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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00211094
Eligibility Criteria:
Inclusion Criteria:
* 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
* history of premature ejaculation in the 6 months before study initiation not due to distress, interpersonal difficulty or medication withdrawal
* history of intravaginal ejaculatory latency time (IELT) of \< = 2 minutes in at least 3 out of 4 events
* blood pressure \< = 180/100 mmHg at screening and end of baseline
* patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
* patient's partner must have a negative urine pregnancy test at time of screening
Exclusion Criteria:
* Not taken dapoxetine in a previous investigational drug study
* not using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
* no history of any medical events that are associated with the development of PE
* not taken another investigational drug within 1 month
* no history of seizures or major psychiatric disorder such as depression or schizophrenia
* no alcohol abuse and dependence
* no known allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors (SSRIs)
* no partners with decreased interest in or painful intercourse or other forms of sexual dysfunction
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00211094
Study Brief:
Protocol Section:
NCT00211094