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

Study Overview
=================
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 .

Official Title
-----------------
Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation: A Randomized Placebo-controlled Double-blind Clinical Trial

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: Sildenafil 50 mg
* Drug: Placebo
* Drug: Tramadol Hydrochloride 100 MG


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group 1<br>patients with PE | Drug: Placebo<br>* placebo<br>* Other names: no drug;|
| Experimental: group2<br>patients with PE | Drug: Sildenafil 50 mg<br>* PD5I<br>* Other names: sildanafil;|
| Experimental: group 3<br>patients with PE | Drug: Tramadol Hydrochloride 100 MG<br>* opiod<br>* Other names: tamol;|
| Experimental: group 4<br>patients with PE | Drug: Sildenafil 50 mg<br>* PD5I<br>* Other names: sildanafil;Drug: Tramadol Hydrochloride 100 MG<br>* opiod<br>* Other names: tamol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction score | sore of sexual satisfaction | 8week |