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

• ClinicalTrials.gov Identifier: NCT00210678
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: October 10, 2012
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Information provided by (Responsible Party): Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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
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: March 2005
• Actual Primary Completion Date: September 2005
• Actual Study Completion Date: September 2005

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Day 1 to Week 8 ]
   Estimated distribution of the average IELT for both the premature ejaculation (PE) and non-PE populations will be calculated.
2. Change in Patient-Reported Outcomes (PRO) [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

• Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• ClinicalTrials.gov Identifier: NCT00210678
• Other Study ID Numbers: CR004225; R096769-PRE-3004 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, LLC )
• First Posted: September 21, 2005
• Last Update Posted: October 10, 2012
• Last Verified: October 2012

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:

Premature Birth; Erectile Dysfunction; Premature Ejaculation; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Genital Diseases, Male; Sexual Dysfunctions, Psychological; Mental Disorders