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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00210678

Collaborator

(none)

1,115

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Behavioral: No intervention

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1115 participants

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Sep 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change in Intravaginal Ejaculatory Latency Time (IELT) [Day 1 to Week 8]
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) [Week 4 and Week 8]
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) [Up to Week 8]
Association between IELT and PROs used in this study will be explored.
Utility of the Male Sexual Function Scale and Ejaculation Questionnaires [Day 1]
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. [Up to Week 8]
The study will evaluate the ability of PROs and IELT to classify PE status

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

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.