Clinical trial NCT00210678: A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation
Official title: An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Dapoxetine
Premature ejaculation
Ejaculation
Sexual dysfunction
Orgasmic disorder
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 1115
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Change in Intravaginal Ejaculatory Latency Time (IELT)
timeFrame: Day 1 to Week 8
measure: Change in Patient-Reported Outcomes (PRO)
timeFrame: Week 4 and Week 8
Secondary outcomes:
measure: Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs)
timeFrame: Up to Week 8
measure: Utility of the Male Sexual Function Scale and Ejaculation Questionnaires
timeFrame: Day 1
measure: PROs and IELT as indicators to clasify PE status.
timeFrame: Up to Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: