Premature EjaculationPENCT02844998
The Impact and Benefit of Physical Activity on Premature Ejaculation
A study testing physical activity and dapoxetine 30 mg on demand in people with Premature Ejaculation, run by Ankara Training and Research Hospital.
Trial summary
The purpose of this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- physical activity and dapoxetine 30 mg on demand
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sexually active, heterosexual patients without regular physical activity or erectile dysfunction, and had a sexual partner for at least six months, and sexual intercourse at least twice a week
Who cannot join
- Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases, use of alcohol or addictive substances, or use of drugs that might affect erection and ejaculation, presence of patients with Peyronie's disease, chronic prostatitis, urethritis, or active urinary tract infection, and absence of regular physical activity or previous treatment for premature ejaculation.
About this study
Official title: The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial
The purpose of this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE.
- Conditions
- Premature Ejaculation
- Being tested
- physical activity, dapoxetine 30 mg on demand
- Keywords
- intravaginal ejaculatory latency time, international physical activity questionnaire, premature ejaculation diagnostic tool
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week
dapoxetine 30 mg on demandDrug
Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
| Study group | Role | What they receive |
|---|---|---|
| Dapoxetine 30 mg | Active comparator | Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) Receives: Drug: dapoxetine 30 mg on demand |
| Moderate Running | Experimental | Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (Minimally active category) Receives: Behavioral: physical activity |
| Sham-controlled | Sham comparator | Patients who have sedentary life style will be advised those to walk (not running )at most 30 minutes for 5 days in a week. (Inactive category) Receives: Behavioral: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Ejaculation Diagnostic Tool (Total Score)
Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.
Measured: Baseline and 30 Days
Intravaginal Ejaculatory Latency Time
Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)
Measured: Baseline and 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844998
- Sponsor's protocol ID
- 5191
- Acronym
- PE
- Status last verified
- Sep 2017
- First submitted
- 13 Jul 2016
- Last updated
- 29 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, May K, Abraham L, Crossland A, Morris M. Development and validation of a premature ejaculation diagnostic tool. Eur Urol. 2007 Aug;52(2):565-73. doi: 10.1016/j.eururo.2007.01.028. Epub 2007 Jan 16.
PubMed 17275165Sunay D, Sunay M, Aydogmus Y, Bagbanci S, Arslan H, Karabulut A, Emir L. Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial. Eur Urol. 2011 May;59(5):765-71. doi: 10.1016/j.eururo.2011.01.019. Epub 2011 Jan 18.
PubMed 21256670
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02844998
- Acronym / sponsor ID
- PE / 5191
- Conditions
- Premature Ejaculation
- Keywords
- intravaginal ejaculatory latency time, international physical activity questionnaire, premature ejaculation diagnostic tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Posted 29 Sep 2017
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 this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapoxetine 30 mg | Active comparator | Drug: dapoxetine 30 mg on demandPatients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) |
| Moderate Running | Experimental | Behavioral: physical activityPatients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (Minimally active category) |
| Sham-controlled | Sham comparator | Behavioral: physical activityPatients who have sedentary life style will be advised those to walk (not running )at most 30 minutes for 5 days in a week. (Inactive category) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sexually active, heterosexual patients without regular physical activity or erectile dysfunction, and had a sexual partner for at least six months, and sexual intercourse at least twice a week
Key exclusion criteria (1 listed)
- Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases, use of alcohol or addictive substances, or use of drugs that might affect erection and ejaculation, presence of patients with Peyronie's disease, chronic prostatitis, urethritis, or active urinary tract infection, and absence of regular physical activity or previous treatment for premature ejaculation.
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 |
|---|---|---|
| physical activitypatients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week | Behavioural | Moderate Running, Sham-controlled |
| dapoxetine 30 mg on demandDapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries | Drug | Dapoxetine 30 mg |
Primary outcome
Premature Ejaculation Diagnostic Tool (Total Score)
Time frame: Baseline and 30 Days
Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.
Intravaginal Ejaculatory Latency Time
Time frame: Baseline and 30 Days
Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 17275165Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, May K, Abraham L, Crossland A, Morris M. Development and validation of a premature ejaculation diagnostic tool. Eur Urol. 2007 Aug;52(2):565-73. doi: 10.1016/j.eururo.2007.01.028. Epub 2007 Jan 16.
- Background: PubMed 21256670Sunay D, Sunay M, Aydogmus Y, Bagbanci S, Arslan H, Karabulut A, Emir L. Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial. Eur Urol. 2011 May;59(5):765-71. doi: 10.1016/j.eururo.2011.01.019. Epub 2011 Jan 18.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity and dapoxetine 30 mg on demand in people with Premature Ejaculation, run by Ankara Training and Research Hospital.
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 1 inclusion and 1 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 29 Sep 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Premature Ejaculation Diagnostic Tool (Total Score) (time frame: Baseline and 30 Days). 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?
On the ClinicalTrials.gov record for NCT02844998, 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 29 Sep 2017.