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

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Premature Ejaculation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05183334

sildenafil and tramadol in PE

Details and patient eligibility

About

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

Full 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 .

Enrollment: 160 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 4 patient groups, including a placebo group

group 1

Placebo Comparator group

Description:

patients with PE

Treatment:

Drug: Placebo

group2

Experimental group

Description:

patients with PE

Treatment:

Drug: Sildenafil 50 mg

group 3

Experimental group

Description:

patients with PE

Treatment:

Drug: Tramadol Hydrochloride 100 MG

group 4

Experimental group

Description:

patients with PE

Treatment:

Drug: Sildenafil 50 mg

Drug: Tramadol Hydrochloride 100 MG