(2011) Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials.
- Men should be aware of potential allergic reactions such as rash or swelling.
- Dapoxetine does not affect sexual desire directly.
- It is important to report any persistent or worsening side effects.
- Use caution when scaling doses up, only as advised by a healthcare professional.
- Avoid taking dapoxetine with other medications that affect serotonin levels.
- Stay informed about new research and updates on dapoxetine therapy.
(2014) Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: The PAUSE study.
How to Take Dapoxetine
2006) included in the pooled analysis, the method of allocation described suggests that this was concealed. However, in the other 2 RCTs (McMahon et al. 2009) it is unclear if allocation was concealed. The efficacy outcomes were reported to be based on the intention-to-treat (ITT) population, classed as all randomised participants. However, in the pooled analysis, numbers of participants for whom data were available was also presented.
Mental health history
It is unclear if the analysis was based on the ITT population or the population for whom data were available. Discontinuation rates were high in the studies but were similar for dapoxetine and placebo (31.1% of all participants in the dapoxetine groups and 28.9% of all participants in the placebo groups). For missing data post-baseline, the last post-baseline observation carried forward (LPOCF) method was used. In this approach, regardless of when a patient left the trial (for example, after week 1, week 6 or week 12), the last available result for that patient was carried forward and analysed as though it were the result at the study end. As stated in the summary of product characteristics, the efficacy and safety of dapoxetine in men with both premature ejaculation and erectile dysfunction treated with both dapoxetine and phosphodiesterase type 5 inhibitors (for example, sildenafil) has not been established.
Full Text Sources
The summary of product characteristics states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors. There are limited data tadalafil with dapoxetine tablets available on the safety and efficacy of dapoxetine 'on demand' for longer than 24 weeks. The European Association of Urology 2014 guidelines on male sexual dysfunction recommend that pharmacological treatment options include 'on demand' dapoxetine, daily use of a longer-acting selective serotonin reuptake inhibitor (SSRI) [off-label use], daily use of clomipramine (off-label use), 'on demand' topical local anaesthetic agents (off-label use) and 'on demand' tramadol (off-label use). Because longer-acting SSRIs such as citalopram, fluoxetine or paroxetine have a longer onset of action than the shorter-acting dapoxetine they need to be taken on a daily basis and cannot be used as an 'on demand' treatment. The European Association of Urology 2014 guidelines on male sexual dysfunction states that in men for whom premature ejaculation causes few if any problems treatment should be limited to psychosexual counselling and education. (2013) Dapoxetine treatment in patients with lifelong premature ejaculation: the reasons of a 'Waterloo'.
| Attribute | Description | Notes |
|---|---|---|
| Purpose | Delays ejaculation time during intercourse | Often prescribed for PE |
| Typical Dosage | 30 mg to 60 mg | Taken 1-3 hours before sex |
| Onset of Action | Within 1-3 hours | Peak effect approximately 1 hour after intake |
| Duration of Effect | 2 to 4 hours | Varies per individual |
| Common Side Effects | Nausea, dizziness, headache | Usually mild |
| Contraindications | Use with MAO inhibitors, severe cardiac issues | Consult doctor before use |
(2006) Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated
| Parameter | Guideline |
|---|---|
| Recommended Dose | 30 mg to start; possible increase to 60 mg if needed |
| Timing Before Sex | 1 to 3 hours prior |
| Frequency of Use | No more than once per day |
| Consumption with Food | Usually taken with or without food, consistency advised |
| Alcohol Interaction | Avoid alcohol; increases side effects |
| Precautions | Not suitable for certain health conditions, consult doctor |
analysis of two double-blind, randomized controlled trials Lancet 368: 929–37 The integrated process statement
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 40mg | 60 + 4 Pills | 162.37€ 154.64€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Kamagra 100 mg | 100 mg | 12 Pills | 55.64€ 52.99€ | |
| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ | |
| Priligy Generic Dapoxetine | 60mg | 180 + 10 Pills | 494.76€ 471.20€ | |
| Kamagra Gold | 50 mg | 20 Pills | 73.17€ 69.69€ | |
| Kamagra Effervescent Tablets | 100 mg | 84 + 7 Pills | 202.91€ 193.25€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Priligy Generic Dapoxetine | 60mg | 90 + 10 Pills | 265.64€ 252.99€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ |
sets out the process NICE uses to select topics for the evidence summaries:
- Dapoxetine is marketed under various brand names likePriligy.
- It’s designed specifically for men experiencing premature ejaculation.
- The medication works by increasing serotonin levels in nerve cells.
- Use dapoxetine consistently as prescribed for maximum benefit.
- It is not intended for daily use but as needed before sex.
- Always inform your doctor about other medications to avoid interactions.
new medicines and how the summaries are developed, quality assured and approved for publication.
Delivery Options
For a number of men pharmacological treatment of premature ejaculation will not be acceptable. A prospective observational study from a single clinical centre in Italy (Mondaini et al. 2013) assessed the acceptance and discontinuation rates of 'on demand' dapoxetine 30 mg (titrated to 60 mg after 3 months if low efficacy) in 120 men with lifelong premature ejaculation. Twenty-four (20%) of the men decided not to start dapoxetine. Fear of using a 'drug' was the most frequently reported reason for treatment dapoxetine tadalafil tablets non-acceptance (50%).
Redefining a sexual medicine paradigm: subclinical premature ejaculation as a new taxonomic entity
In addition, the majority of men who took dapoxetine discontinued treatment. The main reasons for treatment discontinuation were efficacy below expectations, side effects and costs. Out of the 96 men who decided to start dapoxetine, only 10 men were continuing the treatment after 1 year. Dapoxetine is the only medicine licensed in the UK for the treatment of premature ejaculation, although other treatments are used off-label for this indication. The General Medical Council advice to use a licensed medicine whenever possible should be taken into consideration.
What is Priligy?
The manufacturer has estimated that based on a GP-registered population of 100,000 people, 5851 men aged 18 to 64 will be affected by premature ejaculation with 1151 men severely affected (A. Menarini Farmaceutica Internazionale: personal communication January 2014). The manufacturer further estimates that 25% of the men severely affected by premature ejaculation will seek treatment and 70% of those seeking treatment could be prescribed dapoxetine. The manufacturer therefore estimates that based on a GP-registered population of 100,000, 202 men aged 18 to 64 may potentially be prescribed dapoxetine over a 5-year period (A. Menarini Farmaceutica Internazionale: personal communication January 2014). Ian Pearce, Consultant Urological Surgeon, Honorary Senior Lecturer, University of Manchester,
- Summary: a targeted on-demand treatment for premature ejaculation.
- Requires professional diagnosis and prescription for safe use.
- Most side effects are mild and manageable.
- Serious risks include serotonin syndrome and syncope.
- Improves ejaculatory control and sexual satisfaction.
- Part of a holistic management strategy.
- Patient education on expectations and safety is paramount.
- Regular medical follow-up ensures optimal and safe use.
Manchester Royal Infirmary Mike Foster, Consultant Urologist, Heart of England NHS Trust
Other Therapy
The manufacturer estimated that in 2013 approximately 75% of European sales of dapoxetine were for the 30 mg strength. Dapoxetine for premature ejaculation was not considered appropriate for a NICE technology appraisal and is not currently planned into any other work programme. There is no NICE guidance on premature ejaculation. A. Menarini Farmaceutica Internazionale (2013) Priligy 30 mg and 60 mg film-coated tablets dapoxetine 5mg summary of product characteristics [online; accessed 12 March 2014] Buvat J, Tesfaye F, Rothman M et al.
Relevance to NICE guidance programmes
(2009) Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. European Association of Urology (2014) Guidelines on male sexual dysfunction [online; accessed 11 April 2014] Kaufman JM, Rosen RC, Mudumbi RV et al. (2009) Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial. (2010) Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. The Journal of Sexual Medicine 7: 256–68 McMahon CG, Althof SE, Kaufman JM et al. Dapoxetine is a medicine used for the treatment of premature ejaculation (a
| Study/Source | Efficacy Rate | Satisfaction Level | Notes |
|---|---|---|---|
| Clinical Trial (2022) | 70-80% | High | Significant improvement in ejaculation latency |
| Patient Surveys (2023) | 75% | Very satisfied | Many report improved sexual confidence |
| Meta-Analysis (2021) | 65-85% | Varies | Effectiveness depends on dosage and severity of PE |
| Long-Term Use Reports (2024) | Maintains benefit | Consistent | Most users report sustained effect over time |
sexual dysfunction in which a man ejaculates too quickly during sexual intercourse).
Available Medicine for Dapoxetine
The guidelines recommend that before beginning treatment, it is essential to discuss the expectations of treatment thoroughly. Various behavioural techniques have demonstrated benefit in treating premature ejaculation and are indicated for men who are uncomfortable with pharmacological therapy. In lifelong premature ejaculation, the European guidelines state that behavioural techniques are not recommended for first-line treatment because they are time-intensive, require the support of a partner and can be difficult to do. The guidelines recommend that pharmacological treatment options include 'on demand' dapoxetine and daily use of a longer-acting SSRI such as citalopram, fluoxetine or paroxetine (off-label use) or daily use of clomipramine (off-label use). Dapoxetine is taken 'on demand' approximately 1 to 3 hours before anticipated sexual activity.
Search strategy
This may reduce the incidence of SSRI-related adverse effects compared with the off-label use of once-daily longer acting SSRIs, although there are no direct RCTs to provide evidence for this. However, some men may prefer to take a daily dose which may allow more spontaneity than a planned 'on demand' treatment. Dapoxetine is licensed for treating premature ejaculation in adult men aged 18 to 64 years. The summary of product characteristics states that dapoxetine should only be prescribed to men who meet all the following criteria: An intravaginal ejaculatory latency time of less than 2 minutes and An intravaginal ejaculatory latency time of less than 2 minutes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the man wishes and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation and A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. Therefore, men will need to be appropriately assessed and given a diagnosis of premature ejaculation in line with the above criteria before dapoxetine can be considered.
Corresponding author
In addition, the summary of product characteristics states that a careful appraisal of the individual benefit/risk ratio should be carried out after the first 4 weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment is appropriate. If dapoxetine is continued, the benefit/risk balance should be re-evaluated at least every 6 months. Consideration will need to be given to how treatment efficacy can be assessed given the subjective nature of efficacy outcomes. Premature ejaculation can occur in conjunction with erectile dysfunction and the European Association of Urology 2014 guidelines on male sexual dysfunction states that if premature ejaculation is secondary to erectile dysfunction then the erectile dysfunction should be treated before or at the same time as the premature ejaculation. It should be noted however, that the summary of product characteristics states that dapoxetine should not be used in men taking phosphodiesterase type 5 inhibitors (for example, sildenafil) as this increases the risk of syncope. This medicine helps in increasing the time taken to ejaculate and achieving better control over ejaculation during sexual intercourse.