Premature ejaculation Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Side effects will be recorded and reported throughout the treatment period. | — |
Countries
Türkiye