A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation - Full Text View

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:

MedlinePlus related topics: Erectile Dysfunction

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 (Adult, Senior)
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


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:


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

ClinicalTrials.gov processed this record on September 23, 2016