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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: paroxetine 15mg
  • Active treatment with daily dose of paroxetine 15mg.
• Experimental: paroxetine 20 mg
  • Active treatment daily dose of paroxetine 20 mg
• Experimental: placebo
  • placebo

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Score of the control domain of the Index of Premature Ejaculation
  • Time Frame: 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
    Safety Issue?: No
• Score of the sexual satisfaction domain of the Index of Premature Ejaculation
  • Time Frame: 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
    Safety Issue?: No
• Score of the distress with ejaculation domain of the Index of Premature Ejaculation
  • Time Frame: 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
    Safety Issue?: No
• Erectile function domain of the International Index of Erectile Function
  • Time Frame: 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
    Safety Issue?: Yes
• Sexual desire domain of the International Index of Erectile Function
  • Time Frame: 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: MorePharma Corporation Industry

Overall Clinical Trial Officials and Contacts

Eusebio Rubio-Aurioles, M.D, Ph.D. Principal Investigator Asociacion Mexicana para la Salud Sexual, A.C.  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024491

Study ID Number: MPEP-01

ClinicalTrials.gov Identifier: NCT01024491

Health Authority: Mexico: Federal Commission for Protection Against Health Risks