Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation

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

Details

• Lead Sponsor: MorePharma Corporation
• Treatments: Paroxetine

Criteria

Inclusion Criteria:

• men between 20 and 70 years of age

• with a stable relationship with a female partner

• with the intention to continue with the same partner for the duration of the study

• with diagnosis of premature ejaculation according to the criteria established in the Diagnostic and Statistical Manual of Mental Disorders IV edition, Revised Text for at least 6 months before inclusion

• with an Intravaginal Ejaculatory Latency Time (IELT) ≤ 3 minutes in at least 75 % of a minimum of three sexual encounters, elapsing between them at least 18 hours during the selection phase of the study

• with agreement to avoid pregnancy or planned surgery during the study,

• female participants should not be pregnant at the inclusion

• both male and female partners had to agree to participate and to sign the informed consent form

Exclusion Criteria:

• any medical or surgical condition that could be associated with the initiation of premature ejaculation for secondary PE

• history of myocardial infarction or stroke in the last 6 months

• hemorrhagic disorder, hepatitis B or C, HIV infection, penile implant surgery at any time

• alcohol or drug abuse in the last 2 years

• any medical or psychiatric condition that could interfere with study procedures and evaluations

• uncontrolled diabetes

• hypotension (defined as systolic/diastolic blood pressure < 90/50 mm Hg)

• uncontrolled hypertension

• diagnosis of erectile dysfunction or a score ≤ 21 in the erectile function domain of the International Index of Erectile Function (IIEF) at inclusion

• treatment with any investigational drug in the last month or 5 times the half life of the drug

• use of medications that could enhance the effect of paroxetine,

• known intolerance to selective serotonin recapture inhibitors

• hypoactive sexual desire not caused by PE

• sexual dysfunction in the female partner that could interfere with participation

• any other significant clinical conditions that could interfere with study procedures

• employees of research sites and relatives of researchers