Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03459833

Enrollment

Registered

2018-03-09

Start date

2016-08-19

Completion date

2018-03-31

Last updated

2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

Keywords

premature ejaculation, IELT, hyaluronic acid, glans penis augmentation

Brief 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 .

Interventions

DRUGHyaluronic Acid

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 design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015

Eligibility

Sex/Gender

MALE

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
IELT	Change from baseline after one month	Intra-vaginal Ejaculation Latency Time
AIPE	Change from baseline after one month	Arabic index of premature ejaculation

Secondary

Measure	Time frame	Description
IELT	Change from baseline after three, six and nine months	Intra-vaginal Ejaculation Latency Time

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026