Erectile DysfunctionPhase 4NCT01698684
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
A Phase 4 study testing Avanafil 100 mg and Avanafil 200 mg in people with Erectile Dysfunction, run by VIVUS LLC at 3 sites in United States.
Trial summary
The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction 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?
- Avanafil 100 mg and Avanafil 200 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males ≥ 18 years of age;
- Minimum 6 months of erectile dysfunction;
- In a monogamous, heterosexual relationship for at least 3 months;
- Agree to make at least 4 attempts at intercourse per month;
- Provide written informed consent;
- Agree not to use any other ED treatments for erectile dysfunction;
- Willing and able to comply with all study requirements.
Who cannot join
- Allergy or hypersensitivity to PDE5 inhibitors;
- History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;
- Concomitant use of one or more of the following medications:
- Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme;
- Dose of an alpha blocker that has not been stable for at least 14 days;
- Any nitrate;
Show all 18Show fewer
- ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
- Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
- Unstable angina, angina with sexual intercourse, or congestive heart failure > NYHA Class II;
- Poorly controlled type 1 or type 2 diabetes;
- Evidence of prostate cancer or previous radical prostatectomy;
- Untreated hypogonadism or total testosterone levels outside normal reference range;
- Abnormal laboratory value(s) judged to be clinically significant by the investigator;
- Positive urine drug screen;
- History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma;
- Previous participation in any other study with avanafil;
- Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study;
- Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Jupiter, Florida
Study site
Raleigh, North Carolina
Study site
Wilmington, North Carolina
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men With Erectile Dysfunction
The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction
- Conditions
- Erectile Dysfunction
- Being tested
- Placebo, Avanafil 100 mg, Avanafil 200 mg
- Keywords
- ED
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
One dose 15 minutes before attempting intercourse
Avanafil 100 mgDrug
One dose 15 minutes before attempting intercourse
Avanafil 200 mgDrug
One dose 15 minutes before attempting intercourse
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Avanafil 100 mg | Experimental | Not described Receives: Drug: Avanafil 100 mg |
| Avanafil 200 mg | Experimental | Not described Receives: Drug: Avanafil 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing
Measured: Week 0 (Baseline) up to Week 8 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chuck Bowden, M.D., Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698684
- Sponsor's protocol ID
- TA-501
- Status last verified
- Oct 2014
- First submitted
- 25 Sep 2012
- Last updated
- 27 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01698684
- Acronym / sponsor ID
- TA-501
- Conditions
- Erectile Dysfunction
- Keywords
- ED
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Posted 27 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Avanafil 100 mg | Experimental | Drug: Avanafil 100 mg |
| Avanafil 200 mg | Experimental | Drug: Avanafil 200 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males ≥ 18 years of age;
- Minimum 6 months of erectile dysfunction;
- In a monogamous, heterosexual relationship for at least 3 months;
- Agree to make at least 4 attempts at intercourse per month;
- Provide written informed consent;
Key exclusion criteria (18 listed)
- Allergy or hypersensitivity to PDE5 inhibitors;
- History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;
- Concomitant use of one or more of the following medications:
- ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
- Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
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 |
|---|---|---|
| PlaceboOne dose 15 minutes before attempting intercourse | Drug | Placebo |
| Avanafil 100 mgOne dose 15 minutes before attempting intercourse | Drug | Avanafil 100 mg |
| Avanafil 200 mgOne dose 15 minutes before attempting intercourse | Drug | Avanafil 200 mg |
Primary outcome
Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing
Time frame: Week 0 (Baseline) up to Week 8 (End of Study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chuck Bowden, M.D. study director
VIVUS LLC
3 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 Avanafil 100 mg and Avanafil 200 mg in people with Erectile Dysfunction, run by VIVUS LLC at 3 sites in United States.
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 7 inclusion and 18 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 27 Oct 2014. 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 States. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing (time frame: Week 0 (Baseline) up to Week 8 (End of Study)). 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 27 Oct 2014.