Premature EjaculationPhase 3NCT03459833
Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation
A Phase 3 study testing Hyaluronic Acid in people with Premature Ejaculation, run by Cairo University.
Trial summary
This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo . Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2016to Mar 2018
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- occurrence of ejaculation in patients with lifelong premature ejaculation (LL PE) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (A PE), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy
Who cannot join
- Erectile dysfunction
- Hypo or hyperthyroidism
- Hypogonadism
- Hyperprolactinemia
- Drug abuse
- Psychiatric disorders or related medications
About this study
Official title: Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial
This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo .
- Conditions
- Premature Ejaculation
- Being tested
- Hyaluronic Acid
- Keywords
- premature ejaculation, IELT, hyaluronic acid, glans penis augmentation
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
Glans penis augmentation using multiple puncture technique as described by Abdallah et al. (2012) with minor modifications. HA is injected at two circular levels: one at the level of corona of glans penis and a second circular level is mid-way between the corona and urethral meatus. Six injections are injected at coronal level and four are injected in the second level, each injection is of 0.2 ml and is injected into deep dermis.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 15 patients They will receive a topical anesthetic agent for 30 minutes (Emla cream; lidocaine 25 mg, prilocaine 25 mg, Astra Xeneca, Mississauga, Canada) followed by injection of two prefilled 1 ml syringes with 30 G needle of hyaluronic acid (HA; Teosyal® PureSense Global Action, Teoxane Laboratories, Geneva, Switzerland). After 18 months from the HA injection, cross-over to placebo arm will be done. Receives: Drug: Hyaluronic Acid |
| group 2 | Placebo comparator | They receive by the same method 2 ml saline as a placebo. After one month of the injection, cross-over to HA arm will be done. Receives: Drug: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
IELT
Intra-vaginal Ejaculation Latency Time
Measured: Change from baseline after one month
AIPE
Arabic index of premature ejaculation
Measured: Change from baseline after one month
Secondary outcomes (1)
IELT
Intra-vaginal Ejaculation Latency Time
Measured: Change from baseline after three, six and nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start19 Aug 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Wael Ragab, Cairo University
- Investigators
- Hamed A Hamed, MD, Study director, Professor of Andrology, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459833
- Sponsor's protocol ID
- PE:HA glans augmentation
- Status last verified
- Mar 2018
- First submitted
- 12 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT03459833
- Acronym / sponsor ID
- PE:HA glans augmentation
- Conditions
- Premature Ejaculation
- Keywords
- premature ejaculation, IELT, hyaluronic acid, glans penis augmentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Aug 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- 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.
This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Hyaluronic Acid15 patients They will receive a topical anesthetic agent for 30 minutes (Emla cream; lidocaine 25 mg, prilocaine 25 mg, Astra Xeneca, Mississauga, Canada) followed by injection of two prefilled 1 ml syringes with 30 G needle of hyaluronic acid (HA; Teosyal® PureSense Global Action, Teoxane Laboratories, Geneva, Switzerland). After 18 months from the HA injection, cross-over to placebo arm will be done. |
| group 2 | Placebo comparator | Drug: Hyaluronic AcidThey receive by the same method 2 ml saline as a placebo. After one month of the injection, cross-over to HA arm will be done. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- occurrence of ejaculation in patients with lifelong premature ejaculation (LL PE) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (A PE), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy
Key exclusion criteria (6 listed)
- Erectile dysfunction
- Hypo or hyperthyroidism
- Hypogonadism
- Hyperprolactinemia
- Drug abuse
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 |
|---|---|---|
| Hyaluronic AcidGlans penis augmentation using multiple puncture technique as described by Abdallah et al. (2012) with minor modifications. HA is injected at two circular levels: one at the level of corona of glans penis and a second circular level is mid-way between the corona and urethral meatus. Six injections are injected at coronal level and four are injected in the second level, each injection is of 0.2 ml and is injected into deep dermis. | Drug | group 1, group 2 |
Primary outcome
IELT
Time frame: Change from baseline after one month
Intra-vaginal Ejaculation Latency Time
AIPE
Time frame: Change from baseline after one month
Arabic index of premature ejaculation
1 secondary outcome
IELT
Time frame: Change from baseline after three, six and nine months
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 13 Mar 2018.
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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.
Hamed A Hamed, MD study director
Professor of Andrology, Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyaluronic Acid in people with Premature Ejaculation, run by Cairo University.
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 1 inclusion and 6 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 13 Mar 2018. 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. 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 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?
IELT (time frame: Change from baseline after one month). The study lists 2 primary outcomes in all. 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 13 Mar 2018.