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

NCT00556478 | Completed Phase 2 Results

• 1 other identifier: PSD502-PE-002
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ejaculation

Keywords

Premature Ejaculation; Lidocaine; Prilocaine; EMLA® cream; topical anesthetics

Outcome Measures

Primary Outcomes (2)

• Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment

  To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by: • change in mean IELT from baseline to during the 3 month double-blind treatment Results provide are ratio (over the 3 months/baseline).

  Baseline to 3 Months

• Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3

  To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by: • changes in all 3 IPE domains from baseline to month 3 Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress

  Baseline to 3 Months

Secondary Outcomes (8)

• Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment

  3 months

• Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3

  3 months

• Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1

  1 month

• Subject PEP at Month 1

  1 month

• Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2

  2 months

Study Arms (3)

Double-Blind Active

ACTIVE COMPARATOR

Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.

Drug: PSD502, contains a mixture of lidocaine and prilocaine

Double-Blind Placebo

PLACEBO COMPARATOR

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Drug: Placebo

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

Interventions

PSD502, contains a mixture of lidocaine and prilocaine DRUG

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 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 Active; Open Label Phase

Placebo DRUG

The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray 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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Plethora Solutions Ltd: lead
• Shionogi Inc.: collaborator

Study Sites (1)

Department of Urology, University of North Carolina

Chapel Hill, North Carolina, 27599 - 7254, United States

Location

Related Publications (3)

• 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. doi: 10.1111/j.1464-410X.2006.06583.x. Epub 2006 Nov 24.

  PMID: 17129234 BACKGROUND

• 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. doi: 10.1111/j.1464-410X.2007.07051.x. Epub 2007 Jul 3.

  PMID: 17608824 BACKGROUND

• 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. doi: 10.1038/sj.ijir.3901011.

  PMID: 12934056 BACKGROUND

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Lidocaine, Prilocaine Drug Combination; Prilocaine

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Plethora Solutions

mail@plethorasolutions.co.uk

+44 (0) 20 3077 5400

Study Officials

• Culley Carson, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 26, 2016
• Results First Posted: September 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)