Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation

Overview

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

Full Title of Study: “Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation: A Randomized Placebo-controlled Double-blind Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 25, 2022

Detailed Description

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 ยต-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 .

Interventions

  • Drug: Sildenafil 50 mg
    • PD5I
  • Drug: Placebo
    • placebo
  • Drug: Tramadol Hydrochloride 100 MG
    • opiod

Arms, Groups and Cohorts

  • Placebo Comparator: group 1
    • patients with PE
  • Experimental: group2
    • patients with PE
  • Experimental: group 3
    • patients with PE
  • Experimental: group 4
    • patients with PE

Clinical Trial Outcome Measures

Primary Measures

  • satisfaction score
    • Time Frame: 8week
    • sore of sexual satisfaction

Participating in This Clinical Trial

Inclusion Criteria

  • no previous medical treatment for PE – history of premature ejaculation (PE), primary or secondary, and a maximum IELT of 2 minutes prior to treatment. Exclusion Criteria:

  • drug noncompliance, positive history of diabetes mellitus, psychological problems, neurological disorders, erectile dysfunction, chronic illnesses, interpersonal troubles with the spouse, as well as long term medications that could affect the patient condition.

Gender Eligibility: Male

male act

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mostafa Kamel Abdel Rahman, DR – Assiut University
  • Overall Official(s)
    • ahmed reda, MD, Principal Investigator, Assiut University
  • Overall Contact(s)
    • ahmed reda, MD, 01061133200, ahmedreda_leo@yahoo.com

References

Abdel-Hamid IA. Phosphodiesterase 5 inhibitors in rapid ejaculation: potential use and possible mechanisms of action. Drugs. 2004;64(1):13-26. doi: 10.2165/00003495-200464010-00002.

Abu El-Hamd M, Abdelhamed A. Comparison of the clinical efficacy and safety of the on-demand use of paroxetine, dapoxetine, sildenafil and combined dapoxetine with sildenafil in treatment of patients with premature ejaculation: A randomised placebo-controlled clinical trial. Andrologia. 2018 Feb;50(1). doi: 10.1111/and.12829. Epub 2017 May 12.

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