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

Primary Purpose

Premature Ejaculation

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sildenafil 50 mg
Placebo
Tramadol Hydrochloride 100 MG
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    group 1

    group2

    group 3

    group 4

    Arm Description

    patients with PE

    patients with PE

    patients with PE

    patients with PE

    Outcomes

    Primary Outcome Measures

    satisfaction score
    sore of sexual satisfaction

    Secondary Outcome Measures

    Full Information

    First Posted
    December 21, 2021
    Last Updated
    December 21, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05183334
    Brief Title
    Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation
    Official Title
    Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation: A Randomized Placebo-controlled Double-blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 30, 2021 (Anticipated)
    Primary Completion Date
    December 25, 2022 (Anticipated)
    Study Completion Date
    December 25, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ejaculation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1
    Arm Type
    Placebo Comparator
    Arm Description
    patients with PE
    Arm Title
    group2
    Arm Type
    Experimental
    Arm Description
    patients with PE
    Arm Title
    group 3
    Arm Type
    Experimental
    Arm Description
    patients with PE
    Arm Title
    group 4
    Arm Type
    Experimental
    Arm Description
    patients with PE
    Intervention Type
    Drug
    Intervention Name(s)
    Sildenafil 50 mg
    Other Intervention Name(s)
    sildanafil
    Intervention Description
    PD5I
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    no drug
    Intervention Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol Hydrochloride 100 MG
    Other Intervention Name(s)
    tamol
    Intervention Description
    opiod
    Primary Outcome Measure Information:
    Title
    satisfaction score
    Description
    sore of sexual satisfaction
    Time Frame
    8week

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    male act
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed reda, MD
    Phone
    01061133200
    Email
    ahmedreda_leo@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mostafa kamel, DR
    Phone
    01061133200
    Email
    mostafa075@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ahmed reda, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    14723556
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28497478
    Citation
    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.
    Results Reference
    background

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

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