Condition category
Mental and Behavioural Disorders
Date applied
13/01/2009
Date assigned
27/03/2009
Last edited
28/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Carson Culley

ORCID ID

Contact details

Department of Urology
University of North Carolina
Chapel Hill
North Carolina
27599-7254
United States of America
+1 919 966 2574
carson@med.unc.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00556478

Protocol/serial number

PSD502

Study information

Scientific title

A phase IIb, multicentre, randomised, 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)

Acronym

Study hypothesis

PSD502 is a metered dose spray containing a mixture of lidocaine and prilocaine which is under development by Plethora Solutions Ltd as a topical anaesthetic treatment for premature ejaculation (PE). The spray is applied to the glans penis a short time prior to intercourse. Most studies evaluating treatments for PE include intravaginal ejaculatory latency times (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 this heightened sensitivity of the glans with topical anaesthetics 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 in this study, a patient reported outcome (PRO) known as the Index of Premature Ejaculation will be used 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 anaesthetics 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 three 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.

As of 28/01/2010 this record was updated to include changes to the completed trial protocol. At this time, the anticipated start and end dates were updated; the initial trial dates were:
Initial anticipated start date: 05/01/2009
Initial anticipated end date: 31/12/2009
At this time, the target number of participants was also updated; the initial target number of participants was 240 - 300 total (100 in Poland). All other changes can be found under the relevant field with the above update date.

Ethics approval

1. Poland: Local Medical Ethics Committee (Komisja Bioetyczna Uniwersytetu Medycznego) gave approval on the 25th September 2008 (ref: R-I-002/281/2008)
2. USA: Schulman Associates Institutional Board gave approval on the 17th October 2008 (ref: IRB # 07-4087-0)
3. Canada: Trafalgar Ethics Board gave approval on the 4th October 2008 (ref: IRB# 07-023)

Study design

Phase IIb multicentre randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Premature ejaculation

Intervention

PSD502 is a metered dose aerosol spray that delivers a eutectic mixture of lidocaine and prilocaine. The placebo is a metered dose aerosol spray that is identical in appearance to PSD502 spray and contains the same propellant. Subjects will be randomised to PSD502 or placebo in a 2:1 ratio. A single dose of PSD502 or placebo consist of three sprays applied to the glans penis. Subjects will continue for a three-month double-blind treatment followed by 5 months of open-label treatment.

Intervention type

Drug

Phase

Phase II/III

Drug names

PSD502 (containing lidocaine and prilocaine)

Primary outcome measures

Current information as of 28/01/2010:
To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:
1. Changes in mean IELT from baseline to during three-month double-blind treatment
2. Changes in all IPE domains from baseline to month three

Initial information at time of registration:
To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:
1. Changes in mean IELT from baseline to during three-month double-blind treatment
2. Changes in selected IPE domains from baseline to month three

Secondary outcome measures

Current information as of 28/01/2010:
1. Proportion of subjects with short mean IELT during the three months of double-blind treatment
2. Relationship between IELT and IPE
3. Change in mean IELT from baseline
4. Subject and partner PEP scores
5. Evaluation of the safety and tolerability of PSD502 compared with placebo in subjects with PE as measured by adverse events (AE) and serious adverse events (SAE) data for both the subject and his sexual partner, collected throughout the study

Initial information at time of registration:
1. Change in selected IPE domains from baseline to three months
2. Proportion of subjects with short mean IELT during the three months of double-blind treatment
3. Relationship between IELT and IPE
4. Change in mean IELT from baseline
5. Subject and partner PEP scores
6. Evaluation of the safety and tolerability of PSD502 compared with placebo in subjects with PE as measured by adverse events (AE) and serious adverse events (SAE) data for both the subject and his sexual partner, collected throughout the study

Overall trial start date

24/10/2007

Overall trial end date

14/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 28/01/2010:
A subject will be considered suitable for the study if he fulfills all of the following criteria:
1. Willing and able to provide written informed consent
2. Male, aged 18 years and over
3. Diagnosed with PE according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) crietria and International Society for Sexual Medicine (ISSM) definition
4. Diagnosed with lifelong PE
5. Acceptable response to screening Premature Ejaculation Profile (PEP)
6. Subject must be in a stable heterosexual and monogamous relationship and their partner must provide consent
7. Acceptable sexual encounters in the baseline period

Initial information at time of registration:
A subject will be considered suitable for the study if he fulfills all of the following criteria:
1. Willing and able to provide written informed consent
2. Male, aged 18 years and over
3. Diagnosed with PE
4. Acceptable response to screening Premature Ejaculation Profile (PEP)
5. Subject must be in a stable heterosexual and monogamous relationship and their partner must provide consent
6. Acceptable sexual encounters in the baseline period

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

256 total (103 in Poland)

Participant exclusion criteria

A subject, or his sexual partner where stated, who fulfil any of the following criteria will be excluded from the study:
1. Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of screening
2. Subject has erectile dysfunction
3. The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:
3.1. Urological disease
3.2. Ongoing significant psychiatric disorder not controlled by medication
4. Subject has safety testing abnormalities at the screening visit
5. Subjects taking excluded medications or receiving any treatment for PE
6. Subject, or his sexual partner, has a current history of alcohol or drug abuse
7. The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons
8. Subject, or his sexual partner, has known drug sensitivity to amide-type local anaesthetics
9. Subjects with pregnant partners
10. Subject with sexual partners of child-bearing potential and not using appropriate contraception
11. Subject, or his sexual partner, has a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or use of medications that would increase susceptibility to methemoglobinaemia
12. Subject, or his sexual partner, uses class I (e.g. mexiletine, tocainide) or III (e.g. amiodarone, sotalol) anti-arrhythmic drugs

Recruitment start date

24/10/2007

Recruitment end date

14/10/2009

Locations

Countries of recruitment

Canada, Poland, United States of America

Trial participating centre

Department of Urology
North Carolina
27599-7254
United States of America

Sponsor information

Organisation

Plethora Solutions Ltd (UK)

Sponsor details

4th Floor
233 High Holborn
London
WC1V 7DN
United Kingdom
+44 (0)20 3077 5400
mail@plethorasolutions.co.uk

Sponsor type

Industry

Website

http://www.plethorasolutions.co.uk/index.php

Funders

Funder type

Industry

Funder name

Sciele Pharma, Inc (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Plethora Solutions Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes