An interventional study of Paroxetine 20 Mg Oral Tablet in Premature Ejaculation, sponsored by South Valley University. Not yet recruiting at 1 site in Egypt. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by South Valley University · Not applicable, Interventional, and Treatment
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.
Oral intake of tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRI) has emerged as effective for patients with PE whether or not these patients suffered from depression. Sildenafil, a phosphodiesterase-5 inhibitor (PDE5i), was tried for premature ejaculation, and in one study associated with paroxetine (a SSRI), with IELT (intravaginal ejaculation latency time) going from 0.35 to 4.5 min.
Serotonin (5-hydroxytryptamine, 5-HT) plays an important role at the level of the central nervous system in the complex regulatory mechanisms involved in ejaculation. In clinical practice, selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g., paroxetine, fluoxetine and sertraline) and the tricyclic antidepressant clomipramine are widely used to treat lifelong PE, suggesting that 5-HT and SSRIs play roles in the pathophysiology and treatment of PE. In this group, paroxetine and sertraline are often used effectively to treat PE, although none of these agents have been officially recognized as treatments for this condition.
SSRIs increase synaptic 5-HT concentrations in the ejaculation-related areas of the central nervous system by blocking 5-HT transporters. The serotonin transporter (5-HTT) plays an important role in the clearance of synaptic 5-HT, thereby regulating presynaptic and postsynaptic 5-HT receptor stimulation. Human 5-HTT is encoded by a single gene (SLC6A4) on chromosome 17q12. A polymorphism in the transcribed region can be caused by a 44-bp insertion ('long allele' [L]) or deletion ('short allele' [S]).
The transcriptional activity of the L allele has been reported to be twice as high as the S allele. Theoretically, men with one or more S alleles for the 5-HTT have fewer functioning transporters and could therefore lead to a higher serotonergic neurotransmission. Consequently, it is postulated that men with SS genotype have longer IELT durations than men with LL genotype.In the literature, a variety of findings have been reported concerning the relationship between 5-HTT polymorphism and the SSRI response.
Exclusion Criteria:
Twenty patients with premature ejaculation , matching inclusion \& exclusion criteria as mentioned before, will receive SSRI (paroxetine 20mg/day) + PDE5 inhibitor (sildenafil 25mg/day) for 3 months . Follow up clinically every 4 weeks for 12 weeks.
Drug: Paroxetine 20 Mg Oral Tablet
Twenty patients with premature ejaculation will receive SSRI (paroxetine 20mg/day) + placebo for 3 months . Follow up clinically every 4 weeks for 12 weeks.
Drug: Paroxetine 20 Mg Oral Tablet
Twenty healthy matched individuals will receive placebo + placebo for 3 months . Follow up clinically every 4 weeks for 12 weeks.
Drug: Paroxetine 20 Mg Oral Tablet
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.
Also known as: sildenafil 25mg Oral Tablet, Placebo
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
South Valley University