Clinical trial NCT01024491: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premature Ejaculation
Keywords: premature ejaculation
paroxetine
daily treatment
Lead sponsor: MorePharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 174
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Intravaginal Ejaculatory Latency Time (IELT)
timeFrame: Visit 2 Baseline, Visit 3 and Visit end of treatment, at 2, 6 and 12 weeks after entry to study respectively
Secondary outcomes:
measure: Score of the control domain of the Index of Premature Ejaculation
timeFrame: 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
measure: Score of the sexual satisfaction domain of the Index of Premature Ejaculation
timeFrame: 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
measure: Score of the distress with ejaculation domain of the Index of Premature Ejaculation
timeFrame: 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
measure: Erectile function domain of the International Index of Erectile Function
timeFrame: 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
measure: Sexual desire domain of the International Index of Erectile Function
timeFrame: 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
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociacion Mexicana para la Salud Sexual, A.C.
state: Mexico D.F.
city: Mexico City
country: Mexico
facility: Centro Especializado en Urología y Andrología del Hospital Star Médica
state: Mexico D.F
Study officials:
affiliation: Asociacion Mexicana para la Salud Sexual, A.C.
name: Eusebio Rubio-Aurioles, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed, Text Revision. Washington, DC, American Psychiatric Association, 2000.
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. doi: 10.1038/sj.ijir.3901023.
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. doi: 10.1046/j.1464-410x.1997.00102.x.
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. doi: 10.1097/00004714-200106000-00007.
citation: 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.
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. doi: 10.1038/sj.ijir.3900857.