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abstract

abstract

139

Evidence of correlation of PE patient and partner responses to effective therapy

Wyllie, M1; Sharlip, I2

1: GPC Ltd, United Kingdom; 2: UCSF

Objective: Examination of the relationship between patient and partner evaluations in response to Fortacin (PSD502) treatment of subjects with premature ejaculation (PE).

Material and Methods: Analysis of data from 2 phase III, double-blind, placebo-controlled studies on Fortacin in the treatment of the signs and symptoms of PE. Parameters measured were the IELT and the “Control”, “Satisfaction” and “Distress” and “Interpersonal Difficulty “domains of the Premature Ejaculation Profile (PEP) in responses from 539 subjects. Also measured was the Intravaginal Ejaculation latency Time (IELT).

Results: At baseline, the geometric mean IELT was 0.58 in the active group. At month 3 this increased to 3.1mins. The baseline- matched placebo group IELT was 0.86 mins (p<0.001 from Fortacin). Overall, 87% of patients were considered to be responders i.e. no longer were within the ISSM definition of PE. Although responses were measured monthly, all results described here are those captured at the end of the 3-month duration of the study with an average sexual frequency being 5.3 times per month. At this time point all changes in the Fortacin group were statistically different (P<0.001 or greater) from the placebo group. Results described are those registered by patients and partners as “Very Good”, “Good” or “Fair”. With respect to the pateints, themselves, for the Control domain this was 63%. Satisfaction was scored 71%, whereas, Distress and Interpersonal were 71% and 82%, respectively. With respect to partners the equivalent responses were: - Control 71%, Satisfaction, 77%; Distress 80% and Interpersonal Difficulty 87%. In all cases the changes induced by Fortacin treatment of patients resulted in statistically significant in partner responses from baseline and placebo. If data are stratified as “Very good” or “Good” only, a qualitatively similar pattern is still apparent.

Conclusions: As has been described previously, Fortacin produced highly statistically significant improvements in IELT and the domains of the PEP. Most importantly, the present analysis demonstrates that equivalent improvements are recorded by the partners. It is interesting that partner ratings were consistently greater than those recorded by the patients. In addition, it confirms there is a good correlation between increased IELT and the overall sexual experience (at least as captured by the PEP). This type of information is important in setting patient and partner expectations.

Disclosure:

Work supported by industry: yes, by Plethora Solutions (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

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