premature ejaculation. Premature ejaculation
Conditions
Interventions
Intervention 1: Intervention Group 1: Patients in this group will receive an oral tablet of dapoxetine 30 mg (containing 30 mg of the active ingredient dapoxetine hydrochloride) along with a placebo c
Sponsors
Ghoum University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Primary or Secondary Premature Ejaculation (PEDT Score = 11) A minimum of 6 months since the initiation of sexual activity The patient should have sexual intercourse at least once a week married
Exclusion criteria
Exclusion criteria: diagnosis of erectile dysfunction Diagnosis of other sexual dysfunctions Presence of sexual dysfunction in the patient's partner Diagnosis of major psychiatric disorders Diagnosis of diabetes mellitus Presence of neurological disorders Receipt of any other treatments for premature ejaculation within the past 3 months Advanced renal, hepatic, or hematological diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Intravaginal Ejaculatory Latency Time - IELT: The mean IELT measured at week 4 after the start of treatment minus the mean IELT measured at baseline (before treatment). This change will be calculated for each of the three groups (dapoxetine, pregabalin, and placebo) and then compared with each other. Timepoint: The intravaginal ejaculatory latency time (IELT) will be measured at baseline (before the intervention) and during the 4 weeks following drug administration. Method of measurement: ELT is measured with a stopwatch by the patient himself during sexual intercourse. To determine the baseline IELT, the average time of 4 intercourses prior to treatment is calculated. To determine the post-treatment IELT, the average of the times measured during the 4-week treatment period is calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events: Any untoward or undesirable medical occurrence in a participant that is temporally associated with the use of the investigational drug (Dapoxetine, Pregabalin, or placebo), regardless of whether it is definitively attributed to the drug. Timepoint: During the 4-week treatment period: The primary assessment will be conducted throughout the 4-week drug administration period. Patients will be instructed to report any adverse events to the researcher in the intervals between visits as well. Method of measurement: his variable is measured qualitatively using patient self-reporting combined with active inquiry by the researcher. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArmin Ababaf Shooshtari
Ghoum University of Medical Sciences
Outcome results
None listed