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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-30

Study Completion Date

2022-12-25

Brief Summary

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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

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Detailed Description

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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 .

Conditions

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Premature Ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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Sildenafil 50 mg

PD5I

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Tramadol Hydrochloride 100 MG

opiod

Intervention Type DRUG

Other Intervention Names

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sildanafil no drug tamol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes