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
About this trial
This is an interventional treatment trial for Premature Ejaculation
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.
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
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
Learn more about this trial
Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation
We'll reach out to this number within 24 hrs