- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459833
Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation
March 10, 2018 updated by: Mohamed Wael Ragab, Cairo University
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 .
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Erectile dysfunction
- Hypo or hyperthyroidism
- Hypogonadism
- Hyperprolactinemia
- Drug abuse
- Psychiatric disorders or related medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group 1
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.
|
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.
|
Placebo Comparator: group 2
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IELT
Time Frame: Change from baseline after one month
|
Intra-vaginal Ejaculation Latency Time
|
Change from baseline after one month
|
AIPE
Time Frame: Change from baseline after one month
|
Arabic index of premature ejaculation
|
Change from baseline after one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IELT
Time Frame: Change from baseline after three, six and nine months
|
Intra-vaginal Ejaculation Latency Time
|
Change from baseline after three, six and nine months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hamed A Hamed, MD, Professor of Andrology, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
February 12, 2018
First Submitted That Met QC Criteria
March 3, 2018
First Posted (Actual)
March 9, 2018
Study Record Updates
Last Update Posted (Actual)
March 13, 2018
Last Update Submitted That Met QC Criteria
March 10, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pregnancy Complications
- Obstetric Labor Complications
- Sexual Dysfunctions, Psychological
- Obstetric Labor, Premature
- Sexual Dysfunction, Physiological
- Premature Birth
- Premature Ejaculation
- Physiological Effects of Drugs
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Viscosupplements
- Hyaluronic Acid
Other Study ID Numbers
- PE:HA glans augmentation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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