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A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210678
First received: September 13, 2005
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to assess the validity of patient-reported outcomes.


Condition Intervention Phase
Erectile Dysfunction
 Behavioral: No intervention
 Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Day 1 to Week 8 ] [ Designated as safety issue: No ]
    Estimated distribution of the average IELT for both the premature ejaculation (PE) and non-PE populations will be calculated.

  • Change in Patient-Reported Outcomes (PRO) [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
    Additional evidence of reliability and validity of PROs for patients with and without PE and their partners will be expolred. The PROs will include different parameters related to (control over ejaculation, satisfaction with sexual intercourse, personal distress, and interpersonal difficulty).


Secondary Outcome Measures:
  • Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs) [ Time Frame: Up to Week 8 ] [ Designated as safety issue: No ]
    Association between IELT and PROs used in this study will be explored.

  • Utility of the Male Sexual Function Scale and Ejaculation Questionnaires [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The study will explore utility of the Male Sexual Function Scale and Ejaculation Questionnaire as screening instruments.

  • PROs and IELT as indicators to clasify PE status. [ Time Frame: Up to Week 8 ] [ Designated as safety issue: No ]
    The study will evaluate the ability of PROs and IELT to classify PE status
Enrollment: 1115
Study Start Date: March 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group: 1
Men with premature ejaculation (PE)
 Behavioral: No intervention
No treatment is given to the patients as this is an observational study.
Group: 2
Men without PE
 Behavioral: No intervention
No treatment is given to the patients as this is an observational study.

Detailed Description:

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 intravaginal ejaculatory latency time (IELT) during intercourse. At visits during the observation period "patients" (and/or partners if partners are responsible for completing questionaires) 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 IELT values for men with PE and men without PE.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

One thousand patients (at least 200 men with premature ejaculation (PE) and at least 800 men without PE) will be enrolled in the study.

Criteria

Inclusion Criteria:

  • Must be 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
  • Must be in good general health
  • Patient and partner willing to avoid situations or activities that may have an effect on their sexual activity (eg, refrain from any preplanned surgery)

Exclusion Criteria:

  • Has history of drug abuse within the past 2 years
  • Has history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism
  • Must have erectile dysfunction
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 & Development, LLC Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210678     History of Changes
Other Study ID Numbers: CR004225, R096769-PRE-3004
Study First Received: September 13, 2005
Last Updated: October 9, 2012
Health Authority: United States: None due to the nature of the study (Registry)

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Erectile Dysfunction
Dapoxetine
Premature ejaculation
 Ejaculation
Sexual dysfunction
Orgasmic disorder

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

ClinicalTrials.gov processed this record on February 27, 2015