Erectile DysfunctionPhase 3NCT02850718
A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer
A Phase 3 study testing Sublingual Sildenafil and Oral Sildenafil in people with Erectile Dysfunction, run by iX Biopharma Ltd. at 1 site in Australia.
Trial summary
A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test sublingual sildenafil wafer. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sublingual Sildenafil and Oral Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2016to May 2016
- Phase
- Phase 3
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily provides signed, written, and dated informed consent prior to any study-specific procedures.
- Healthy male volunteers aged 18-50 years inclusive.
- In good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the Principal Investigator.
- Sufficient access for venous cannulation to withdraw blood as per the study design.
- Body mass index (BMI) of ≥19 to ≤ 30kg/m2 (inclusive).
- Participant is deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.
- Able to refrain from smoking while at the research unit.
Who cannot join
- Past history of hypersensitivity to sildenafil, any of its excipients, or severe allergic or anaphylactic reaction to any other drug.
- A medical condition that, in the opinion of the Investigator, may adversely impact the participant's ability to complete the study, including but not limited to:
- History of priapism;
- History of easy fainting or symptomatic postural hypotension;
- Standing or supine systolic blood pressure < 90mmHg or diastolic blood pressure < 50mm Hg or postural drop of >30mm Hg;
- History of myocardial infarction or clinically significant cardiac disease including cardiac arrhythmia;
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- History of retinitis pigmentosa or optic neuropathy or other risk factors of non-arteritic anterior ischaemic optic neuropathy (NAION);
- History or evidence of hypertension - defined as three BP readings (at rest) within 15 minutes of systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mmHg. Note: serial blood pressure readings are only required if the initial reading is elevated;
- Anaemia (haemoglobin < lower limit of normal for sex).
- Clinically significant 12-lead ECG abnormalities at the screening visit as determined by the Investigator.
- Concomitant consumption of any other medication regularly, with the exception of vitamins or minerals.
- Consumption of drugs with either enzyme-inducing properties, such as rifampicin and St John's Wort, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase or CYP3A4 inhibitors, such as erythromycin and clarithromycin, within 5 half-lives prior to the initial dose of study drug and throughout the treatment phase.
- Previous known or suspected drug abuse (including analgesic drugs or tranquilizers) or dependence, as defined by DSM-IV, or history of alcohol abuse or excessive intake of alcohol, defined as regular weekly intake of >15 units for men and >10 units for women (1 unit= 25ml spirits,125ml wine, 250ml beer or lager).
- Positive results on the urine drug screen indicative of illicit drug abuse or inconsistent with medication history, or alcohol breath test indicative of alcohol abuse.
- History of hepatitis B or C, or other forms of non-infectious liver disease.
- Clinically significant abnormalities in clinical chemistry, haematology, urinalysis, or serology results at screening that, in the opinion of the Investigator, puts the volunteer at risk for study participation.
- Clinically significant plasma AST, ALT and ALP tests (defined as ≥1.5 times the upper limit of normal).
- Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening.
- Prevalent abnormality in the oral cavity which may alter sublingual drug absorption (e.g. recurrent oral ulceration, lichen planus, or xerostomia).
- Any other condition which, in the opinion of the Investigator, makes the volunteer unsuitable for the study.
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to return for follow up visits on schedule.
- Member or relative of study staff or the Sponsor directly involved in the study.
- Previous participation in this study.
- Has received another investigational agent or new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to the Screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test sublingual sildenafil wafer.
Read the detailed description
Healthy volunteers will complete two inpatient study periods and receive either sublingual wafer sildenafil or oral sildenafil. Plasma samples and adverse events will be collected.
- Conditions
- Erectile Dysfunction
- Being tested
- Sublingual Sildenafil, Oral 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.
Sublingual SildenafilDrug
Also called Pheonix
50 mg sildenafil sublingual wafer.
Oral SildenafilDrug
Also called Viagra
50 mg oral sildenafil (Viagra)
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Sublingual wafer | Experimental | Subjects receive receive a single dose of 50 mg sublingual sildenafil followed by plasma sampling for 14 hours. Receives: Drug: Sublingual Sildenafil |
| Period 2: Oral comparator | Active comparator | Subjects receive a single dose of 50 mg oral sildenafil (Viagra) followed by plasma sampling for 14 hours. Receives: Drug: Oral Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sildenafil plasma concentrations
Measured: 1 week
Secondary outcomes (1)
Number of patients with treatment-related adverse events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- iX Biopharma Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Linear Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850718
- Sponsor's protocol ID
- SIL-003
- Status last verified
- Aug 2016
- First submitted
- 12 Apr 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer
- ClinicalTrials.gov ID
- NCT02850718
- Acronym / sponsor ID
- SIL-003
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- iX Biopharma Ltd.University, hospital or other
- Collaborators
- Linear Clinical Research
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Aug 2016 (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.
A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test sublingual sildenafil wafer.
Detailed description
Healthy volunteers will complete two inpatient study periods and receive either sublingual wafer sildenafil or oral sildenafil. Plasma samples and adverse events will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Sublingual wafer | Experimental | Drug: Sublingual SildenafilSubjects receive receive a single dose of 50 mg sublingual sildenafil followed by plasma sampling for 14 hours. |
| Period 2: Oral comparator | Active comparator | Drug: Oral SildenafilSubjects receive a single dose of 50 mg oral sildenafil (Viagra) followed by plasma sampling for 14 hours. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Voluntarily provides signed, written, and dated informed consent prior to any study-specific procedures.
- Healthy male volunteers aged 18-50 years inclusive.
- In good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the Principal Investigator.
- Sufficient access for venous cannulation to withdraw blood as per the study design.
- Body mass index (BMI) of ≥19 to ≤ 30kg/m2 (inclusive).
Key exclusion criteria (24 listed)
- Past history of hypersensitivity to sildenafil, any of its excipients, or severe allergic or anaphylactic reaction to any other drug.
- A medical condition that, in the opinion of the Investigator, may adversely impact the participant's ability to complete the study, including but not limited to:
- Clinically significant 12-lead ECG abnormalities at the screening visit as determined by the Investigator.
- Concomitant consumption of any other medication regularly, with the exception of vitamins or minerals.
- Consumption of drugs with either enzyme-inducing properties, such as rifampicin and St John's Wort, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase or CYP3A4 inhibitors, such as erythromycin and clarithromycin, within 5 half-lives prior to the initial dose of study drug and throughout the treatment phase.
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 |
|---|---|---|
| Sublingual SildenafilAlso: Pheonix50 mg sildenafil sublingual wafer. | Drug | Period 1: Sublingual wafer |
| Oral SildenafilAlso: Viagra50 mg oral sildenafil (Viagra) | Drug | Period 2: Oral comparator |
Primary outcome
Sildenafil plasma concentrations
Time frame: 1 week
1 secondary outcome
Number of patients with treatment-related adverse events
Time frame: 1 week
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 19 Aug 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sublingual Sildenafil and Oral Sildenafil in people with Erectile Dysfunction, run by iX Biopharma Ltd. at 1 site in Australia.
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 24 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Sildenafil plasma concentrations (time frame: 1 week). 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 19 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.