Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

Assiut University

Status and phase: Unknown; Phase 3

Conditions: Premature Ejaculation

Treatments: Other: placebo; Drug: Tamsulosin; Drug: Paroxetine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03879746

premature ejaculation

Details and patient eligibility

About

A study to compare the effect of tamsulosin versus the effect of paroxetine hydrochloride and the effect of combination of them on PE.

Full description

Premature ejaculation is considered the most common male sexual disorder. affecting approximately 4-39 % of men in general community. In 2008, the International Society for Sexual Medicine defined premature ejaculation as a male sexual dysfunction that is characterized by ejaculation that always or nearly always occurs within or before 1 minute of vaginal penetration. Moreover it is associated with presence of distress, frustration, bother, negative personal consequences, depression and the avoidance of sexual intimacy.

Many etiological theories have been included in the pathogenesis of premature ejaculation: neurobiological, psychological, environmental and endocrine factors. So a lot of therapeutic modalities, such as behavioral therapy, selective serotonin reuptake inhibitors (SSRIs), adrenergic alpha 1 antagonists, local anesthetic creams, clomipramine, phosphodiesterase type 5 inhibitors and centrally acting analgesics have been used for the treatment of premature ejaculation.

Previous studies reported that tamsulosin which is alpha blocker agent used as primary therapeutic agent for BPH is effective in the improvement of sexual function. However studies on the effect of tamsulosin on ejaculation reported that tamsulosin had inhibitory effect in the emission phase of ejaculation including decreased ejaculatory volume. So inhibitory effect of tamsulosin on ejaculation may be beneficial to patients suffering from premature ejaculation.

Historically, PE was considered psychological problem and was treated by behavioral treatment and psychotherapy but there is pharmacological studies increase the evidence that PE may be related to decreased serotonergic neurotransmission. So selective serotonin reuptake inhibitors (SSRIs ) such as : paroxetine, fluoxetine, dapoxetine, and sertraline are among the recommended pharmacological treatments for treating PE. But there is no universal agreement on the type, the dose and administration protocol.

So a study is needed to compare the value of combination therapy of both tamsulosin and paroxetine with the value of single therapy of either of them and consider Intravaginal Ejaculatory Latency Time (IELT) and ejaculatory control ability of patients after using tamsulosin and paroxetine.

Enrollment: 160 estimated patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Married, sexually active patients with PE will be included with ages ranging from 20 to 60 years.

Exclusion criteria

• Patients suffering from erectile dysfunction, DM, HTN, neurological disorders and psychological disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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160 participants in 4 patient groups, including a placebo group

tamsulosin group

Active Comparator group

Description:

the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg

Treatment:

Drug: Tamsulosin

paroxetine group

Active Comparator group

Description:

the second group will include 40 patients treated with daily administration of paroxetine 20 mg

Treatment:

Drug: Paroxetine Hydrochloride

combined group

Active Comparator group

Description:

the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg

Treatment:

Drug: Paroxetine Hydrochloride

Drug: Tamsulosin

placrbo group

Placebo Comparator group

Description:

the fourth group will include 40 patients will be given placebo

Treatment:

Other: placebo