The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculat… (NCT01063881) | Clinical Trial Compass
CompletedPhase 3
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Australia, South Korea285 participantsStarted 2010-05-22
Plain-language summary
The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.
Who can participate
Age range18 Years – 99 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be heterosexual males and in a stable monogamous, sexual relationship with a female partner for at least 6 months
* must score =11 in the Premature Ejaculation Diagnostic Tool (PEDT)
* Must have a self-estimated intravaginal ejaculatory latency time (IELT) of = 2 minutes
* Must have an International Index of Erectile Dysfunction (IIEF) score a total of \> or = to 21 in 6 questions from the IIEF used to assess for the absence of moderate to severe erectile dysfunction (ED)
* Premature ejaculation is not exclusively due to the direct effects of a substance (e.g., withdrawal from opioids)
* Must be in good general health with no clinically significant abnormalities as determined by medical history, physical examination, and clinical lab results
* Must have a blood pressure =180 mmHg systolic and =100 mmHg diastolic at screening and at the baseline visit
* Patient's partner must not be pregnant at screening as pregnancy might affect sexual activity
* Participants and partners must agree to attempt sexual intercourse at least 2 times (with a minimum of 24 hours between each event) during the 2-week baseline period and at least 4 times per month during the remainder of the study.
Exclusion Criteria:
* History of or current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder
* History of alcohol abuse and dependence, non-alcohol psychoactive substance use diso…
What they're measuring
1
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment