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

MorePharma Corporation2 sites in 1 country174 target enrollmentAugust 2008

ConditionsPremature Ejaculation

Interventionsparoxetine placebo

Drugsparoxetine placebo

Overview

Phase: Phase 3
Intervention: paroxetine
Conditions: Premature Ejaculation
Sponsor: MorePharma Corporation
Enrollment: 174
Locations: 2
Primary Endpoint: Intravaginal Ejaculatory Latency Time (IELT)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

April 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

MorePharma Corporation

Eligibility 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

Arms & Interventions

paroxetine 15mg

Active treatment with daily dose of paroxetine 15mg.

Intervention: paroxetine

paroxetine 20 mg

Active treatment daily dose of paroxetine 20 mg

Intervention: paroxetine

placebo

Intervention: placebo

Outcomes

Primary Outcomes

Intravaginal Ejaculatory Latency Time (IELT)

Time Frame: Visit 2 Baseline, Visit 3 and Visit end of treatment, at 2, 6 and 12 weeks after entry to study respectively

Secondary Outcomes

Score of the control domain of the Index of Premature Ejaculation(Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
Score of the distress with ejaculation domain of the Index of Premature Ejaculation(Visit 1 Screning, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
Score of the sexual satisfaction domain of the Index of Premature Ejaculation(Visit 1 Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
Erectile function domain of the International Index of Erectile Function(Visit 1 Screening, Visit 2 Baseline, Visit 3 and Viit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
Sexual desire domain of the International Index of Erectile Function(Visit 1 Screening,Visit 2 Baseline,Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)