Clinical trial
Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature: A Randomized Controlled Trial
Name
20240130002
Description
The aim of this study was to compare the effectiveness and safety of selective serotonin reuptake inhibitors (dapoxetine) and hyaluronic acid gel injection in the glans penis for lifelong premature.
Trial arms
Trial start
2022-10-01
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Completed
Treatment
Selective serotonin re-uptake inhibitor
Patients recieved selective serotonin re-uptake inhibitor as medical treatment for treatment of premature ejaculate.
Arms:
Selective serotonin re-uptake inhibitor
Hyaluronic acid
Patients recieved injection of glans penis with hyaluronic acid
Arms:
Hyaluronic acid
Size
60
Primary endpoint
Intravaginal ejaculation latency time (IELT)
6 months following treatment
Eligibility criteria
Inclusion Criteria:
* Age ≥ 18 years old.
* Males.
* Suffering from lifelong premature ejaculation not responding to the behavioral therapy.
Exclusion Criteria:
* Erectile dysfunction.
* Prostatitis.
* Acquired premature ejaculation.
* Addiction.
* Psychiatric disorders (e.g., schizophrenia, bipolar disorder, and other psychoses).
* Historical use of ejaculatory medication within the previous three months.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-06-11
1 organization
2 products
4 indications
Organization
New Valley UniversityIndication
SSRIIndication
Hyaluronic AcidIndication
Penis glansIndication
Premature BirthProduct
Hyaluronic acid