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

Information source: Plethora Solutions Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premature Ejaculation

Intervention: PSD502, contains a mixture of lidocaine and prilocaine (Drug); PSD502 Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Plethora Solutions Ltd

Official(s) and/or principal investigator(s):
Culley Carson, MD, Principal Investigator, Affiliation: University of North Carolina

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.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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 all 3 IPE domains from baseline to month 3

Secondary outcome: 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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Willing and able to provide written informed consent.

- Male and aged 18 years and over.

- Diagnosed with PE according to DMS-IV criteria and ISSM definition

- Diagnosed with lifelong 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).

Locations and Contacts

Department of Urology, University of North Carolina, Chapel Hill, North Carolina 27599 - 7254, United States
Additional Information

Related 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.

Starting date: October 2007
Last updated: July 14, 2010

Page last updated: August 23, 2015

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