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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01021670
First received: November 25, 2009
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction, Physiological
Ejaculation
 Drug: Dapoxetine hydrochloride
Other: Alternate care/non-dapoxetine hydrochloride treatment(s)
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study of Men With Premature Ejaculation Who Are Treated With PRILIGY or Alternate Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The primary outcome measure is safety. Safety will be assessed by monitoring the occurrence of adverse events and the use of concomitant medications or therapies during the study. [ Time Frame: Safety will be assessed at Visit 1 through 4 during the 12 week observation period and up to approximately 4 weeks after the End-of-Observation/Early Withdrawal Visit. ] [ Designated as safety issue: Yes ]

Enrollment: 10027
Study Start Date: September 2009
Study Completion Date: September 2012
Groups/Cohorts Assigned Interventions
001
Dapoxetine hydrochloride 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
 Drug: Dapoxetine hydrochloride
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
002
Alternate care/non-dapoxetine hydrochloride treatment(s) As prescribed or directed
 Other: Alternate care/non-dapoxetine hydrochloride treatment(s)
As prescribed or directed

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  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021670

  Show 214 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01021670     History of Changes
Other Study ID Numbers: CR016477, The PAUSE Study, R096769PRE4001
Study First Received: November 25, 2009
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen Research & Development, LLC:
Dapoxetine hydrochloride
Priligy
Premature ejaculation
Non-dapoxetine hydrochloride treatment(s)

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Sexual and Gender Disorders
 Mental Disorders
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013