A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation

Johnson & Johnson (J&J)

Status

Completed

Conditions

Erectile Dysfunction

Treatments

Behavioral: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT00210678

CR004225

R096769-PRE-3004 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to assess the validity of patient-reported outcomes.

Full description

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 intravaginal ejaculatory latency time (IELT) during intercourse. At visits during the observation period "patients" (and/or partners if partners are responsible for completing questionaires) 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 IELT values for men with PE and men without PE.

Enrollment

1,115 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must be in a stable, monogamous, sexual relationship with the same woman (18 years of age or older) for at least 6 months, who plan to maintain their relationship for the duration of the study
Must be in good general health
Patient and partner willing to avoid situations or activities that may have an effect on their sexual activity (eg, refrain from any preplanned surgery)

Exclusion criteria

Has history of drug abuse within the past 2 years
Has history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism
Must have erectile dysfunction
Patient who has decreased interest in sexual intercourse or has other forms of sexual dysfunction
Patient whose partner has decreased interest in sexual intercourse, painful intercourse, or other forms of female sexual dysfunction
Patient whose partner is more than 3 months pregnant