Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT00210704
Eligibility Criteria:
Inclusion Criteria:
* Male citizens of Asian countries and Australia are encouraged to enroll in the study
* patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
* diagnosis of premature ejaculation (PE) according to the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for at least 6 months before study initiation
* history of intravaginal ejaculatory latency time (IELT) of \<2 minutes in at least 3 out of 4 events
* patient's partner must have a negative urine pregnancy test at time of screening
* Exclusion Criteria:
* Not taken dapoxetine or participated in another study investigating pharmacologic treatment of PE within the last 3 months
* no history of any medical events that are associated with the development of PE
* not taken another investigational drug within 1 month, or used an experimental medical device within 6 months of study initiation
* no positive diagnosis of depressive or anxiety disorder, manic episode, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, schizophrenia, or other psychotic disorders
* no known allergy or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00210704
Study Brief:
Protocol Section:
NCT00210704