Clinical trial NCT03018743: Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation
Official title: Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: a 2-year Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Ejaculation
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 200
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients who seek medical treatment for PE will be enrolled in the study.

Brief summary: Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction.

Until now dapoxetine is the only approved medical treatment option and there is no second line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of the factors that lead to dropout is needed especially in a real-practice setting.

With this background, investigators are going to assesse the discontinuation rate of dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical setting throughout a follow-up period of 2 years.

Detailed description: Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction. PE can deteriorate sexual satisfaction and quality of life of the patients and their partners. Recently, the International Society for Sexual Medicine (ISSM) gave a definition that PE is a 'male sexual dysfunction characterized by ejaculation that always or nearly always occurs prior to or within 1 min of vaginal penetration from the first sexual experience (lifelong PE), or a clinically significant reduction in latency time, often to about 3 min or less (acquired PE)' . Until now, several treatment modalities for PE have been introduced. Psychological/behavioral; pharmacologic therapies, including selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, tramadol, phosphodiesterase 5 inhibitor, alpha 1-andreoreceptor antagonists; topical anaesthetics, and even surgical treatments have been used for PE in practice. Dapoxetine is the first oral pharmacological agent developed for the treatment of PE and the only SSRI approved in more than 60 countries for PE. The introduction of dapoxetine was accompanied with high expectation because of the optimal efficacy/ safety profile showed in the phase 3 trials. However, several clinical studies using depoxetine confirmed the efficacy in increasing IELT, it reveals significant dropout rate likely which was shown in the treatment using off-label SSRIs. Despite high efficacy and safety, discontinuation rate of dapoxetine is high compared to PDE5 inhibitors in patients with erectile dysfunction (ED).

Until now dapoxetine is the only approved medical treatment option and there is no second line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of the factors that lead to dropout is needed especially in a real-practice setting. With this background, investigators will assesse the discontinuation rate of dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical setting throughout a follow-up period of 2 years.

Eligibility criteria: Inclusion Criteria:

* men without history of dapoxetine treatment;
* \> 19 years old; and involvement in a stable,
* monogamous relationship with a female sexual partner

Exclusion Criteria:

* penile anatomical deformity;
* spinal cord injury;
* radical prostatectomy;
* pelvic organ surgery;
* diagnosis of another sexual disorder except ED;
* an uncontrolled psychiatric disorder;
* history of major hematological, renal, or hepatic abnormalities;
* a history of alcoholism or substance abuse;
* organic illness causing limitations in assuming SSRIs

Primary outcomes:
measure: Discontinuation rate of dapoxetine treatment
timeFrame: 1 month after initiating therapy
measure: Discontinuation rate of dapoxetine treatment
timeFrame: 3 months after initiating therapy
measure: Discontinuation rate of dapoxetine treatment
timeFrame: 6 months after initiating therapy
measure: Discontinuation rate of dapoxetine treatment
timeFrame: 12 months after initiating therapy
measure: Discontinuation rate of dapoxetine treatment
timeFrame: 24 months after initiating therapy
Secondary outcomes:
measure: Reasons of discontinuation of dapoxetine treatment
timeFrame: 1 month after initiating therapy
measure: Reasons of discontinuation of dapoxetine treatment
timeFrame: 3 months after initiating therapy
measure: Reasons of discontinuation of dapoxetine treatment
timeFrame: 6 months after initiating therapy
measure: Reasons of discontinuation of dapoxetine treatment
timeFrame: 12 months after initiating therapy
measure: Reasons of discontinuation of dapoxetine treatment
timeFrame: 24 months after initiating therapy
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Urology, Pusan National University Hospital
Study officials:
References: