A Phase 3 interventional study of Hyaluronic Acid in Premature Ejaculation, sponsored by Cairo University. Completed. Open to male participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-13.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
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 .
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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.
Drug: Hyaluronic Acid
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.
Drug: Hyaluronic 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.
IELT
Intra-vaginal Ejaculation Latency Time
Time frame: Change from baseline after one month
AIPE
Arabic index of premature ejaculation
Time frame: Change from baseline after one month
IELT
Intra-vaginal Ejaculation Latency Time
Time frame: Change from baseline after three, six and nine months
No study locations are listed for this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid