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

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

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation
• Intervention / Treatment: Drug: paroxetine; Drug: paroxetine; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico D.F
    • Mexico City, Mexico D.F, Mexico, 06700
      • Centro Especializado en Urología y Andrología del Hospital Star Médica
  • Mexico D.F.
    • Mexico City, Mexico D.F., Mexico, 14000
      • Asociacion Mexicana para la Salud Sexual, A.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: paroxetine 15mg; Active treatment with daily dose of paroxetine 15mg.	Drug: paroxetine; daily dose of paroxetine 15mg for 12 weeks; Drug: paroxetine; active daily treatment with paroxetine 20 mg
Experimental: paroxetine 20 mg; Active treatment daily dose of paroxetine 20 mg	Drug: paroxetine; daily dose of paroxetine 15mg for 12 weeks; Drug: paroxetine; active daily treatment with paroxetine 20 mg
Experimental: placebo	Drug: placebo; active daily treatment with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intravaginal Ejaculatory Latency Time (IELT)	Visit 2 Baseline, Visit 3 and Visit end of treatment, at 2, 6 and 12 weeks after entry to study respectively

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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
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
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

Collaborators and Investigators

• Sponsor: MorePharma Corporation
• Investigators: Principal Investigator: Eusebio Rubio-Aurioles, M.D, Ph.D., Asociacion Mexicana para la Salud Sexual, A.C.

Publications and helpful links

General Publications

• McMahon C. Premature ejaculation: past, present, and future perspectives. J Sex Med. 2005 May;2 Suppl 2:94-5. doi: 10.1111/j.1743-6109.2005.20368.x. No abstract available.
• Althof SE. Prevalence, characteristics and implications of premature ejaculation/rapid ejaculation. J Urol. 2006 Mar;175(3 Pt 1):842-8. doi: 10.1016/S0022-5347(05)00341-1.
• Jannini EA, Lenzi A. Epidemiology of premature ejaculation. Curr Opin Urol. 2005 Nov;15(6):399-403. doi: 10.1097/01.mou.0000182327.79572.fd.
• American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed, Text Revision. Washington, DC, American Psychiatric Association, 2000.
• Waldinger MD. Towards evidence-based drug treatment research on premature ejaculation: a critical evaluation of methodology. Int J Impot Res. 2003 Oct;15(5):309-13. doi: 10.1038/sj.ijir.3901023.
• Waldinger MD, Hengeveld MW, Zwinderman AH. Ejaculation-retarding properties of paroxetine in patients with primary premature ejaculation: a double-blind, randomized, dose-response study. Br J Urol. 1997 Apr;79(4):592-5. doi: 10.1046/j.1464-410x.1997.00102.x.
• Waldinger MD, Zwinderman AH, Olivier B. Antidepressants and ejaculation: a double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone. J Clin Psychopharmacol. 2001 Jun;21(3):293-7. doi: 10.1097/00004714-200106000-00007.
• Althof S, Rosen R, Symonds T, Mundayat R, May K, Abraham L. Development and validation of a new questionnaire to assess sexual satisfaction, control, and distress associated with premature ejaculation. J Sex Med. 2006 May;3(3):465-75. doi: 10.1111/j.1743-6109.2006.00239.x.
• Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): December 2, 2009
• Last Update Submitted That Met QC Criteria: December 1, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: paroxetine; premature ejaculation; daily treatment
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: MPEP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No