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

Premature Ejaculation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024491
• Other study ID #: MPEP-01
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2009
• Last updated: December 1, 2009
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2009
• Source: MorePharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• paroxetine
daily dose of paroxetine 15mg for 12 weeks
• paroxetine
active daily treatment with paroxetine 20 mg
• placebo
active daily treatment with placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MorePharma Corporation

Country where clinical trial is conducted

Mexico, 

References & Publications (9)

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. — View Citation

Althof SE. Prevalence, characteristics and implications of premature ejaculation/rapid ejaculation. J Urol. 2006 Mar;175(3 Pt 1):842-8. Review. — View Citation

American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed, Text Revision. Washington, DC, American Psychiatric Association, 2000.

Jannini EA, Lenzi A. Epidemiology of premature ejaculation. Curr Opin Urol. 2005 Nov;15(6):399-403. Review. — View Citation

McMahon C. Premature ejaculation: past, present, and future perspectives. J Sex Med. 2005 May;2 Suppl 2:94-5. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes