A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation
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ClinicalTrials.gov Identifier: NCT00210678 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : October 10, 2012
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Condition or disease | Intervention/treatment |
---|---|
Erectile Dysfunction | Behavioral: No intervention |
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 |
Group/Cohort | Intervention/treatment |
---|---|
Group: 1
Men with premature ejaculation (PE)
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Behavioral: No intervention
No treatment is given to the patients as this is an observational study. |
Group: 2
Men without PE
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Behavioral: No intervention
No treatment is given to the patients as this is an observational study. |
- 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.
- 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).
- 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.
- 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.
- 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

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210678
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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 Key Record Dates |
Last Update Posted: | October 10, 2012 |
Last Verified: | October 2012 |
Erectile Dysfunction Dapoxetine Premature ejaculation |
Ejaculation Sexual dysfunction Orgasmic disorder |
Premature Birth Erectile Dysfunction Premature Ejaculation Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |