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Introduction Premature ejaculation (PE) is the most common male sexual dysfunction affecting men and their partners. Lack of community-based data describing this condition limits understanding of PE and its outcomes. Aim To characterize PE in a large population of men with and without PE using patient-reported outcome (PRO) measures elicited from men and their partners. Methods 4-week, multicenter, observational study of males (≥18 years) and their female partners in monogamous relationships (≥6 months). Screening, baseline, and follow-up visits scheduled at 2-week intervals. Clinicians diagnosed PE utilizing DSM-IV-TR criteria. Intravaginal ejaculatory latency time (IELT), measured by a stopwatch held by the partner, was recorded for each sexual intercourse experience. Subject and partner independently assessed PROs: control over ejaculationand satisfaction with sexual intercourse(0 = very poor to 4 = very good), personal distressand interpersonal difficulty(0 = not at all to 4 = extremely), and severity of PE(0 = none to 3 = severe). Results Of the total study population (N = 1,587), 207 subjects were diagnosed with PE and 1,380 were assigned to the non-PE group. Median IELT (min) was 1.8 (range, 0–41) for PE and 7.3 (range, 0–53) for non-PE subjects (P < 0.0001). More PE vs. non-PE subjects gave ratings of “very poor” or “poor” for control over ejaculation(72% vs. 5%; P < 0.0001) and satisfaction with sexual intercourse(31% vs. 1%; P < 0.0001). More subjects in the PE vs. non-PE group gave ratings of “quite a bit” or “extremely” for personal distress(64% vs. 4%; P < 0.0001) and interpersonal difficulty(31% vs. 1%; P < 0.0001). Subject and partner assessments showed similar patterns and correlated moderately (0.36–0.57). Conclusions PE subjects reported significantly shorter IELT. Overlap in IELT distributions was observed between the PE and non-PE groups, indicating the need for additional PRO measures to characterize PE. Shorter IELT was significantly associated with reduced ejaculatory control and sexual satisfaction and increased distress and interpersonal difficulty.

The February 16, 2001, meeting represented an important step in harmonizing efforts across various organizations and in opening a dialogue with the FDA around major issues related to methodologic standards for measuring and interpreting PROs in the drug evaluation process.

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Published evidence of the content validity of a PRO instrument for an intended application is often limited. Such evidence is, however, important to evaluating the adequacy of a PRO instrument for the intended application. This article provides an overview of key issues involved in assessing and documenting content validity as it relates to using existing instruments in the drug approval process.