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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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,
Sponsor: Plethora Solutions Ltd

Current Primary Outcome:

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

    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).

  • Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 [ Time Frame: Baseline to 3 Months ]

    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



Original 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 selected IPE domains from baseline to month 3 [ Time Frame: 3 Months ]

Current Secondary Outcome:

  • Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment [ Time Frame: 3 months ]
    Percentage of subjects with mean IELT > 1 minute and >2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects
  • Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3 [ Time Frame: 3 months ]
    Summary of mean IELT at Baseline and at month 3 during double-blind treatment
  • Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1 [ Time Frame: 1 month ]

    Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1.

    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

  • Subject PEP at Month 1 [ Time Frame: 1 month ]
    Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1.
  • Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2 [ Time Frame: 2 months ]

    Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2

    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

  • Subject Premature Ejaculation Profile (PEP) at Month 2 [ Time Frame: 2 months ]
    Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2.
  • Subject Premature Ejaculation Profile (PEP) at Month 3 [ Time Frame: 3 months ]
    Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3.
  • Partner Premature Ejaculation Profile (PEP) at Month 3 [ Time Frame: 3 months ]
    Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3.


Original Secondary Outcome: 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 ]

Information By: Plethora Solutions Ltd

Dates:
Date Received: November 9, 2007
Date Started: October 2007
Date Completion:
Last Updated: September 7, 2016
Last Verified: September 2016