Penile EnhancementPhase 3NCT02833532
A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement
A Phase 3 study testing Volus/Powerfill in people with Penile Enhancement, run by Hugel at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Penile Enhancement
- What is being tested?
- Volus/Powerfill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Jun 2017
- 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 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects aged above 20 and below 65. (20≤male≥65)
- be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
- During the study period, subjects will not received any treatments associated with penile enhancement.
- Subjects will sign an informed consent form
Who cannot join
- Prior treatment for penile enhancement (e.g. fat, dermal graft).
- Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
- Allergic to hyalluronic acid.
- Inflammatory or/and infectious disease on penis that can affect on this study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.
- Conditions
- Penile Enhancement
- Being tested
- Volus/Powerfill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volus/PowerfillDevice
Maximum: 22ml
| Study group | Role | What they receive |
|---|---|---|
| Volus | Experimental | Maxium: 22ml Receives: Device: Volus/Powerfill |
| Powerfill | Active comparator | Maxium: 22ml Receives: Device: Volus/Powerfill |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.
Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention.
Measured: baseline, 24 weeks
Secondary outcomes (4)
The Difference in Penile Circumference (each to be measured) at 4, 12 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.
Measured: baseline, 4 weeks, 12 weeks, 24 weeks
The Difference in 5-point scale of penile appearance (each to be measured) at 4, 12, 24 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.
Measured: baseline, 4 weeks, 12 weeks, 24 weeks
The Difference in 5-point scale of sexual satisfaction (each to be measured) at 12, 24 weeks (post last treatment)from Baseline value after using Volus application, compared to the Control.
Measured: baseline, 12 weeks, 24 weeks
The Difference in penile length† (each to be measured) at 4, 12, 24 weeks (post last treatment) from ‡B after using Volus application, compared to the Control.
† penile length: A length of penile distribution measured from the ventral side of pubo-penile skin junction to the apex of prepuce when relaxed using a tape( or stick)- measure.
Measured: baseline, 4 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Penile EnhancementStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833532
- Sponsor's protocol ID
- AC-Volus-01
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang DY, Ko K, Lee SH, Lee WK. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med. 2019 Apr;16(4):577-585. doi: 10.1016/j.jsxm.2019.01.310. Epub 2019 Mar 2.
PubMed 30833149
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement
- ClinicalTrials.gov ID
- NCT02833532
- Acronym / sponsor ID
- AC-Volus-01
- Conditions
- Penile Enhancement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Collaborators
- Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volus | Experimental | Device: Volus/PowerfillMaxium: 22ml |
| Powerfill | Active comparator | Device: Volus/PowerfillMaxium: 22ml |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subjects aged above 20 and below 65. (20≤male≥65)
- be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
- During the study period, subjects will not received any treatments associated with penile enhancement.
- Subjects will sign an informed consent form
Key exclusion criteria (4 listed)
- Prior treatment for penile enhancement (e.g. fat, dermal graft).
- Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
- Allergic to hyalluronic acid.
- Inflammatory or/and infectious disease on penis that can affect on this study
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 |
|---|---|---|
| Volus/PowerfillMaximum: 22ml | Device | Powerfill, Volus |
Primary outcome
the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.
Time frame: baseline, 24 weeks
Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention.
4 secondary outcomes
The Difference in Penile Circumference (each to be measured) at 4, 12 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.
Time frame: baseline, 4 weeks, 12 weeks, 24 weeks
The Difference in 5-point scale of penile appearance (each to be measured) at 4, 12, 24 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.
Time frame: baseline, 4 weeks, 12 weeks, 24 weeks
The Difference in 5-point scale of sexual satisfaction (each to be measured) at 12, 24 weeks (post last treatment)from Baseline value after using Volus application, compared to the Control.
Time frame: baseline, 12 weeks, 24 weeks
The Difference in penile length† (each to be measured) at 4, 12, 24 weeks (post last treatment) from ‡B after using Volus application, compared to the Control.
Time frame: baseline, 4 weeks, 12 weeks, 24 weeks
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 8 Aug 2017.
- Derived from this study: PubMed 30833149Yang DY, Ko K, Lee SH, Lee WK. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med. 2019 Apr;16(4):577-585. doi: 10.1016/j.jsxm.2019.01.310. Epub 2019 Mar 2.
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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 Volus/Powerfill in people with Penile Enhancement, run by Hugel at 1 site in South Korea.
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 4 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 8 Aug 2017. 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 South Korea. 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?
the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control. (time frame: baseline, 24 weeks). 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 NCT02833532, which also lists 1 linked publication.
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 8 Aug 2017.