An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride
Condition: Sexual Dysfunction, Physiological; Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation; Sexual Dysfunction, Physiological
Study type: Observational

Summary: 
      The purpose of the study is to collect information regarding the safety of dapoxetine
      hydrochloride when used in clinical practice to treat men with premature ejaculation.
      Dapoxetine hydrochloride is a selective inhibitor of serotonin reuptake that is indicated for
      the treatment of patients with premature ejaculation.
    

Detailed description: 
      This is a 12-week, observational study to collect and evaluate safety data for dapoxetine
      hydrochloride and alternate care/non-dapoxetine hydrochloride treatment(s) defined as any
      treatment (eg, oral, topical, or behavioral) other than dapoxetine hydrochloride, which have
      been recommended and prescribed for men who have a diagnosis of premature ejaculation. The
      primary objective of the study is to describe the safety profile of dapoxetine hydrochloride
      when used in clinical practice. The safety of dapoxetine hydrochloride will be assessed duing
      the study by monitoring the occurrence of all adverse events experienced by patients
      including adverse events of special interest (eg, syncope, characterized as loss of
      consciousness). Safety will also be assessed by monitoring patient use of all concomitant
      medications/treatments including prescription medications, over the counter medications,
      vitamins and herbal supplements, and other types of therapies such as electrical stimulation,
      acupuncture, special diets, and exercise regimens. Approximately 12,000 men with premature
      ejaculation will be enrolled in the study of which approximately 6,000 patients will be
      treated with dapoxetine hydrochloride. All patients who present to the practice for an
      evaluation of premature ejaculation, or who have a diagnosis of premature ejaculation and are
      currently being treated will be considered for enrollment in the study. All treatment
      decisions will be made at the discretion of the participating health care provider. The study
      will consist of 3 periods: a pre-observational (screening/baseline) period (Visit 1), an
      12-week observational period (Visits 2, 3, and 4), and a 4-week post-observational period. At
      Visit 1, the health care provider will make or confirm the diagnosis of premature ejaculation
      and determine if treatment with dapoxetine hydrochloride or alternate care/non-dapoxetine
      hydrochloride is appropriate for the patient. There will be no study-specific selection
      criteria other than the guidance provided by the Summary of Product Characteristics for
      dapoxetine hydrochloride as it is intended that the participating health care provider will
      use the Summary of Product Characteristics for dapoxetine hydrochloride as a guide to
      identify appropriate patients for the study, and the types of patients who should use caution
      or avoid using dapoxetine hydrochloride. If the healthcare provider determines that the
      patient is a candidate for the study, he/she will explain the details of the study to the
      patient. Patients who are interested in participating in the study should be willing and able
      to be treated with dapoxetine hydrochloride and to continue to participate in the study as
      long as dapoxetine hydrochloride continues to be administered for the duration of the 12-week
      observational period, even in those situations where topical and/or behavioral alternate care
      treatments are added to the dapoxetine hydrochloride treatment regimen. Patients who wish to
      participate in the study will be asked to sign and date an informed consent to allow the
      health care provider to collect information required for the study. At Visit 1, a signed
      informed consent form will be obtained from the patient and information will be collected
      including demographics (for example, the patient's race and age), medical history including
      premature ejaculation history, physical examination findings, and orthostatic vital sign
      (blood pressure and heart rate/pulse) measurements. If the health care provider determines
      that the patient should be treated with dapoxetine hydrochloride, the health care provider
      will instruct the patient on the administration of dapoxetine hydrochloride according to the
      dosage and administration guidelines in the Summary of Product Characteristics for dapoxetine
      hydrochloride as follows: the recommended starting dose of dapoxetine hydrochloride is 30 mg,
      taken with or without food with at least one full glass of water approximately 1 to 3 hours
      prior to prior to sexual activity once every 24 hours as needed. If the effect of dapoxetin
      hydrochloride at a dose of 30 mg is insufficient and the side effects are acceptable, the
      dose may be increased to the maximum recommended dose of 60 mg. If the health care provider
      determines that the patient should be treated with alternate care/non-dapoxetine
      hydrochloride treatment(s), the health care provider will instruct the patient on the
      administration of those treatments as prescribed or directed. Following Visit 1, all patients
      will participate in a 12-week observational period where they will return for up to 3 study
      visits (Visits 2, 3, and 4) according to the health care provider's local practice. At each
      visit, the health care provider will evaluate if the dose of dapoxetine hydrochloride or
      alternate care/non-dapoxetine hydrochloride treatment(s) needs to be increased or decreased
      and information regarding the occurrence of adverse events and the use of concomitant
      medications/treatment will be collected. Approximately 4 weeks following the end of the
      12-week observational period or the patient's last visit in the study, the health care
      provider will contact the patient by telephone to assess the occurrence of any adverse events
      experienced by the patient and the use of any concomitant medications or treatments taken
      since the last study visit. Additional telephone contact with the patient may be performed by
      the health care provider to obtain additional information to determine the patient's safety
      or survival status. Regardless of the patient's status at the end of the study (ie,
      completed, discontinued treatment, withdrew early), patients who receive dapoxetine
      hydrochloride will be asked to complete a survey to provide feedback to the healthcare
      provider on the whether or not the dapoxetine hydrochloride Patient Brochure and/or Patient
      Information Leaflet was useful and informative. Patients may only participate in the study
      one time. Patients who receive dapoxetine hydrochloride in the study should not be enrolled
      again to receive alternate care/non-dapoxetine hydrochloride treatment(s) upon study
      completion or discontinuation of dapoxetine hydrochloride). The recommended starting dose of
      dapoxetine hydrochloride is 30 mg, taken with or without food with at least 1 full glass of
      water approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as
      needed. Patients will take dapoxetine hydrochloride for 12 weeks during the observational
      period of the study. Alternate care/non dapoxetine hydrochloride treatment(s) will be
      administered to patients in accordance with the prescribing information and/or directions for
      use.
    

Intervention name(s): Dapoxetine hydrochloride; Alternate care/non-dapoxetine hydrochloride treatment(s)
Intervention type(s): Drug; Other
Intervention description(s): One 30 mg tablet up to a maximum of one 60 mg tablet approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed for 12 weeks; As prescribed or directed
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men diagnosed with premature ejaculation will be enrolled in the study by participating
        health care providers in clinical practice settings.
      
Keywords: Dapoxetine hydrochloride; Priligy; Premature ejaculation; Non-dapoxetine hydrochloride treatment(s)