Erectile DysfunctionNCT00210678
A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation
An observational study of Erectile Dysfunction, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to assess the validity of patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,115 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Sep 2005
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: One thousand patients (at least 200 men with premature ejaculation (PE) and at least 800 men without PE) will be enrolled in the study.
Who may be able to join
- Must be in a stable, monogamous, sexual relationship with the same woman (18 years of age or older) for at least 6 months, who plan to maintain their relationship for the duration of the study
- Must be in good general health
- Patient and partner willing to avoid situations or activities that may have an effect on their sexual activity (eg, refrain from any preplanned surgery)
Who cannot join
- Has history of drug abuse within the past 2 years
- Has history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism
- Must have erectile dysfunction
- Patient who has decreased interest in sexual intercourse or has other forms of sexual dysfunction
- Patient whose partner has decreased interest in sexual intercourse, painful intercourse, or other forms of female sexual dysfunction
- Patient whose partner is more than 3 months pregnant
About this study
Official title: An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation
The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to assess the validity of patient-reported outcomes.
Read the detailed description
This is a multinational, multicenter, observational study in men with and without PE. The study consists of three visits: one visit for screening and enrollment, and two visits for observation after 1 and 2 months (total duration of 8 weeks). No study treatment for PE is administered to patients during the course of the study. Patients and their partners are expected to attempt sexual intercourse at least 2 times a week during the 8-week study period and to use a stopwatch to record the intravaginal ejaculatory latency time (IELT) during intercourse. At visits during the observation period "patients" (and/or partners if partners are responsible for completing questionaires) also provide patient-reported outcomes (PROs) by answering several questionnaires that include the topics of control over ejaculation, satisfaction with sexual intercourse, personal distress, interpersonal difficulty, and self-esteem. The study will estimate the distribution of the average IELT values for men with PE and men without PE.
- Conditions
- Erectile Dysfunction
- Being tested
- No intervention
- Keywords
- Erectile Dysfunction, Dapoxetine, Premature ejaculation, Ejaculation, Sexual dysfunction, Orgasmic disorder
- Medical subject headings
- Erectile Dysfunction, Premature Ejaculation, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionBehavioural
No treatment is given to the patients as this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Group: 1 | Men with premature ejaculation (PE) Receives: Behavioral: No intervention | |
| Group: 2 | Men without PE Receives: Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intravaginal Ejaculatory Latency Time (IELT)
Estimated distribution of the average IELT for both the premature ejaculation (PE) and non-PE populations will be calculated.
Measured: Day 1 to Week 8
Change in Patient-Reported Outcomes (PRO)
Additional evidence of reliability and validity of PROs for patients with and without PE and their partners will be expolred. The PROs will include different parameters related to (control over ejaculation, satisfaction with sexual intercourse, personal distress, and interpersonal difficulty).
Measured: Week 4 and Week 8
Secondary outcomes (3)
Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs)
Association between IELT and PROs used in this study will be explored.
Measured: Up to Week 8
Utility of the Male Sexual Function Scale and Ejaculation Questionnaires
The study will explore utility of the Male Sexual Function Scale and Ejaculation Questionnaire as screening instruments.
Measured: Day 1
PROs and IELT as indicators to clasify PE status.
The study will evaluate the ability of PROs and IELT to classify PE status
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210678
- Sponsor's protocol ID
- CR004225
- Other IDs
- R096769-PRE-3004
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation
- ClinicalTrials.gov ID
- NCT00210678
- Acronym / sponsor ID
- CR004225
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Dapoxetine, Premature ejaculation, Ejaculation, Sexual dysfunction, Orgasmic disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,115 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to assess the validity of patient-reported outcomes.
Detailed description
This is a multinational, multicenter, observational study in men with and without PE. The study consists of three visits: one visit for screening and enrollment, and two visits for observation after 1 and 2 months (total duration of 8 weeks). No study treatment for PE is administered to patients during the course of the study. Patients and their partners are expected to attempt sexual intercourse at least 2 times a week during the 8-week study period and to use a stopwatch to record the intravaginal ejaculatory latency time (IELT) during intercourse. At visits during the observation period "patients" (and/or partners if partners are responsible for completing questionaires) also provide patient-reported outcomes (PROs) by answering several questionnaires that include the topics of control over ejaculation, satisfaction with sexual intercourse, personal distress, interpersonal difficulty, and self-esteem. The study will estimate the distribution of the average IELT values for men with PE and men without PE.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group: 1 | – | Behavioral: No interventionMen with premature ejaculation (PE) |
| Group: 2 | – | Behavioral: No interventionMen without PE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One thousand patients (at least 200 men with premature ejaculation (PE) and at least 800 men without PE) will be enrolled in the study.
Key inclusion criteria (3 listed)
- Must be in a stable, monogamous, sexual relationship with the same woman (18 years of age or older) for at least 6 months, who plan to maintain their relationship for the duration of the study
- Must be in good general health
- Patient and partner willing to avoid situations or activities that may have an effect on their sexual activity (eg, refrain from any preplanned surgery)
Key exclusion criteria (6 listed)
- Has history of drug abuse within the past 2 years
- Has history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism
- Must have erectile dysfunction
- Patient who has decreased interest in sexual intercourse or has other forms of sexual dysfunction
- Patient whose partner has decreased interest in sexual intercourse, painful intercourse, or other forms of female sexual dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo treatment is given to the patients as this is an observational study. | Behavioural | Group: 1, Group: 2 |
Primary outcome
Change in Intravaginal Ejaculatory Latency Time (IELT)
Time frame: Day 1 to Week 8
Estimated distribution of the average IELT for both the premature ejaculation (PE) and non-PE populations will be calculated.
Change in Patient-Reported Outcomes (PRO)
Time frame: Week 4 and Week 8
Additional evidence of reliability and validity of PROs for patients with and without PE and their partners will be expolred. The PROs will include different parameters related to (control over ejaculation, satisfaction with sexual intercourse, personal distress, and interpersonal difficulty).
3 secondary outcomes
Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs)
Time frame: Up to Week 8
Utility of the Male Sexual Function Scale and Ejaculation Questionnaires
Time frame: Day 1
PROs and IELT as indicators to clasify PE status.
Time frame: Up to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 6 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 10 Oct 2012. 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.
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?
Change in Intravaginal Ejaculatory Latency Time (IELT) (time frame: Day 1 to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2012.