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

MorePharma

Status and phase: Completed; Phase 3

Conditions: Premature Ejaculation

Treatments: Drug: placebo; Drug: paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024491

MPEP-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 174 patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 3 patient groups

paroxetine 15mg

Experimental group

Description:

Active treatment with daily dose of paroxetine 15mg.

Treatment:

Drug: paroxetine

Drug: paroxetine

paroxetine 20 mg

Experimental group

Description:

Active treatment daily dose of paroxetine 20 mg

Treatment:

Drug: paroxetine

Drug: paroxetine

placebo

Experimental group

Description:

placebo

Treatment:

Drug: placebo