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

NCT01024491 | Completed Phase 3

• 1 other identifier: MPEP-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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

Conditions

Premature Ejaculation

Keywords

premature ejaculation; paroxetine; daily treatment

Outcome Measures

Primary Outcomes (1)

• Intravaginal Ejaculatory Latency Time (IELT)

  Visit 2 Baseline, Visit 3 and Visit end of treatment, at 2, 6 and 12 weeks after entry to study respectively

Secondary Outcomes (5)

• Score of the control domain of the Index of Premature Ejaculation

  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

• Score of the sexual satisfaction domain of the Index of Premature Ejaculation

  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

• Score of the distress with ejaculation domain of the Index of Premature Ejaculation

  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

• Erectile function domain of the International Index of Erectile Function

  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

• Sexual desire domain of the International Index of Erectile Function

  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

Study Arms (3)

paroxetine 15mg

EXPERIMENTAL

Active treatment with daily dose of paroxetine 15mg.

Drug: paroxetine

paroxetine 20 mg

EXPERIMENTAL

Active treatment daily dose of paroxetine 20 mg

Drug: paroxetine

placebo

EXPERIMENTAL

placebo

Drug: placebo

Interventions

paroxetine DRUG

daily dose of paroxetine 15mg for 12 weeks

paroxetine 15mg

placebo DRUG

active daily treatment with placebo

placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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,
• both male and female partners had to agree to participate and to sign the informed consent form

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• MorePharma Corporation: lead

Study Sites (2)

Centro Especializado en Urología y Andrología del Hospital Star Médica

Mexico City, Mexico City, 06700, Mexico

Location

Asociacion Mexicana para la Salud Sexual, A.C.

Mexico City, Mexico City, 14000, Mexico

Location

Related Publications (9)

• 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.

  PMID: 16422794 BACKGROUND

• 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.

  PMID: 16469562 BACKGROUND

• 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.

  PMID: 16205491 BACKGROUND

• American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed, Text Revision. Washington, DC, American Psychiatric Association, 2000.

  BACKGROUND

• 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.

  PMID: 14562129 BACKGROUND

• 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.

  PMID: 9126089 BACKGROUND

• 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.

  PMID: 11386492 BACKGROUND

• 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.

  PMID: 16681472 BACKGROUND

• 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.

  PMID: 12152111 BACKGROUND

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eusebio Rubio-Aurioles, M.D, Ph.D.

  Asociacion Mexicana para la Salud Sexual, A.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 2, 2009

Record last verified: 2009-12

Locations

ME (2)