Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
NCT ID: NCT01024491
Last Updated: 2009-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
174 participants
INTERVENTIONAL
2008-08-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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paroxetine 15mg
Active treatment with daily dose of paroxetine 15mg.
paroxetine
daily dose of paroxetine 15mg for 12 weeks
paroxetine 20 mg
Active treatment daily dose of paroxetine 20 mg
paroxetine
active daily treatment with paroxetine 20 mg
placebo
placebo
placebo
active daily treatment with placebo
Interventions
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paroxetine
daily dose of paroxetine 15mg for 12 weeks
paroxetine
active daily treatment with paroxetine 20 mg
placebo
active daily treatment with placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
MALE
No
Sponsors
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MorePharma Corporation
INDUSTRY
Responsible Party
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MorePharma Corporation
Principal Investigators
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Eusebio Rubio-Aurioles, M.D, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asociacion Mexicana para la Salud Sexual, A.C.
Locations
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Centro Especializado en Urología y Andrología del Hospital Star Médica
Mexico City, Mexico City, Mexico
Asociacion Mexicana para la Salud Sexual, A.C.
Mexico City, Mexico City, Mexico
Countries
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References
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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.
Other Identifiers
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MPEP-01
Identifier Type: -
Identifier Source: org_study_id