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

This study has been completed.
Sponsor:
Information provided by:
MorePharma Corporation
ClinicalTrials.gov Identifier:
NCT01024491
First received: November 30, 2009
Last updated: December 1, 2009
Last verified: December 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Premature Ejaculation
Sexual Dysfunction, Physiological
Genital Diseases, Male
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 September 30, 2014