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

Study Overview
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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.

Official Title
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An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Behavioral: No intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group: 1<br>Men with premature ejaculation (PE) | Behavioral: No intervention<br>* No treatment is given to the patients as this is an observational study.<br>|
| Group: 2<br>Men without PE | Behavioral: No intervention<br>* No treatment is given to the patients as this is an observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intravaginal Ejaculatory Latency Time (IELT) | Estimated distribution of the average IELT for both the premature ejaculation (PE) and non-PE populations will be calculated. | Day 1 to Week 8 | 
| Change in Patient-Reported Outcomes (PRO) | 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). | Week 4 and Week 8 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Dapoxetine, Premature ejaculation, Ejaculation, Sexual dysfunction, Orgasmic disorder