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

NCT ID: NCT00210678

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction Dapoxetine Premature ejaculation Ejaculation Sexual dysfunction Orgasmic disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group: 1

Men with premature ejaculation (PE)

No intervention

Intervention Type BEHAVIORAL

No treatment is given to the patients as this is an observational study.

Group: 2

Men without PE

No intervention

Intervention Type BEHAVIORAL

No treatment is given to the patients as this is an observational study.

Interventions

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No intervention

No treatment is given to the patients as this is an observational study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Other Identifiers

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R096769-PRE-3004

Identifier Type: OTHER

Identifier Source: secondary_id

CR004225

Identifier Type: -

Identifier Source: org_study_id