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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 .
Age
18 - 50 years
Sex
MALE
Healthy Volunteers
Yes
Start Date
December 30, 2021
Primary Completion Date
December 25, 2022
Completion Date
December 25, 2022
Last Updated
January 10, 2022
160
ESTIMATED participants
Sildenafil 50 mg
DRUG
Placebo
DRUG
Tramadol Hydrochloride 100 MG
DRUG
Lead Sponsor
Assiut University
NCT07434271
NCT06570135
Data Source & Attribution
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