Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210678
Status:
COMPLETED
Last Update Posted:
2012-10-10
First Post:
2005-09-13
Brief Title:
A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R096769-PRE-3004 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |