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Erectile DysfunctionPhase 3NCT00210704

A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

A Phase 3 study testing Dapoxetine in people with Erectile Dysfunction, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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

The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Dapoxetine
How many people
1,067 participants
Where
No sites listed yet
Study dates
Mar 2005to Jun 2006
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male citizens of Asian countries and Australia are encouraged to enroll in the study
  • patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
  • diagnosis of premature ejaculation (PE) according to the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for at least 6 months before study initiation
  • history of intravaginal ejaculatory latency time (IELT) of <2 minutes in at least 3 out of 4 events
  • patient's partner must have a negative urine pregnancy test at time of screening

Who cannot join

  • Not taken dapoxetine or participated in another study investigating pharmacologic treatment of PE within the last 3 months
  • no history of any medical events that are associated with the development of PE
  • not taken another investigational drug within 1 month, or used an experimental medical device within 6 months of study initiation
  • no positive diagnosis of depressive or anxiety disorder, manic episode, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, schizophrenia, or other psychotic disorders
  • no known allergy or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).

Read the detailed description

Premature ejaculation (PE) is a form of male sexual dysfunction. An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT). This is a multicenter, placebo-controlled, double-blind, randomized, parallel-group study in men with PE. The study will consist 2 phases: pre-randomization phase (a screening visit and a 4-week baseline period); 12-week double-blind treatment phase during which patients will receive dapoxetine or placebo for use on an "as-needed" basis, with a post-study telephone contact approximately 2 weeks after the end of treatment. The total duration of the study is approximately 18 weeks. Assessments of effectiveness include the average intravaginal ejaculatory latency time (as measured by stopwatch) during sexual intercourse, during the treatment period; control over ejaculation, satisfaction with sexual intercourse, and severity of symptoms, based on questions asked at monthly intervals through the treatment phase. Safety assessments include the incidence, severity, and type of adverse events during the study, as well as laboratory tests and questionnaires to monitor sexual function at specified times during the study. The study hypothesis is that treatment for 12 weeks with dapoxetine prolongs intravaginal ejaculatory latency time, compared with placebo, in men with PE. Oral tablets of dapoxetine (30 milligrams[mg] or 60mg) or placebo taken as needed during 12 weeks of treatment. No more than 1 dose within a 24-hour period.

Being tested
Dapoxetine
Keywords
dapoxetine, premature ejaculation, ejaculation, sexual dysfunction, orgasmic disorder, sexual intercourse
Medical subject headings
Erectile Dysfunction, Premature Ejaculation, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Coitus

What participants receive

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

  • DapoxetineDrug

What is being measured

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

  1. Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12)

Secondary outcomes (1)

  1. Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at monthly intervals through Week 12; incidence, severity, and type of adverse events throughout study and follow up (Week 14).

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Study completionJun 2006

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
Double blind
Enrolment
1,067 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00210704
Sponsor's protocol ID
CR004228
Status last verified
Mar 2010
First submitted
13 Sep 2005
Last updated
8 Jun 2011
Results posted
No

Publications

  • McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.

    PubMed 21059176

  • Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. J Sex Med. 2010 Jun;7(6):2231-2242. doi: 10.1111/j.1743-6109.2010.01820.x. Epub 2010 Apr 19.

    PubMed 20412423

  • McMahon C, Kim SW, Park NC, Chang CP, Rivas D, Tesfaye F, Rothman M, Aquilina J; Dapoxetine 3003 Study Investigators. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. J Sex Med. 2010 Jan;7(1 Pt 1):256-68. doi: 10.1111/j.1743-6109.2009.01560.x. Epub 2009 Oct 29.

    PubMed 19878447

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapoxetine in people with Erectile Dysfunction, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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 5 inclusion and 5 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12). 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 NCT00210704, which also lists 3 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 8 Jun 2011.

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