Trial | NCT01024491  Report issue

Title

Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
A Parallel Randomized Double Blind Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    paroxetine ...

  • Study Participants

    174
As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation
Randomized, double blind, placebo controlled, prospective and parallel trial. Men with premature ejaculation using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for at least 6 months, with an intravaginal ejaculatory latency time (IELT) ≤ 3 minutes. Three treatments are to be compared: placebo, 15 mg or 20 mg paroxetine for 12 weeks.
Study Started
Aug 31
2008
Primary Completion
Mar 31
2009
Study Completion
Apr 30
2009
Last Update
Dec 02
2009
Estimate

Drug paroxetine

daily dose of paroxetine 15mg for 12 weeks

Drug paroxetine

active daily treatment with paroxetine 20 mg

Drug placebo

active daily treatment with placebo

paroxetine 15mg Experimental

Active treatment with daily dose of paroxetine 15mg.

paroxetine 20 mg Experimental

Active treatment daily dose of paroxetine 20 mg

placebo Experimental

placebo

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
No Results Posted