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

An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs)	Association between IELT and PROs used in this study will be explored.	Up to Week 8
Utility of the Male Sexual Function Scale and Ejaculation Questionnaires	The study will explore utility of the Male Sexual Function Scale and Ejaculation Questionnaire as screening instruments.	Day 1
PROs and IELT as indicators to clasify PE status.	The study will evaluate the ability of PROs and IELT to classify PE status	Up to Week 8

Collaborators and Investigators

• Sponsor: 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Dapoxetine; Premature ejaculation; Ejaculation; Sexual dysfunction; Orgasmic disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Erectile Dysfunction; Premature Ejaculation
• Other Study ID Numbers: CR004225; R096769-PRE-3004 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC)