The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pte Ltd

Criteria

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 disorder (except for caffeine or nicotine/tobacco)

• Suspected history of illicit or recreational drug use

• Known history of moderate to severe renal impairment