Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation

This study is currently recruiting participants.
Verified by Plethora Solutions Ltd, November 2007

Sponsors and Collaborators: Plethora Solutions Ltd
Sciele Pharma

Information provided by: Plethora Solutions Ltd
ClinicalTrials.gov Identifier: NCT00556478

Purpose
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.

Condition Intervention Phase
Premature Ejaculation
Drug: PSD502, contains a mixture of lidocaine and prilocaine
Drug: PSD502 Placebo
Phase II
Phase III



MedlinePlus related topics: Female Sexual Dysfunction

ChemIDplus related topics: Lidocaine HFA 227 Prilocaine Prilocaine hydrochloride

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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)


Further study details as provided by Plethora Solutions Ltd:


Primary Outcome Measures:
To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by: • changes in mean IELT from baseline to during 3 month double-blind treatment • changes in selected IPE domains from baseline to month 3 [ Time Frame: 3 Months ]


Secondary Outcome Measures:
Change in selected IPE domains from Baseline; Proportion of subjects with short mean IELT during double-blind treatment; Change in mean IELT from Baseline; Subject & Partner PEP scores; Evaluation of safety and tolerability measured by Adverse Event data [ Time Frame: 3 Months ]


Estimated Enrollment: 300
Study Start Date: October 2007
Estimated Study Completion Date: November 2008


Arms Assigned Interventions
Double-Blind Active: Active Comparator
Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. Drug: PSD502, contains a mixture of lidocaine and prilocaine
PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.

Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.

During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing

During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.

Double-Blind Placebo: Placebo Comparator
Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. Drug: PSD502 Placebo
The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.

Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.

During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.

During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.

Open Label Phase: Active Comparator
Subjects will all receive PSD502 if they wish to continue in the trial. Drug: PSD502, contains a mixture of lidocaine and prilocaine
PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.

Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.

During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing

During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.



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.

Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Willing and able to provide written informed consent.
Male and aged 18 years and over.
Diagnosed with PE
Acceptable response to Baseline PEP
Subject must be in a stable heterosexual and monogamous relationship and the partner must provide consent
Acceptable sexual encounters in the Baseline period.
Exclusion Criteria:

Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of Screening.
Subject has erectile dysfunction
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:

Urological disease
Ongoing significant psychiatric disorder not controlled by medication.
Subject has safety testing abnormalities at the Screening Visit
Subjects taking excluded medications or receiving any treatment for PE
Subject, or his sexual partner, has a current history of alcohol or drug abuse,
The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons.
Subject, or his sexual partner, has known drug sensitivity to amide-type local anesthetics.
Subjects with pregnant partners
Subject with sexual partners of child-bearing potential and not using appropriate contraception
Subject, or his sexual partner, has a history of Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents).
Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier: NCT00556478

Contacts


Contact: Lucy Todd +44 (0)207 269 8630 lucy.todd@plethorasolutions.co.uk

Contact: Jenny Wyllie +44 (0)207 269 8630 jenny.wyllie@plethorasolutions.co.uk


Locations


United States, North Carolina
Department of Urology, University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599 - 7254
Contact: Culley Carson, MD 919-966-2574 culley_carson@med.unc.edu
Principal Investigator: Culley Carson, MD


Sponsors and Collaborators


Plethora Solutions Ltd

Sciele Pharma


Investigators


Principal Investigator: Culley Carson, MD University of North Carolina

More Information

Publications:

Dinsmore WW, Hackett G, Goldmeier D, Waldinger M, Dean J, Wright P, Callander M, Wylie K, Novak C, Keywood C, Heath P, Wyllie M. Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation. BJU Int. 2007 Feb;99(2):369-75. Epub 2006 Nov 24.

Morales A, Barada J, Wyllie MG. A review of the current status of topical treatments for premature ejaculation. BJU Int. 2007 Sep;100(3):493-501. Epub 2007 Jul 3. Review.

Henry R, Morales A. Topical lidocaine-prilocaine spray for the treatment of premature ejaculation: a proof of concept study. Int J Impot Res. 2003 Aug;15(4):277-81.



Study ID Numbers: PSD502-PE-002
First Received: November 9, 2007
Last Updated: November 9, 2007
ClinicalTrials.gov Identifier: NCT00556478
Health Authority: United States: Food and Drug Administration


Keywords provided by Plethora Solutions Ltd:
Premature Ejaculation
Lidocaine
Prilocaine
EMLA® cream
topical anesthetics


Study placed in the following topic categories:
EMLA
Prilocaine
Lidocaine


Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on March 21, 2008

Premature Ejaculation Clinical Trial A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296

This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline October 2007

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549211

Purpose
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296. Condition Intervention Phase
Premature Ejaculation
Drug: GSK557296
Phase I

MedlinePlus related topics: Female Sexual Dysfunction

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study
Official Title: A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects
Primary Outcome Measures:
Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs [Time Frame: 24 Hours]

Secondary Outcome Measures:
Blood tests to study how long the drug stays in your blood [Time Frame: 24 Hours]
Further study details as provided by GlaxoSmithKline:
Total Enrollment: 42 Study start: October 2007

Eligibility
Ages Eligible for Study: 18 Years - 45 Years, Genders Eligible for Study: Male
Accepts Healthy Volunteers
CriteriaInclusion Criteria:

Healthy males who are 18 to 45 years of age
Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
Non-smokers
Exclusion Criteria:

Alcohol consumption averaging more than 7 drinks per week
Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
Any use of prescription drugs or non prescription drugs
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00549211

United States, Indiana
GSK Clinical Trials Call Center, Evansville, Indiana, 47714, United States
Stewart Smith 877-379-3718

Study chairs or principal investigators
GSK Clinical Trials, MD, Study Director, GlaxoSmithKline More Information
Study ID Numbers: OTB109039
Last Updated: October 23, 2007
Record first received: October 23, 2007
ClinicalTrials.gov Identifier: NCT00549211
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on October 31, 2007

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