Erectile DisfunctionPhase 4NCT00654017
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis
A Phase 4 study testing sildenafil in people with Erectile Disfunction and Hemodialysis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Brazil.
Trial summary
The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Erectile Disfunction, Hemodialysis
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 8 sitesBrazil
- Study dates
- Oct 2002to Apr 2005
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included patients had been in a stable relationship with a female partner for at least 6 months
- A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile Function (IIEF-5) score of <21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".
Who cannot join
- Patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation
- Patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis)
- Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ED diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period
- Patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30150-260
Pfizer Investigational Site
Belo Horizonte, Minas Gerais
Pfizer Investigational Site
Fortaleza, Ceará, 60430-370
Pfizer Investigational Site
Jaú, São Paulo, 17210-080
Pfizer Investigational Site
Londrina, Paraná, 86010-010
Pfizer Investigational Site
São José do Rio Preto, São Paulo
Pfizer Investigational Site
São Paulo, 01323-001
Pfizer Investigational Site
Sorocaba, São Paulo, 18030-205
About this study
Official title: Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Flexible, Titration Dose Administered on an As Needed Basis (PRN) to Evaluate the Efficacy and the Safety of Sildenafil for the Treatment of Erectile Dysfunction in Male Patients on Hemodialysis
The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.
- Conditions
- Erectile Disfunction, Hemodialysis
- Being tested
- placebo, sildenafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Placebo comparator to be given per protocol.
sildenafilDrug
oral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| sildenafil | Active comparator | Not described Receives: Drug: sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
Measured: Baseline and Week 10
Secondary outcomes (6)
rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful)
Measured: Baseline to Week 10
response to Partner's Satisfaction Questionnaire (optional)
Measured: Week 10
total Score of Quality of Life and erectile dysfunction questionnaire
Measured: Baseline and Week 10
monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate
Measured: Baseline, and Weeks 2, 4, 6, and 10
response to Question 1 of the Global Efficacy Assessment Question
Measured: Week 10
responses to questions of the IIEF
Measured: Baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startOct 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DisfunctionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
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
- NCT00654017
- Sponsor's protocol ID
- A1481076
- Status last verified
- Jan 2021
- First submitted
- 31 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
- Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Flexible, Titration Dose Administered on an As Needed Basis (PRN) to Evaluate the Efficacy and the Safety of Sildenafil for the Treatment of Erectile Dysfunction in Male Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT00654017
- Acronym / sponsor ID
- A1481076
- Conditions
- Erectile Disfunction, Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Apr 2005 (actual)
- First posted
- 7 Apr 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 study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| sildenafil | Active comparator | Drug: sildenafil |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Included patients had been in a stable relationship with a female partner for at least 6 months
- A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile Function (IIEF-5) score of <21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".
Key exclusion criteria (4 listed)
- Patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation
- Patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis)
- Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ED diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period
- Patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.
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 |
|---|---|---|
| placeboPlacebo comparator to be given per protocol. | Drug | placebo |
| sildenafiloral sildenafil citrate at an initial dose of 25 mg, which could have been up-titrated to 50 mg at Visit 3 based on the patient's efficacy, safety and tolerability responses; at Visits 4 and 5, the dose could remain the same, be increased to 100 mg, or decreased to 25 mg depending on the safety, efficacy, and tolerability | Drug | sildenafil |
Primary outcome
Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF).
Time frame: Baseline and Week 10
6 secondary outcomes
rate of successful sexual intercourse (number of attempts at sexual intercourse, number of successful attempts and percentage of attempts that were successful)
Time frame: Baseline to Week 10
response to Partner's Satisfaction Questionnaire (optional)
Time frame: Week 10
total Score of Quality of Life and erectile dysfunction questionnaire
Time frame: Baseline and Week 10
monitoring of adverse events (AEs) and measurement of sitting blood pressure and heart rate
Time frame: Baseline, and Weeks 2, 4, 6, and 10
response to Question 1 of the Global Efficacy Assessment Question
Time frame: Week 10
responses to questions of the IIEF
Time frame: Baseline and Week 10
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sildenafil in people with Erectile Disfunction and Hemodialysis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Brazil.
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 2 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 8 sites in Brazil. 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 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?
Response to questions 3 (frequency of penetration) and 4 (frequency of maintained erection) of the International Index of Erectile Function (IIEF). (time frame: Baseline and Week 10). 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.