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IELT was significantly increased in both the dapoxetine (from [0.87 ± 0.31] to [2.84 ± 0.68] min, P < 0.05) and the sertraline group (from [0.84 ± 0.28] to [2.71 ± 0.92] min, P < 0.05) after medication. Based on the CGIC scores in premature ejaculation, the rate of excellence or effectiveness was 36.5% in the dapoxetine and 37. 5% in the sertraline group, and the rate of improvement was 63.5% in the former and 71.9% in the latter. The incidence rates of dizziness, nausea, headache, and diarrhea were slightly higher (P > 0.05) while those of fatigue, somnolence, and dry mouth significantly higher (P < 0.05) in the sertraline than in the dapoxetine group.
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A comprehensive evaluation of available published data included analysis of published full-length papers that were identified with Medline and Cancerlit from January 1981 to January 2006. Official proceedings of internationally known scientific societies held in the same time period were also assessed.
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To investigate the efficacy of DA-8031, a novel compound for the treatment of premature ejaculation (PE), we performed in vivo pharmacological studies using 2 preclinical animal models, electrical stimulation of sensory branch of pudendal nerve (SBPdn) and para-chloroamphetamine (PCA)-induced ejaculation model.
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The aim of the study was to determine whether dapoxetine, a short-acting selective serotonin reuptake inhibitor, acts at the spinal or supraspinal level to inhibit the ejaculatory reflex.
A novel and practical asymmetric synthesis of dapoxetine hydrochloride by using the chiral auxiliary (S)-tert-butanesulfinamide was explored. The synthesis was concise, mild, and easy to perform. The overall yield and stereoselectivity were excellent.
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The National Institute for Health Research Health Technology Assessment programme.
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Human semen contains spermatozoa secreted by the testes and a mixture of components produced by the bulbo-urethral and Littre (paraurethral) glands, prostate, seminal vesicles, ampulla, and epididymis. Ejaculation is used as a synonym for the external ejection of semen, but it comprises two phases: emission and expulsion. As semen collects in the prostatic urethra, the rapid preorgasmic distension of the urethral bulb is pathognomonic of impeding orgasm, and the man experiences a sensation that ejaculation is inevitable (in women, emission is the only phase of orgasm). The semen is propelled along the penile urethra mainly by the bulbocavernosus muscle. With Kegel exercises, it is possible to train the perineal muscles. Immediately after the expulsion phase the male enters a refractory period, a recovery time during which further orgasm or ejaculation is physiologically impossible. Age affects the recovery time: as a man grows older, the refractory period increases. Sexual medicine experts consider premature ejaculation only in the case of vaginal intercourse, but vaginal orgasm has no scientific basis, so the duration of intercourse is not important for a woman's orgasm. The key to female orgasm are the female erectile organs; vaginal orgasm, G-spot, G-spot amplification, clitoral bulbs, clitoris-urethra-vaginal complex, internal clitoris and female ejaculation are terms without scientific basis. Female sexual dysfunctions are popular because they are based on something that does not exist, i.e. the vaginal orgasm. The physiology of ejaculation and orgasm is not impaired in premature ejaculation: it is not a disease, and non-coital sexual acts after male ejaculation can be used to produce orgasm in women. Teenagers and men can understand their sexual responses by masturbation and learn ejaculatory control with the stop-start method and the squeeze technique. Premature ejaculation must not be classified as a male sexual dysfunction. It has become the center of a multimillion dollar business: is premature ejaculation-and female sexual dysfunction-an illness constructed by sexual medicine experts under the influence of drug companies?
Men with normal IELT values who want to postpone ejaculation do not need "drugs for the treatment of PE" but "ejaculation delaying drugs." Pharmacological research of these ejaculation-delaying drugs ought to be investigated in men with normal IELT values, such as in men with subjective PE, variable PE, and in male volunteers.
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Unknown impurity associated with the degradation process of dapoxetine base was isolated. The structure elucidation of this new compound using accurate mass data, IR and NMR spectroscopy is presented herein. The unambiguous resonance assignment concluded to the formation of geometrical isomers of cinnamyloxynaphtalenes via Cope elimination of dapoxetin-N-oxide, the major oxidative and metabolic degradation product of dapoxetine. An efficient and simple synthetic approach has also been developed for the synthesis of dapoxetine-N-oxide for the first time and cinnamyloxynaphtalene in order to confirm the proposed degradation pathway and structures of the degradation products. It was observed that the main degradation product of dapoxetine base when exposed to air is 1-(2E)-cinnamyloxynaphthalene, while its Z isomer was also confirmed as a minor impurity.
Current and upcoming treatment options for premature ejaculation (PE) are of global clinical interest. In 2008, the International Society for Sexual Medicine published an evidence-based definition for PE. While there are no US Food and Drug Administration-approved therapies for PE, the American Urological Association 2004 guidelines state the serotonergic antidepressants paroxetine, sertraline, fluoxetine and clomipramine and the topical lidocaine-prilocaine cream are effective treatment options. However, there are limitations associated with their use, which may be overcome by PE-specific therapies currently in development. Two agents that are in advanced stages of clinical development include: (i) dapoxetine, an on-demand short-acting selective serotonin reuptake inhibitor, and (ii) PSD502, a metered-dose aerosol containing lidocaine and prilocaine, also for on-demand treatment. Another on-demand agent in development is tramadol, a weak opioid that is currently approved for treating pain. Coupled with efficient diagnosis, it is hoped that these newer agents will improve the quality of life for patients who suffer from PE.
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Data were analyzed from two randomized, double-blind, placebo-controlled, phase 3 clinical trials (International and Asia-Pacific) that evaluated efficacy and safety of dapoxetine (30 mg or 60 mg as needed [PRN]) in patients with PE. Men were ≥18 years, in a stable monogamous relationship for ≥6 months, met DSM-IV-TR criteria for PE for ≥6 months, had an International Index of Erectile Function EF domain score ≥21, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes.
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1E10, 101M; AAV-ASPA, agomelatine, aliskiren fumarate, alvimopan hydrate, ambrisentan, apaziquone, axitinib; Becatecarin, belagenpumatucel-L, BMS-201038; Cannabidiol, Cannabis sativa L. extract, capromorelin, CBP-501, cediranib, cetuximab, CHR-2797; Dapoxetine hydrochloride, degarelix acetate, desvenlafaxine succinate, dimethyl fumarate, dronedarone hydrochloride; Ecogramostim, eprodisate sodium; Falciparum merozoite protein-1/AS02A, fospropofol disodium; Gefitinib, glucarpidase, GTI-2040; Hepatitis C vaccine, HMR-4902, human proinsulin C-peptide, hyaluronic acid; Ipilimumab, ixabepilone; Lapatinib, lenalidomide, lestaurtinib, liposome encapsulated doxorubicin; Manidipine hydrochloride/delapril hydrochloride, metreleptin, MG-98, MGCD-0103, morphine glucuronide; Nebicapone; O6-benzylguanine, ofatumumab, olmesartan medoxomil/hydrochlorothiazide; PAN-811, pemetrexed disodium, perifosine, pertuzumab, Peru-15, pexelizumab, pirfenidone, pralatrexate, prasugrel; Quercetin; Rivaroxaban; Semaxanib, St. John's Wort extract; Ticagrelor, tomopenem, triplatin tetranitrate; Ulipristal acetate; Vandetanib, vatalanib succinate, vildagliptin; XK-469; ZT-1.
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Manufacturer-funded drug treatment research (categories A and B) is advantageously treated by some authors as compared with nonfunded trials with daily conventional SSRIs (category C). PE drug treatment research is a young and dynamic field, and its development deserves transparency to its development.
A health supplement used for sexual performance enhancement was sent to Health Sciences Authority of Singapore for testing. An unknown compound was detected and isolated and its structure was elucidated using NMR, high-resolution MS, ESI-MS/MS, UV and IR. The compound, dapoxetine, is reported to be a selective serotonin reuptake inhibitor under investigation for the treatment of premature ejaculation.
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The management recommendation for both acquired premature ejaculation (APE) and lifelong PE (LPE) are similar, such as a behavioral/psychotherapy, a pharmacotherapy and a combination of these treatments. For the drug treatment for PE, gold standard is selective serotonin reuptake inhibitors (SSRIs) including dapoxetine or paroxetine. The drug treatment for PE is still developing and some new promising therapeutic options have been proposed. Topical anesthetics, tramadol, and alpha-1 blockers will be the next strategies of the drug treatment for PE in the future.
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Data from various stages of the clinical development programme were analysed using validated methods for assessing ejaculatory latency. The clinical characteristics were then compared with the pharmacokinetic profile, determined from measured plasma drug concentrations.
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Although data extraction from reviews was optimised when more than one review reported data for the same RCT, the reliability of the data extraction within these reviews cannot be guaranteed by this assessment report.
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Measures for de-addiction play an important role in the overall management of ED. The most common co-morbid disorders were urological, like BPH, LUTS, etc, followed by cardiovascular, psychological and diabetes. Overall, rational pharmacotherapy was observed. Tadalafil was the most commonly prescribed drug for ED. The main factor in the selection of a particular PDE5 inhibitor was its pharmacokinetics and cost. Udenafil, being the costliest, was the least prescribed. Dapoxetine was used in a significant number of individuals primarily for PE with ED. The combination of Papaverine, Chlorpromazine ± Alprostadil was used as intracavernosal injection in patients not responding to oral drugs.
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Of 2341 men with baseline and endpoint assessments, 96.8% reported 'very poor' or 'poor' control at baseline, and 748 (32%) reported a two-category or greater increase in control after treatment. More than 95% of those men rated their PE as 'slightly better', 'better', or 'much better' on the PGI; 67.1% gave ratings of 'better' or 'much better.' They also had greater improvements in IELT than men with less than a two-category increase in control, with a mean (sd) change from baseline of 3.7 (4.3) vs 0.77 (1.8) min, respectively, and a greater percentage reported good or very good satisfaction with sexual intercourse than men with less than a two-category increase in control (74% vs 19%, respectively). Nausea, headache and upper respiratory tract infection were the most common adverse events reported by men with a two-category or greater increase in control (15.8%, 7.4% and 6.6%, respectively) and those without (8.5%, 5.5% and 6.5%, respectively). The proportions of men with a two-category or greater increase in control with dapoxetine 30 and 60 mg were 36.3% and 44.5%, respectively (vs 15% with placebo).
To investigate the efficacy and adverse effects of dapoxetine in the treatment of premature ejaculation.
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After a 4-week run-in period, 50 patients with lifelong PE entered a 24-week, open-label, prospective study with a 1:1 assignment. Twenty-five patients (group A) received on-demand dapoxetine 30 mg alone, and the remaining 25 patients (group B) combined on-demand dapoxetine 30 mg and SBTx. The CONSORT 2010 statement was adhered to where possible.
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Dapoxetine demonstrates clinical efficacy and a favorable side effect profile. Dapoxetine is currently the oral drug of choice for on-demand treatment of PE.
The study aims to assess the validity of the patient-reported CGIC measure in men with PE and to examine the relationship between CGIC ratings and assessments of control, satisfaction, personal distress, and interpersonal difficulty.
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We aimed to evaluate the treatment satisfaction, effectiveness and safety of dapoxetine for PE patients.
Premature ejaculation (PE) is a common male sexual disorder. It is defined by the Diagnostic and statistical manual of mental disorders as "ejaculation occurring, without control, on or shortly after penetration and before the person wishes it, causing marked distress or interpersonal difficulty.() Although the timing of intravaginal ejaculatory latency time (IELT) (i.e., time from penetration to ejaculation) is not included in this definition, an IELT of <2 min, or ejaculation occurring before penetration, has been considered consistent with PE.() Management involves both the patient and his partner. Therapeutic options should suit both partners and be appropriate to their habit in planning and frequency of intercourse. Follow-up at appropriate intervals to judge efficacy, titrate dosage of pharmacological treatments and ascertain side effects is mandatory.
Strategies, recommendations and techniques proposed by sex therapy for intervention on premature ejaculation, have represented for nearly four decades the most effective model of intervention in this sexual dysfunction, which currently is complemented by the efficacy of dapoxetine drug treatment. Clinical experience and recent studies support that combined intervention offers the best therapeutic results. In addition in sex therapy, etiologic diagnosis is obtained from the analysis of the interrelationship of the couple. Diagnostic and therapeutic intervention has to be always centered in the relationship, so the techniques and resources must be applied with the expectation of being implemented in the sexual interaction. It will therefore be the relationship that receive treatment, even if medication is used for one of the members of the couple. On the other hand, this model of intervention can be implemented by a professional with training, although not necessarily a specialist.
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Combined dapoxetine and SBTx proved to be more effective than dapoxetine alone in treating patients with lifelong PE, up to restoring a normal ejaculatory function in most of them.
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Dapoxetine is a short-acting selective serotonin reuptake inhibitor developed for the on-demand treatment of premature ejaculation and is approved in some European Union countries, as well as Mexico and Korea, for this indication. The pharmacokinetics of dapoxetine 30 mg and 60 mg in healthy Chinese (single dose), Japanese, and Caucasian men (single and multiple dose) were assessed in 2 studies. In the 3 ethnic groups, dapoxetine was rapidly absorbed following oral administration, with peak plasma concentrations evident approximately 1 hour after dosing, independent of dose, dosing frequency (single or multiple dosing), or ethnicity. Dapoxetine was eliminated in a biphasic manner with an apparent mean terminal half-life of 14 to 17 hours. There was a dose-proportional increase in dapoxetine maximum plasma concentration (C(max)) and area under concentration-time curves (AUCs). The single-dose pharmacokinetic parameters of dapoxetine metabolites were also similar for the 3 ethnic groups, as were the pharmacokinetics of dapoxetine and its metabolites following single and multiple dosing in Caucasian and Japanese men. Dapoxetine was well tolerated by all 3 ethnic groups.
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Premature ejaculation (PE) is the most common male sexual dysfunction. Dapoxetine hydrochloride, belonging to a class of drugs known as selective serotonin reuptake inhibitors or, was the first drug originally approved for the on-demand treatment of men with PE. We aimed to compare the intravaginal ejaculatory latency time (IELT), patient-reported global impression of change (PGIC), and adverse effect (AE) incidence associated with the use of dapoxetine (30 mg and 60 mg) versus placebo, and evaluate the differences in administering 60 mg versus 30 mg as on-demand medical oral therapy for the treatment of PE via a literature review and meta-analysis. Relevant randomized controlled trials (RCTs) were identified from PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (Cochrane Library) databases. Ultimately, a total of seven RCTs with 8039 patients were included. Our meta-analysis demonstrated that dapoxetine (in the 30 mg and 60 mg subgroup) resulted in significantly higher IELT, PGIC, and AE incidence relative to the placebo, with higher proportions observed for 60 mg versus 30 mg of dapoxetine administration. The most common AEs were mild and tolerable. We conclude that dapoxetine (particularly the 60 mg dosage) may be considered a safe and effective drug for patients with PE.
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Previous studies have investigated whether physical activity increases serotonin hormone levels. Serotonin receptor dysfunction is one of the frequently accused factors of premature ejaculation (PE). Nevertheless, no studies up to date have demonstrated that the association between physical activity and premature ejaculation. We aimed to investigate the relationship between physical activity and PE and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE. A total of 105 patients diagnosed with PE were enrolled in this study. Of the patients, 35 were treated with dapoxetine, (30 mg) on demand (Group 1), 35 performed moderate physical activities (Group 2), and 35 performed minimal physical activity (Group 3-sham). Demographic characteristics, metabolic equivalents (MET), premature ejaculation diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT) were recorded. There were no significant differences among three groups in terms of age, BMI, MET, PEDT or IELT before treatment. At the end of the study, there was significant decrease in PEDT scores, and increase in IELT in groups 1 and 2 as compared to Group 3. In conclusion, a moderate physical activity longer than 30 min at least 5 times a week leads to ejaculation delay, and appears as an alternative to dapoxetine on demand for the treatment of PE.
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Well-designed clinical trials utilizing appropriate outcome measurements are needed to provide safe and effective pharmacologic options for men with PE.
Dapoxetine, as the first drug developed for PE, is an effective and safe treatment for PE and represents a major advance in sexual medicine.
Four premature ejaculation (PE) subtypes are distinguished on the basis of the duration of the intravaginal ejaculation latency time (IELT), its course in life, and frequency of complaints. Since the 1930s oral drug treatment and local anesthetics have been used to treat PE. Apart from dapoxetine, all currently available drugs to treat PE (SSRIs, clomipramine, and local anesthetics) are off-label. Not only men with lifelong and acquired PE, but also men with normal IELT values may want to postpone their ejaculation time.
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To investigate the scientific process that has been followed in dapoxetine treatment trials and reviews as compared to daily drug treatment trials and reviews with selective serotonin reuptake inhibitors (SSRIs) in men with PE.
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Premature ejaculation (PE) is the most common sexual problem affecting men. It can affect men at all ages and has a serious impact on the quality of life for men and their partners. Currently there are no pharmaceutical agents approved for use in the UK, and so all drugs used for this condition are off label. Behavioral therapy has been used to treat PE, but the results are not durable once therapy has been concluded. Several topical therapies have been used including severance-secret (SS) cream, lignocaine spray, lidocaine-prilocaine cream and lidocaine-prilocaine spray (TEMPE). There has been recent interest in the selective serotonin reuptake inhibitors (SSRIs) for the treatment of PE, due to the fact that one of their common side effects is delayed ejaculation. Currently used SSRIs have several non-sexual side effects and long half lives, therefore there has been interest in developing a short acting, efficacious SSRI that can be used on-demand for PE. Dapoxetine has been recently evaluated for the treatment of PE by several groups, and results so far appear promising.
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Drug treatment is the first choice of treatment for lifelong premature ejaculation and may also be indicated for acquired premature ejaculation. Together with the patient, the clinician can choose which drug and which treatment strategy is most suitable for the patient and his partner.
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Premature ejaculation is a condition for which the cause is not well understood. Several types of treatment with medium to low efficacy are available. More research is necessary to identify the ideal treatment.