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A Study to Evaluate Intravaginal Ejaculation Times in Men With and Without Premature Ejaculation
This study has been completed.
First Received: September 13, 2005   Last Updated: October 11, 2007   History of Changes
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210678
  Purpose

The purpose of the study is to characterize intravaginal ejaculatory latency time in men with and without premature ejaculation and to assess the validity of patient-reported outcomes.


Condition Phase
Erectile Dysfunction
Phase III

Study Type: Observational
Study Design: Prospective
Official Title: An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Estimated Enrollment: 850
Study Start Date: March 2005
Estimated Study Completion Date: September 2005
Detailed Description:

Premature ejaculation (PE) is a form of male sexual dysfunction. In the assessment of PE, an objective measurement is the intravaginal ejaculatory latency time (IELT); subjective measures include ejaculatory control and satisfaction with sexual intercourse. This is a multinational, multicenter, observational study in men with and without PE. The study consists of three visits: one visit for screening and enrollment, and two visits for observation after 1 and 2 months (total duration of 8 weeks). No study treatment for PE is administered to patients during the course of the study. Patients and their partners are expected to attempt sexual intercourse at least 2 times a week during the 8-week study period and to use a stopwatch to record the IELT during intercourse. At visits during the observation period they also provide patient-reported outcomes (PROs) by answering several questionnaires that include the topics of control over ejaculation, satisfaction with sexual intercourse, personal distress, interpersonal difficulty, and self-esteem. The study will estimate the distribution of the average intravaginal ejaculatory latency time values for men with PE and men without PE.

No study treatments are administered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is in a stable, monogamous, sexual relationship with the same woman (18 years of age or older) for at least 6 months, who plan to maintain their relationship for the duration of the study
  • Good general health
  • Patient and partner willing to avoid situations or activities that may have an effect on their sexual activity (for example, refrain from any preplanned surgery)

Exclusion Criteria:

  • History of drug abuse within the past 2 years
  • History of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism
  • Diagnosis of depressive or anxiety disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), or treatment within the past 2 years for a depressive or anxiety disorder (other than sexual performance/premature ejaculation)
  • Patients with Erectile Dysfunction (ED)
  • Patient who has decreased interest in sexual intercourse or has other forms of sexual dysfunction
  • Patient whose partner has decreased interest in sexual intercourse, painful intercourse, or other forms of female sexual dysfunction
  • Patient whose partner is more than 3 months pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210678

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Study ID Numbers: CR004225
Study First Received: September 13, 2005
Last Updated: October 11, 2007
ClinicalTrials.gov Identifier: NCT00210678     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
sexual dysfunction
ejaculation
premature ejaculation
orgasmic disorder
dapoxetine
sexual intercourse

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

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

ClinicalTrials.gov processed this record on September 02, 2009