Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation - Full Text View

Purpose

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

Condition	Intervention	Phase
Premature Ejaculation	Drug: paroxetine Drug: placebo	Phase 3

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

Resource links provided by NLM:

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by MorePharma Corporation:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment:	174
Study Start Date:	August 2008
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: paroxetine 15mg Active treatment with daily dose of paroxetine 15mg.	Drug: paroxetine daily dose of paroxetine 15mg for 12 weeks
Experimental: paroxetine 20 mg Active treatment daily dose of paroxetine 20 mg	Drug: paroxetine active daily treatment with paroxetine 20 mg
Experimental: placebo placebo	Drug: placebo active daily treatment with 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.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024491

Locations

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

Sponsors and Collaborators

MorePharma Corporation

Investigators

Principal Investigator:

Eusebio Rubio-Aurioles, M.D, Ph.D.

Asociacion Mexicana para la Salud Sexual, A.C.

More Information

Publications:

McMahon C. Premature ejaculation: past, present, and future perspectives. J Sex Med. 2005 May;2 Suppl 2:94-5. Review. No abstract available.

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

Jannini E,; Lenzi A. Epidemiology of premature ejaculation. Andrology, sexual dysfunction and infertility Current Opinion in Urology. 2005,15(6):399-403.

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.

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.

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.

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.

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.

Responsible Party:	Luz Maria Lopez - Martinez MD, MorePharma Corporation
ClinicalTrials.gov Identifier:	NCT01024491 History of Changes
Other Study ID Numbers:	MPEP-01
Study First Received:	November 30, 2009
Last Updated:	December 1, 2009
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by MorePharma Corporation:

premature ejaculation
paroxetine
daily treatment

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013