ImpotencePhase 4NCT00143221
Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
A Phase 4 study testing Viagra in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Impotence
- What is being tested?
- Viagra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to May 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of erectile dysfunction (ED)
- lower urinary tract symptoms (LUTS)
Who cannot join
- previous prostate surgery or invasive intervention for BPH
- active urinary tract disease
About this study
Official title: A Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.
- Conditions
- Impotence
- Being tested
- Viagra, Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViagraDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
Secondary outcomes (3)
Effect on: IPSS Effect on IPSS QoL Orgasmic Function
Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
Event Log Variables
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMar 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ImpotenceStudies 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
- Enrolment
- 350 participants
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
- NCT00143221
- Sponsor's protocol ID
- A1481217
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2005
- Last updated
- 1 Feb 2021
- Results posted
- No
Publications
McVary KT, Siegel RL, Carlsson M. Sildenafil citrate improves erectile function and lower urinary tract symptoms independent of baseline body mass index or LUTS severity. Urology. 2008 Sep;72(3):575-9. doi: 10.1016/j.urology.2008.04.020. Epub 2008 Jul 2.
PubMed 18597830McVary KT, Kaufman J, Young JM, Tseng LJ. Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. Int J Clin Pract. 2007 Nov;61(11):1843-9. doi: 10.1111/j.1742-1241.2007.01585.x. Epub 2007 Sep 20.
PubMed 17887993McVary KT, Monnig W, Camps JL Jr, Young JM, Tseng LJ, van den Ende G. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol. 2007 Mar;177(3):1071-7. doi: 10.1016/j.juro.2006.10.055.
PubMed 17296414
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 Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
- ClinicalTrials.gov ID
- NCT00143221
- Acronym / sponsor ID
- A1481217
- Conditions
- Impotence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- May 2005
- First posted
- 2 Sep 2005 (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 determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of erectile dysfunction (ED)
- lower urinary tract symptoms (LUTS)
Key exclusion criteria (2 listed)
- previous prostate surgery or invasive intervention for BPH
- active urinary tract disease
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 |
|---|---|---|
| Viagra | Drug | – |
| Placebo | Drug | – |
Primary outcome
Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
3 secondary outcomes
Effect on: IPSS Effect on IPSS QoL Orgasmic Function
Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
Event Log Variables
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.
- Derived from this study: PubMed 18597830McVary KT, Siegel RL, Carlsson M. Sildenafil citrate improves erectile function and lower urinary tract symptoms independent of baseline body mass index or LUTS severity. Urology. 2008 Sep;72(3):575-9. doi: 10.1016/j.urology.2008.04.020. Epub 2008 Jul 2.
- Derived from this study: PubMed 17887993McVary KT, Kaufman J, Young JM, Tseng LJ. Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. Int J Clin Pract. 2007 Nov;61(11):1843-9. doi: 10.1111/j.1742-1241.2007.01585.x. Epub 2007 Sep 20.
- Derived from this study: PubMed 17296414McVary KT, Monnig W, Camps JL Jr, Young JM, Tseng LJ, van den Ende G. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol. 2007 Mar;177(3):1071-7. doi: 10.1016/j.juro.2006.10.055.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Viagra in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00143221, which also lists 3 linked publications.
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.