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

NCT05183334 | Unknown Phase 4

• 1 other identifier: sildenafil and tramadol in PE
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• satisfaction score

  sore of sexual satisfaction

  8week

Study Arms (4)

group 1

PLACEBO COMPARATOR

patients with PE

Drug: Placebo

group2

EXPERIMENTAL

patients with PE

Drug: Sildenafil 50 mg

group 3

EXPERIMENTAL

patients with PE

Drug: Tramadol Hydrochloride 100 MG

group 4

EXPERIMENTAL

patients with PE

Drug: Sildenafil 50 mg; Drug: Tramadol Hydrochloride 100 MG

Interventions

Sildenafil 50 mg DRUG

PD5I

Also known as: sildanafil

group 4; group2

Placebo DRUG

placebo

Also known as: no drug

group 1

Tramadol Hydrochloride 100 MG DRUG

opiod

Also known as: tamol

group 3; group 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: male act
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 14723556 BACKGROUND

• 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.

  PMID: 28497478 BACKGROUND

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Sildenafil Citrate; Tramadol; tamol

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• ahmed reda, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed reda, MD

CONTACT

01061133200; ahmedreda_leo@yahoo.com

mostafa kamel, DR

CONTACT

01061133200; mostafa075@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: December 30, 2021
• Primary Completion: December 25, 2022
• Study Completion: December 25, 2022
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share