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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• In accordance with the therapeutic indication stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be candidates for enrollment if they have an intravaginal ejaculatory latency time of less than two minutes

• Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes

• Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation

• Poor control over ejaculation

Exclusion Criteria:

• In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients

• Significant pathological cardiac conditions such as: heart failure (New York Heart Association [NYHA] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease

• Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI

• Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs)] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)

• Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.

• Moderate and severe hepatic impairment