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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00210678 |
The purpose of the study is to characterize intravaginal ejaculatory latency time in men with and without premature ejaculation and to assess the validity of patient-reported outcomes.
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation |
Estimated Enrollment: | 850 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | September 2005 |
Premature ejaculation (PE) is a form of male sexual dysfunction. In the assessment of PE, an objective measurement is the intravaginal ejaculatory latency time (IELT); subjective measures include ejaculatory control and satisfaction with sexual intercourse. This is a multinational, multicenter, observational study in men with and without PE. The study consists of three visits: one visit for screening and enrollment, and two visits for observation after 1 and 2 months (total duration of 8 weeks). No study treatment for PE is administered to patients during the course of the study. Patients and their partners are expected to attempt sexual intercourse at least 2 times a week during the 8-week study period and to use a stopwatch to record the IELT during intercourse. At visits during the observation period they also provide patient-reported outcomes (PROs) by answering several questionnaires that include the topics of control over ejaculation, satisfaction with sexual intercourse, personal distress, interpersonal difficulty, and self-esteem. The study will estimate the distribution of the average intravaginal ejaculatory latency time values for men with PE and men without PE.
No study treatments are administered.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004225 |
Study First Received: | September 13, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00210678 History of Changes |
Health Authority: | United States: Institutional Review Board |
sexual dysfunction ejaculation premature ejaculation |
orgasmic disorder dapoxetine sexual intercourse |
Sexual Dysfunctions, Psychological Sexual Dysfunction, Physiological Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Sexual Dysfunction, Physiological Mental Disorders |
Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction |