search
Back to results

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

Primary Purpose

Premature Ejaculation

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
paroxetine
paroxetine
placebo
Sponsored by
MorePharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring premature ejaculation, paroxetine, daily treatment

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Asociacion Mexicana para la Salud Sexual, A.C.
  • Centro Especializado en Urología y Andrología del Hospital Star Médica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

paroxetine 15mg

paroxetine 20 mg

placebo

Arm Description

Active treatment with daily dose of paroxetine 15mg.

Active treatment daily dose of paroxetine 20 mg

placebo

Outcomes

Primary Outcome Measures

Intravaginal Ejaculatory Latency Time (IELT)

Secondary Outcome Measures

Score of the control domain of the Index of Premature Ejaculation
Score of the sexual satisfaction domain of the Index of Premature Ejaculation
Score of the distress with ejaculation domain of the Index of Premature Ejaculation
Erectile function domain of the International Index of Erectile Function
Sexual desire domain of the International Index of Erectile Function

Full Information

First Posted
November 30, 2009
Last Updated
December 1, 2009
Sponsor
MorePharma Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01024491
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MorePharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
premature ejaculation, paroxetine, daily treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paroxetine 15mg
Arm Type
Experimental
Arm Description
Active treatment with daily dose of paroxetine 15mg.
Arm Title
paroxetine 20 mg
Arm Type
Experimental
Arm Description
Active treatment daily dose of paroxetine 20 mg
Arm Title
placebo
Arm Type
Experimental
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Description
daily dose of paroxetine 15mg for 12 weeks
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Description
active daily treatment with paroxetine 20 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
active daily treatment with placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eusebio Rubio-Aurioles, M.D, Ph.D.
Organizational Affiliation
Asociacion Mexicana para la Salud Sexual, A.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociacion Mexicana para la Salud Sexual, A.C.
City
Mexico City
State/Province
Mexico D.F.
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Centro Especializado en Urología y Andrología del Hospital Star Médica
City
Mexico City
State/Province
Mexico D.F
ZIP/Postal Code
06700
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
16422794
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.
Results Reference
background
PubMed Identifier
16469562
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.
Results Reference
background
PubMed Identifier
16205491
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.
Results Reference
background
Citation
American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed, Text Revision. Washington, DC, American Psychiatric Association, 2000.
Results Reference
background
PubMed Identifier
14562129
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.
Results Reference
background
PubMed Identifier
9126089
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.
Results Reference
background
PubMed Identifier
11386492
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.
Results Reference
background
PubMed Identifier
16681472
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.
Results Reference
background
PubMed Identifier
12152111
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs