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

NCT00210678 | Completed

• 2 other identifiers: CR004225R096769-PRE-3004
• Study Type: observational
• Target: 1,115
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Dapoxetine; Premature ejaculation; Ejaculation; Sexual dysfunction; Orgasmic disorder

Outcome Measures

Primary Outcomes (2)

• Change in Intravaginal Ejaculatory Latency Time (IELT)

  Estimated distribution of the average IELT for both the premature ejaculation (PE) and non-PE populations will be calculated.

  Day 1 to Week 8

• Change in Patient-Reported Outcomes (PRO)

  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).

  Week 4 and Week 8

Secondary Outcomes (3)

• Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs)

  Up to Week 8

• Utility of the Male Sexual Function Scale and Ejaculation Questionnaires

  Day 1

• PROs and IELT as indicators to clasify PE status.

  Up to Week 8

Study Arms (2)

Group: 1

Men with premature ejaculation (PE)

Behavioral: No intervention

Group: 2

Men without PE

Behavioral: No intervention

Interventions

No intervention BEHAVIORAL

No treatment is given to the patients as this is an observational study.

Group: 1; Group: 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Erectile Dysfunction; Premature Ejaculation; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Mental Disorders; Ejaculatory Dysfunction

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: October 10, 2012

Record last verified: 2012-10