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

NCT07057011 | Not Yet Recruiting DMC

• 1 other identifier: ٍSerotonin Reuptake Inhibitors
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ejaculation

Outcome Measures

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.

  3 months

Study Arms (3)

Group A (Drug Comination Therapy)

ACTIVE COMPARATOR

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

Group B (Monotherapy)

ACTIVE COMPARATOR

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

Group C (Control)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: sildenafil 25mg Oral Tablet, Placebo

Group A (Drug Comination Therapy); Group B (Monotherapy); Group C (Control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University Hospital

Qina, Egypt

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Paroxetine; Tablets; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mostafa Adam Ali El-Taib, Professor

  Dermatology, venereology and andrology ,Qena Faculty of medicine ,south valley university.

  STUDY CHAIR

• Ebtehal Alaa El-Din Kotop Mohamed, Lecturer

  Dermatology, venereology and andrology ,Qena Faculty of medicine ,south valley university.

  STUDY DIRECTOR

Central Study Contacts

Mohamed Ahmed Mohamed Mousaa, MSC

CONTACT

+201061574354; drmohamedelmurshedy@gmail.com

Mohammed Hosny Hassan., professor

CONTACT

+201098473605; mohammedhosnyhassaan@med.svu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Dermatology , venereology and andrology, Faculty of medicine

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 10, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)