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Efficacy and safety of daily paroxetine 20 mg and on-demand lidocaine spray combination in the treatment of premature ejaculation

Dual approach to ejaculatory control: daily paroxetine and on-demand lidocaine spray for treating premature ejaculation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN31283266
Enrollment
83
Registered
2025-07-25
Start date
2024-07-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature ejaculation Urological and Genital Diseases

Interventions

After obtaining detailed medical and sexual history of the patients, a physical examination was performed. Intravaginal ejaculation delay times (IELT) were recorded to clarify the PE diagnosis of the

Sponsors

Memorial Hospital Institutional Review Board
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Men aged 18-65 years 2. Those who have had a heterosexual relationship with a single partner for more than 6 months at the time of enrollment and will continue this relationship throughout the study 3. Patients with a clinical diagnosis of erectile dysfunction and an IIEF score of >21 4. Those with a premature ejaculation score of =11 5. Patients and their partners agreeing to have sexual intercourse two times per week during the study period 6. Patients who commit to comply with the study protocol 7. Patients who sign an informed consent form 8. Patients who describe lifelong and acquired PE according to the definition of the International Society for Sexual Medicine (ISSM)

Exclusion criteria

Exclusion criteria: 1. Those with a history of urological surgery, anatomic abnormality, or neurological disorders (e.g., multiple sclerosis), trauma or infection that may be associated with the development of premature ejaculation symptoms and is thought to be a potential cause of premature ejaculation 2. Those with a genital anomaly other than penile curvature that does not prevent sexual intercourse 3. Those who develop ED or PE due to drug withdrawal or drug use 4. Those whose spouses have any problems with sexual intercourse 5. Those with a history of severe psychiatric illness or suicide attempt 6. Those with a history of epilepsy 7. Those with a history of stroke, myocardial infarction, heart failure, unstable angina, life-threatening arrhythmia, or hypotension in the last 6 months 8. Those who are not suitable for sexual intercourse due to existing health problems 9. Those with resting systolic/diastolic blood pressure <90/50 mmHg and <170/100 mmHg 10. Those with a history of allergy to SSRIs and lidocaine-containing drugs 11. Continuing to use or discontinuing within the last 14 days, drugs such as monoamine oxidase inhibitors (MAOI), thioridazine, selective serotonin reuptake inhibitors (SSRIs), selective-norepinephrine reuptake inhibitors (SNRIs), serotonergic drugs/herbal products, tricyclic antidepressants, and atypical antipsychotics 12. Nitrates, alpha blockers, vasodilators, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, cimetidine, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem, any vasodilator, antiplatelet, anticoagulant, dapoxetine, PDE5 inhibitors, alcohol, and stimulant drug users 13. Alcohol and drug addicts 14. Patients with premature ejaculation diagnosis receiving other forms of therapy (behavioral therapy or other locally applied medications) 15. Those who may receive medication that may affect the pharmacokinetic/pharmacodynamic properties of the study drugs during the study period 16. Patients with clinically defined symptoms of prostatitis 17. Those with thyroid hormone disorders

Design outcomes

Primary

MeasureTime frame
Before and after treatment: 1. Intravaginal ejaculation latency time (IELT) will be assessed in seconds as an estimated outcome. 2. Premature Ejaculation Profile: This is a questionnaire consisting of four questions.

Secondary

MeasureTime frame
Side effects will be recorded and reported throughout the treatment period.

Countries

Türkiye

Contacts

Public ContactIlker Comez
info@drilkercomez.com+90 (0)532 592 20 54

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026