A Study to Evaluate Intravaginal Ejaculation Time in Men... | NCT00210678

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

NCT00210678

Sponsor

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

Status

Completed

Last Update Posted

Oct 10, 2012Estimated

Enrollment

1,115Actual

Phase

Not provided

Conditions

Erectile Dysfunction

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R096769-PRE-3004	Other Identifier	Johnson & Johnson Pharmaceutical Research & Development, LLC

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Sep 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2012

Last Update Posted Date

Oct 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group: 1		Men with premature ejaculation (PE)	Behavioral: No intervention
Group: 2		Men without PE	Behavioral: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Behavioral	No treatment is given to the patients as this is an observational study.	Group: 1 Group: 2

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction
D061686	Premature Ejaculation
D012735	Sexual Dysfunction, Physiological
D020018	Sexual Dysfunctions, Psychological

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided