Login to Access Video or Poster Abstract: MP84-07
Sources of Funding: Ixchelsis Ltd.

Introduction

Efficacy Assessments in trials of Premature Ejaculation (PE) include intravaginal ejaculatory latency time (IELT), Clinical Global Impression of Change (CGIC) and the Premature Ejaculation Profile (PEP). The objective of this paper is to systematically compare and correlate the IELT, CGIC and PEP data from a clinical trial recruiting men with lifelong PE.

Methods

Patients in Trial NCT02232425 recorded IELT measured by stopwatch and 2 PEP questions (ejaculation control and ejaculation-related distress) using an e-diary daily during 4 weeks prior to treatment and 8 weeks of study drug treatment. Patients also completed all 4 PEP questions every 4 weeks, and the CGIC at end of treatment. PEP questions on control and distress were scored 0 (worst) to 4 (best response). Treatment groups were analyzed together. IELT, CGIC and PEP results were systematically compared. Descriptive statistics, correlation coefficients (Pearson and Spearman) and Bland-Altman plots were produced for each treatment interval. Box and whisker plots were produced by category of improvement in PEP question scales.

Results

Data collected daily via e-Diary and based on 4-week recall showed equivalent results (Figure 1 shows results for distress). Each endpoint was sensitive to treatment-related change, and all measures showed a high degree of concordance with one another. For example, improvements in IELT correlated with improved control and reduction in ejaculation-related distress (Figure 2). Men with lifelong PE generally perceived improvement in their condition when their IELT increased by approximately 40 seconds or more, or the fold increase in IELT was 2.5 or greater.

Conclusions

The results strongly support the use of these efficacy instruments in PE studies. The combination of objective (IELT) and subjective (PEP, CGIC) measures is necessary and appropriate for assessing treatment benefit in men with PE.

Funding

Ixchelsis Ltd.