equal to 60% at the base of the penis that is sustained for at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of 100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: sildenafil |
| Arm 2 | Active comparator | Drug: tadalafil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Included subjects were 18 years of age or older
- A clinical diagnosis of erectile dysfunction
- Known responders to either 100 mg sildenafil or 20 mg tadalafil.
Key exclusion criteria (4 listed)
- Excluded were subjects who were unable to achieve penile rigidity of greater than or equal to 20% at the base of the penis that was sustained for at least 3 minutes
- Subjects who are able to achieve penile rigidity of greater than or equal to 60% at the base of the penis that was sustained for for at least 2 minutes or subjects who are able to achieve penile rigidity of greater than or equal to 80% at the base of the penis that is sustained for for at least 1 minute measured by Rigiscan®, at screening with no therapy, within 60 minutes following visual sexual stimulation
- Subjects currently using any commercially available treatments for erectile dysfunction
- Subjects on nitrates.
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 |
|---|---|---|
| tadalafiltadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1) | Drug | Arm 2 |
| sildenafilsildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1) | Drug | Arm 1 |
Primary outcome
The primary efficacy variable was time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
3 secondary outcomes
The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 5 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
Time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 5 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
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 1 Feb 2021.
- 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 4 study testing tadalafil and sildenafil in people with Erectile Dysfunction, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 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 3 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 1 Feb 2021. 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 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?
The primary efficacy variable was time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 3 minutes following visual sexual stimulation (time frame: Screening, Week 0, and Week 1). 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 1 Feb 2021.