Therapeutic Outcomes of Selective Serotonin Reuptake Inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy Versus Monotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorSouth Valley University

About this trial

Premature ejaculation (PE) is a prevalent male sexual dysfunction that affects as many as 20-30% of men regardless of age and ethnicity.The International Society for Sexual Medicine defines premature ejaculation as a male sexual dysfunction characterised by ejaculation that always or nearly always occurs before or within about 1 minute of vaginal penetration from the first sexual experience (lifelong premature ejaculation) or a clinically significant and bothersome reduction in latency time, often to about 3 minutes or less (acquired premature ejaculation), the inability to delay ejaculation on all or nearly all vaginal penetrations and with negative personal consequences include distress, bother, frustration, and avoidance of sexual intimacy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with PE: Men aged 18-60 years with a diagnosis of PE according to the International Society for Sexual Medicine (ISSM) criteria.

Healthy controls: Men aged 18-60 years without a history of PE or other sexual dysfunctions.

Disqualifiers

Other sexual dysfunctions: Erectile dysfunction, delayed ejaculation, or other sexual disorders.

Cardiovascular disease: history of cardiovascular disease, hypertension, or stroke.

Neurological or psychiatric disorders: Conditions that may affect sexual function, such as depression, anxiety, or Parkinson's disease.

Medications affecting sexual function: Current use of medications that may impact sexual function, such as antidepressants or antipsychotics.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paroxetine 20 Mg Oral Tablet

    Drug

    to compare the safety and efficacy of paroxetine alone versus the combination of paroxetine and sildenafil in Premature Ejaculation Patients with genetic polymorphism in the serotonin transporter gene-linked polymorphic region.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group A (Drug Comination Therapy)Active comparator 1 intervention
Group B: Group B (Monotherapy)Active comparator 1 intervention
Group C: Group C (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment of premature ejaculation

Treating the patients whom having Premature Ejaculation with selective serotonin reuptake inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy with genetic polymorphism in the serotonin transporter gene-linked polymorphic region.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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