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

Phase 4

• Conditions: Premature Ejaculation
• Interventions: Drug: Sildenafil 50 mg; Drug: Placebo; Drug: Tramadol Hydrochloride 100 MG

• Registration Number: NCT05183334
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Study Start: 2021-12-30
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-12-25
• Study Completion: 2022-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group2	Sildenafil 50 mg	patients with PE
group 1	Placebo	patients with PE
group 4	Sildenafil 50 mg	patients with PE
group 3	Tramadol Hydrochloride 100 MG	patients with PE
group 4	Tramadol Hydrochloride 100 MG	patients with PE

Primary Outcome Measures

Name	Time	Method
satisfaction score	8week	sore of sexual satisfaction