Ignite Creation Date:
2024-05-05 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00556478
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2007-11-09
Brief Title:
Efficacy Safety and Tolerability of PSD502 a Topical Anesthetic in the Treatment Premature Ejaculation
Sponsor:
Plethora Solutions Ltd
Organization:
Plethora Solutions Ltd
Study Overview
Official Title:
A Phase IIb Multi-center Randomized Double-blind Placebo-controlled Study With Open-label Follow on to Evaluate the Efficacy Safety and Tolerability of PSD502 in Subjects With Premature Ejaculation PE
Status:
COMPLETED
Status Verified Date:
2016-09
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 this study is to evaluate the effectiveness safety and tolerability of the investigational drug PSD502 in subjects with premature ejaculation PE The study drug PSD02 is a metered dose measured dose topical applied to the skin surface anesthetic numbing spray containing a mixture of lidocaine and prilocaine The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation
Detailed Description:
Most studies evaluating treatments PE include intravaginal ejaculatory latency time IELT in the definition of PE It has been estimated that PE affects 30-40 of the male population but is paradoxically a condition for which they are least likely to seek help
Men with PE exhibit abnormal autonomic reflex pathways for the ejaculatory process These include lower vibratory threshold to ejaculation shorter bulbocavernous latency time and higher bulbocavernous evoked potentials Reducing the heightened sensitivity of the glans penis with topical anesthetics might therefore be a way of improving IELT without adversely affecting the sensation of ejaculation
Although IELT is an objective measure of ejaculatory function it does not address the impact of therapy on patients well being and confidence in their sexual performance which are important markers of treatment benefit Therefore if IELT is used as a sole efficacy measure it may not fully characterise the treatment benefit to the patient For this reason a patient reported outcome PRO known as the Index of Premature Ejaculation IPE will be used in this study in conjunction with IELT to evaluate efficacy Thus the combination of the objective measure of ejaculatory latency with the PRO of IPE should be able to provide efficacy data which are representative of clinical benefit to the patient
The use of lidocaine prilocaine and EMLA cream as topical anesthetics is well established Many years of experience of use in large numbers of patients as well as comprehensive non-clinical safety testing programs for various formulations of lidocaine and prilocaine exist to support their safety and tolerability This information together with the clinical data from 3 studies with PSD502 ANAE-059-00 PSD502-PE-001 and PSD502-PE-003 suggest that PSD502 may have beneficial effects in reducing penile sensation and prolonging IELT and its use is unlikely to be associated with significant clinical safety or tolerability concerns
The aim of this study is to provide additional placebo-controlled efficacy data to establish the clinical utility of PSD502 in the treatment of PE In addition long term open-label efficacy and safety data will be collected to further support the registration package for PSD502 in the indication of treatment of PE
Men with PE exhibit abnormal autonomic reflex pathways for the ejaculatory process These include lower vibratory threshold to ejaculation shorter bulbocavernous latency time and higher bulbocavernous evoked potentials Reducing the heightened sensitivity of the glans penis with topical anesthetics might therefore be a way of improving IELT without adversely affecting the sensation of ejaculation
Although IELT is an objective measure of ejaculatory function it does not address the impact of therapy on patients well being and confidence in their sexual performance which are important markers of treatment benefit Therefore if IELT is used as a sole efficacy measure it may not fully characterise the treatment benefit to the patient For this reason a patient reported outcome PRO known as the Index of Premature Ejaculation IPE will be used in this study in conjunction with IELT to evaluate efficacy Thus the combination of the objective measure of ejaculatory latency with the PRO of IPE should be able to provide efficacy data which are representative of clinical benefit to the patient
The use of lidocaine prilocaine and EMLA cream as topical anesthetics is well established Many years of experience of use in large numbers of patients as well as comprehensive non-clinical safety testing programs for various formulations of lidocaine and prilocaine exist to support their safety and tolerability This information together with the clinical data from 3 studies with PSD502 ANAE-059-00 PSD502-PE-001 and PSD502-PE-003 suggest that PSD502 may have beneficial effects in reducing penile sensation and prolonging IELT and its use is unlikely to be associated with significant clinical safety or tolerability concerns
The aim of this study is to provide additional placebo-controlled efficacy data to establish the clinical utility of PSD502 in the treatment of PE In addition long term open-label efficacy and safety data will be collected to further support the registration package for PSD502 in the indication of treatment of 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