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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210678
• Other study ID #: CR004225
• Secondary ID: R096769-PRE-3004
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 9, 2012
• Start date: March 2005
• Est. completion date: September 2005

Study information

• Verified date: October 2012
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None due to the nature of the study (Registry)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1115
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Premature Ejaculation

Intervention

Behavioral:
• No intervention
No treatment is given to the patients as this is an observational study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No