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All four treatment groups demonstrated significant within-group improvements in IELT from baseline (p < 0.001 for all).

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A prospective randomized trial was conducted from June 2024 to March 2025 at Beni-Suef University Hospital. Four hundred eligible patients diagnosed with lifelong PE were randomly allocated to one of four active treatment groups (n = 100 per group): (1) citalopram 20 mg/day, (2) silodosin 4 mg/day, (3) dapoxetine 30 mg on-demand (1–3 h before intercourse), or (4) dapoxetine 30 mg daily. The primary outcome was the change in intravaginal ejaculatory latency time (IELT) measured by stopwatch. Secondary outcomes included changes in the Premature Ejaculation Profile Questionnaire (PEPQ) scores and the incidence of treatment-emergent adverse events. Statistical analysis was performed using ANOVA with post-hoc tests for continuous variables and chi-square tests for categorical data. The citalopram group exhibited the greatest mean IELT increase (from 110.4 ± 31.5s to 391.2 ± 45.9s; 260% median gain), outperforming the daily dapoxetine (220%), on-demand dapoxetine (197%), and silodosin (149.5%) groups. Improvements in PEPQ scores mirrored the IELT findings, with citalopram showing a 300% improvement compared to 225%, 166.7%, and 175% in the daily dapoxetine, on-demand dapoxetine, and silodosin groups, respectively. Adverse event profiles differed: silodosin was associated with a higher incidence of ejaculatory dysfunction (23% retrograde ejaculation), while daily dapoxetine led to more systemic effects (18% dizziness). In this direct head-to-head comparison of active treatments for lifelong PE, daily citalopram (20 mg) demonstrated superior efficacy in prolonging IELT and improving psychosocial outcomes compared to daily or on-demand dapoxetine and silodosin. The findings suggest that citalopram is a highly effective first-line option, while the dose-dependent efficacy of dapoxetine and the distinct side-effect profile of silodosin provide alternative considerations for personalized treatment strategies. This clinical trial was registered at ClinicalTrials.gov (Identifier NCT07113145) on 7 August 2025 after the enrollment of the first participant and is therefore retrospectively registered.” Premature ejaculation (PE) is a common male sexual complaint, with an estimated global prevalence of 20–30% [1,2,3]. Although diagnostic criteria vary, approximately 1–3% of men experience severe forms characterized by an intravaginal ejaculatory latency time (IELT) of one minute or less [4]. PE is associated with significant psychological distress, reduced sexual satisfaction, impaired self-confidence, and a negative impact on the quality of life of both patients and their partners [5]. Over the years, treatment strategies for PE have evolved from behavioral and topical interventions to pharmacological approaches, primarily involving selective serotonin reuptake inhibitors (SSRIs) [6].

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Dapoxetine was created as an antidepressant but it differs from other SSRIs, in that it is absorbed and eliminated rapidly in the body. Its key advantage is the fast-acting property, which makes it ideally suited for the treatment of PE but not as an antidepressant. Dapoxetine is sold under the brand name Priligy amongst others. The USA-based Furiex Pharmaceuticals reached an agreement with ALZA Corp and Janssen Pharmaceutica in May 2012 to market Dapoxetine in the USA, Japan and Canada, while Menarini bought the selling the rights to market in Europe, Africa, Latin America and Middle East. However, later it was sold to Johnson & Johnson in 2003 and submitted a new drug application to the FDA for the treatment of premature ejaculation in 2004. Initially developed for depression, SSRIs such as citalopram were repurposed for PE after clinical observations revealed their ejaculatory delay as a side effect [7]. Randomized trials demonstrated that daily citalopram significantly prolonged IELT and improved patient satisfaction and ejaculatory control [8]. To address the need for on-demand therapy, dapoxetine, a short-acting SSRI, was specifically developed and became the first drug approved for PE in several countries. Clinical trials confirmed its efficacy in significantly increasing IELT and improving sexual satisfaction when taken before intercourse.

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Ejaculation is caused by the sympathetic nervous system. Originating in the ejaculatory pathway, this spinal reflex centre is mediated by the brain stem. This is influenced initially by nuclei in the brain called medial preoptic and paraventricular nuclei. Dapoxetine inhibits the neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre- and postsynaptic receptors. The best way to find and gain access to Dapoxetine manufacturers and Dapoxetine suppliers is through Pipelinepharma's global B2B online marketplace for medicines and other pharmaceuticals. While daily SSRIs demonstrated efficacy in PE treatment, their requirement for continuous administration and delayed onset (2–3 weeks) created demand for an on-demand alternative [9].

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The doctors will conduct an appraisal of individual benefit-risk after the first four weeks or 6 doses of treatment. In the USA, the consumers have to pay around USD09 for a supply of 1mL for injection. Where the supply of 25mg tablets costs USD 70, 50mg cost USD 120 and the price of 100mg is USD 210 for a month’s supply. In India, the prices are significantly lower at 6 tablets of 30mg costing as low as USD 2. Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI), much higher than its major human metabolites, desmethyldapoxetine and didesmethyldapoxetine. Another agent, silodosin, a selective α1A-adrenoceptor antagonist originally approved for lower urinary tract symptoms, emerged as a potential PE therapy due to its common side effect of ejaculatory dysfunction. Early studies demonstrated that silodosin could substantially prolong IELT in men with PE, making it a promising off-label option [10, 11]. Given the fact that there was no previous study addressing the comparison of the three drugs together and the limitations with varying mechanisms of existing therapies, this randomized clinical trial was designed to evaluate and compare the efficacy and safety of Citalopram, Silodosin 4 mg, Dapoxetine 30 mg (on demand), and Dapoxetine 30 mg (daily) in the treatment of PE. This randomized clinical study was conducted between June 2024 and March 2025.

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It is sold in several European and Asian countries and Mexico. In preventing Premature Ejaculation in Adult men aged 18 to 64 years, the recommended starting dose is 30 mg, taken as needed. Note that the drug should be taken approximately 1 to 3 hours before sexual activity. This medicine is not for continuous daily use and used only when sexual activity is anticipated. Do not take it more frequently than once a day. A total of 400 male patients diagnosed with PE were enrolled. The study protocol was approved by the Institutional Review Board (IRB) of the Faculty of Medicine, Beni-Suef University (Approval No. : FMBSUREC/07052024/Ahmed), and all participants provided written informed consent prior to enrollment. A priori power analysis was conducted using G*Power 3.1 to determine the appropriate sample size for detecting differences in IELT among the four treatment groups. Based on an ANOVA model accounting for four treatment groups and four covariates (age, baseline IELT, comorbidities, and medication adherence), we calculated the required sample size using a medium effect size (f = 0.25), α = 0.05, and 95% power.

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Normally, finding trusted manufacturers and supplies of specific drugs like Dapoxetine can be a time-consuming challenge, but with Pipelinepharma's simple search engine and network of proven partners, the whole process becomes a lot easier. All you need to do to get started is to make use of our integrated search engine and start looking for suppliers or manufacturers of Dapoxetine to work with. You can fine-tune your search results using various filters too, letting you search for Dapoxetine from specific countries. Premature ejaculation (PE) is a prevalent male sexual dysfunction with limited comparative data on pharmacological treatments. This randomized clinical trial aimed to evaluate the efficacy and safety of four active pharmacological interventions for lifelong PE. The numerator degrees of freedom (df = 7) comprised 3 df for between-group comparisons (4 groups − 1) plus 4 df for the covariates. With 400 total participants (100 per group), the denominator df was 392, yielding a noncentrality parameter (λ) of 25.00 and achieving the target power of 0.950. This approach ensured adequate power to detect clinically meaningful differences while controlling relevant covariates. The total sample size in the ANOVA/ANCOVA framework was determined using the noncentral F distribution according to the following relationship: The achieved power is then calculated as: Using f = 0.25, α = 0.05, and 95% power, with four treatment groups and four covariates, the required sample size was confirmed as 400 participants (100 per group). Diagnosis of PE according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) [12]. ◦ Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) ◦ Inability to delay ejaculation during all or nearly all vaginal penetrations ◦ Negative personal consequences (distress, frustration, avoidance of sexual intimacy) Premature Ejaculation Diagnostic Tool (PEDT) score ≥11. ◦ Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) ◦ Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) ◦ Inability to delay ejaculation during all or nearly all vaginal penetrations ◦ Inability to delay ejaculation during all or nearly all vaginal penetrations ◦ Negative personal consequences (distress, frustration, avoidance of sexual intimacy) ◦ Negative personal consequences (distress, frustration, avoidance of sexual intimacy) Premature Ejaculation Diagnostic Tool (PEDT) score ≥11.