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

9. oktober 2012 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1115

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

One thousand patients (at least 200 men with premature ejaculation (PE) and at least 800 men without PE) will be enrolled in the study.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group: 1
Men with premature ejaculation (PE)
Adfærdsmæssigt: No intervention
No treatment is given to the patients as this is an observational study.
Group: 2
Men without PE
Adfærdsmæssigt: No intervention
No treatment is given to the patients as this is an observational study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Intravaginal Ejaculatory Latency Time (IELT)
Tidsramme: Day 1 to Week 8
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)
Tidsramme: 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).
Week 4 and Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs)
Tidsramme: Up to Week 8
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
Tidsramme: Day 1
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.
Tidsramme: Up to Week 8
The study will evaluate the ability of PROs and IELT to classify PE status
Up to Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

  • Studieleder: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2005

Primær færdiggørelse (Faktiske)

1. september 2005

Studieafslutning (Faktiske)

1. september 2005

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

13. september 2005

Først opslået (Skøn)

21. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR004225
  • R096769-PRE-3004 (Anden identifikator: Johnson & Johnson Pharmaceutical Research & Development, LLC)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Erektil dysfunktion

Kliniske forsøg med No intervention

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uruguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner