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Premature EjaculationPhase 3NCT01024491

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

A Phase 3 study testing paroxetine in people with Premature Ejaculation, run by MorePharma Corporation at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 70 years, men only
Conditions the study is for
Premature Ejaculation
What is being tested?
paroxetine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
2 sitesMexico
Study dates
Aug 2008to Apr 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

  • Centro Especializado en Urología y Andrología del Hospital Star Médica

    Mexico City, Mexico City, 06700

  • Asociacion Mexicana para la Salud Sexual, A.C.

    Mexico City, Mexico City, 14000

Other trials in Mexico

About this study

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

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

Read the 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.

Being tested
paroxetine, placebo
Keywords
premature ejaculation, paroxetine, daily treatment
Medical subject headings
Premature Ejaculation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paroxetineDrug

    daily dose of paroxetine 15mg for 12 weeks

  • paroxetineDrug

    active daily treatment with paroxetine 20 mg

  • placeboDrug

    active daily treatment with placebo

Study groups in NCT01024491
Study groupRoleWhat they receive
paroxetine 15mgExperimentalActive treatment with daily dose of paroxetine 15mg.
Receives: Drug: paroxetine
paroxetine 20 mgExperimentalActive treatment daily dose of paroxetine 20 mg
Receives: Drug: paroxetine
placeboExperimentalplacebo
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intravaginal Ejaculatory Latency Time (IELT)

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

Secondary outcomes (5)

  1. Score of the control domain of the Index of Premature Ejaculation

    Measured: 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

  2. Score of the sexual satisfaction domain of the Index of Premature Ejaculation

    Measured: 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

  3. Score of the distress with ejaculation domain of the Index of Premature Ejaculation

    Measured: 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

  4. Erectile function domain of the International Index of Erectile Function

    Measured: 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

  5. Sexual desire domain of the International Index of Erectile Function

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2009 (estimated)
  2. Study startAug 2008
  3. Primary completionMar 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01024491
Sponsor's protocol ID
MPEP-01
Status last verified
Dec 2009
First submitted
30 Nov 2009
Last updated
2 Dec 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16422794

  • 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.

    PubMed 16469562

  • 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.

    PubMed 16205491

  • 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.

    PubMed 14562129

  • 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.

    PubMed 9126089

  • 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.

    PubMed 11386492

  • 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.

    PubMed 16681472

  • 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.

    PubMed 12152111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paroxetine in people with Premature Ejaculation, run by MorePharma Corporation at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01024491, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.

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