Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation

P

Pusan National University

Status

Unknown

Conditions

Premature Ejaculation

Treatments

Drug: Dapoxetine

Study type

Observational

Funder types

Other

Identifiers

NCT03018743
PNU-Dapoxetine

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Male

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

dapoxetine treatment group
Description:
Consecutive patients who seek medical treatment for PE will be enrolled in the study.
Treatment:
Drug: Dapoxetine

Trial contacts and locations

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Central trial contact

Hyun Jun Park

Data sourced from clinicaltrials.gov

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