Premature Ejaculation Clinical Trial
Official title:
Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation: A Randomized Placebo-controlled Double-blind Clinical Trial
Premature Ejaculation (PE) is a common sexual dysfunction that has a negative impact on both sex partners. Several lines of treatment have been proposed for the treatment of PE i.e. psychological, behavioral, physiotherapeutic, and pharmacological therapies.Several treatment options have been proposed for treatment of PE including tramadol HCl and PDE5 inhibitors Tramadol HCl is thought to exert its therapeutic action in PE patients
It's clear that PE poses much burden not only on the patient sexual life but also on all aspects of the life of both the patient and his partner. Several treatment options have been proposed for treatment of PE including tramadol HCl and PDE5 inhibitors . Tramadol HCl is thought to exert its therapeutic action in PE patients through one or more of the following mechanisms: weak µ-opioid effect, 5-HT2 receptor antagonist effect, N-methyl-D-aspartate receptor antagonist effect, serotonin and norepinephrine reuptake inhibitory effect , and acetylcholine receptor antagonist effect . On the other hand, PDE5 inhibitors are thought to play a therapeutic role in treating PE though the following mechanisms: peripheral delay of ejaculation through modulation of contractions of the vas deferens, seminal vesicles, prostate and urethra, increasing the duration of erection , central decrease of the sympathetic output via modulation of NO activity in the medial pre-optic area , peripheral analgesic effect, peripheral analgesic effect, increasing patient confidence, and improving the perception of ejaculation control and sexual satisfaction . ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02232425 -
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
|
Phase 2 | |
| Completed |
NCT01439984 -
Trial of PED-1 in Male Patients With Premature Ejaculation
|
Phase 3 | |
| Completed |
NCT01184105 -
A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation
|
Phase 1 | |
| Completed |
NCT01203202 -
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
|
Phase 2 | |
| Completed |
NCT03942367 -
Evaluation of the Safety and Effectiveness of the vPatch Device
|
N/A | |
| Recruiting |
NCT06425211 -
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
|
N/A | |
| Completed |
NCT02939495 -
The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy
|
Phase 4 | |
| Completed |
NCT02572037 -
Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
|
||
| Recruiting |
NCT02581826 -
Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation
|
Phase 2 | |
| Terminated |
NCT00983736 -
Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation
|
Phase 3 | |
| Completed |
NCT00556478 -
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
|
Phase 2/Phase 3 | |
| Completed |
NCT00549211 -
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
|
Phase 1 | |
| Not yet recruiting |
NCT05556083 -
Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
|
Phase 2 | |
| Completed |
NCT03304808 -
Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0
|
N/A | |
| Completed |
NCT00861484 -
Proof of Mechanism in ELT
|
Phase 1 | |
| Completed |
NCT02984592 -
Effect of Exercise on Premature Ejaculation
|
N/A | |
| Recruiting |
NCT02571101 -
A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation
|
Phase 2 | |
| Completed |
NCT03174470 -
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
|
N/A | |
| Completed |
NCT02794454 -
A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health
|
N/A | |
| Completed |
NCT02297152 -
A New Treatment for Premature Ejaculation?
|
N/A |