Premature EjaculationNCT04841395
Chronotype and Premature Ejaculation
An observational study of Premature Ejaculation, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronotype (or circadian preference) has previously been shown to be associated with sexual attitudes and behaviors and is an important factor affecting sexual satisfaction. The fact that some neurobiological variables, which are thought to have a role in ejaculation physiology, are also effective in the processes of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)
- How many people
- 217 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 30 Dec 2019
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Males who presented at the outpatient clinic of Urology with the self-reported complaint of lifelong premature ejaculation
Who may be able to join
- male between the ages of 18-50 years,
- being sexually active, and in a stable relationship with a single partner for the last 6 months
- meeting diagnostic criteria of Premature ejaculation according to ISSM.
Who cannot join
- having a history of neurological and/or psychiatric disorders, any malignancies, sexual dysfunction other than PE, chronic systemic disease, or if they were taking alpha-blockers, phosphodiesterase type-5 inhibitors, 5-alpha reductase inhibitors, anticholinergics, antipsychotics, or antidepressants.
- presence of obesity (body mass index (BMI)> 30)
- presence of Erectile Dysfunction (IIEF-5 score <22)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16500
About this study
Official title: Morningness Chronotype is Associated With Premature Ejaculation
Chronotype (or circadian preference) has previously been shown to be associated with sexual attitudes and behaviors and is an important factor affecting sexual satisfaction. The fact that some neurobiological variables, which are thought to have a role in ejaculation physiology, are also effective in the processes of sleep and the regulation of circadian rhythm, and evidence supporting the relationship between circadian preferences and sexual desire and sexual behavior; suggests that ejaculation disorders may be related to circadian preference. The aim of the present study was to investigate the relationship between intravaginal ejaculatory latency time (IELT), severity of disease and chronotype in lifelong PE.
Read the detailed description
After being informed about the study, all patients who gave written informed consent were questioned and diagnosed as lifelong PE according to the definition of International Society of sexual medicine (ISSM) by an experienced urologist. Since erctile dysfunction (ED) may accompany PE, the presence of ED symptoms was evaluated by the International Index of Erectile Function (IIEF-5), and those with IIEF-5 score <22 were excluded from the study. Age- and sex-matched control cases without lifelong PE were selected randomly among cases attending the hospital for a checkup procedure. A total of 114 patients with PE and 103 control subjects with similar sociodemographic characteristics were included in the study. A detailed medical and sexual history was taken, which included self-estimated intravaginal ejaculatory latency time (IELT), by an experienced sexual therapist. Moreover, Arabic Index of Premature Ejaculation (AIPE), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.
- Conditions
- Premature Ejaculation
- Being tested
- Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)Diagnostic test
Self-estimated intravaginal ejaculatory latency time IELT is defined as the time between the onset of vaginal intromission and the onset of intravaginal ejaculation. In the present research, self-estimated IELT duration was obtained as a result of interviews with the participants. Moreover, Arabic Index of Premature Ejaculation (AIPE), International Index of Erectile Function (IIEF-5), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.
| Study group | Role | What they receive |
|---|---|---|
| PE | Premature ejaculation group Receives: Diagnostic Test: Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ) | |
| CG | Control group (Healthy subjects) Receives: Diagnostic Test: Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEQ scores
MEQ is a measurement tool developed to measure the morning and evening sleep cycle associated with circadian rhythm (Horne \& Östberg, 1976). It consists of 19 self-reported likert-type items and has a rating range from 16 to 86. Higher scores in the MEQ refer to morningness chronotype, and lower scores refer to eveningness chronotype. In the Turkish adaptation study of MEQ, three different categories of circadian rhythm were defined as; 59-86 points "morningness type", 42-58 points "intermediate type", 16-41 points "eveningness type"
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jun 2019
- Primary completion30 Aug 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sinay Önen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Efe Önen, M.D., Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841395
- Sponsor's protocol ID
- 2011-KAEK-25 2019/04-18
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jankowski KS, Diaz-Morales JF, Randler C. Chronotype, gender, and time for sex. Chronobiol Int. 2014 Oct;31(8):911-6. doi: 10.3109/07420528.2014.925470. Epub 2014 Jun 13.
PubMed 24927370Jocz P, Stolarski M, Jankowski KS. Similarity in Chronotype and Preferred Time for Sex and Its Role in Relationship Quality and Sexual Satisfaction. Front Psychol. 2018 Apr 4;9:443. doi: 10.3389/fpsyg.2018.00443. eCollection 2018.
PubMed 29670559Kasaeian A, Weidenauer C, Hautzinger M, Randler C. Reproductive Success, Relationship Orientation, and Sexual Behavior in Heterosexuals: Relationship With Chronotype, Sleep, and Sex. Evol Psychol. 2019 Jul-Sep;17(3):1474704919859760. doi: 10.1177/1474704919859760.
PubMed 31272215
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morningness Chronotype is Associated With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT04841395
- Acronym / sponsor ID
- 2011-KAEK-25 2019/04-18
- Conditions
- Premature Ejaculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 12 Apr 2021 (actual)
- 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.
Chronotype (or circadian preference) has previously been shown to be associated with sexual attitudes and behaviors and is an important factor affecting sexual satisfaction. The fact that some neurobiological variables, which are thought to have a role in ejaculation physiology, are also effective in the processes of sleep and the regulation of circadian rhythm, and evidence supporting the relationship between circadian preferences and sexual desire and sexual behavior; suggests that ejaculation disorders may be related to circadian preference. The aim of the present study was to investigate the relationship between intravaginal ejaculatory latency time (IELT), severity of disease and chronotype in lifelong PE.
Detailed description
After being informed about the study, all patients who gave written informed consent were questioned and diagnosed as lifelong PE according to the definition of International Society of sexual medicine (ISSM) by an experienced urologist. Since erctile dysfunction (ED) may accompany PE, the presence of ED symptoms was evaluated by the International Index of Erectile Function (IIEF-5), and those with IIEF-5 score <22 were excluded from the study. Age- and sex-matched control cases without lifelong PE were selected randomly among cases attending the hospital for a checkup procedure. A total of 114 patients with PE and 103 control subjects with similar sociodemographic characteristics were included in the study. A detailed medical and sexual history was taken, which included self-estimated intravaginal ejaculatory latency time (IELT), by an experienced sexual therapist. Moreover, Arabic Index of Premature Ejaculation (AIPE), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE | – | Diagnostic Test: Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)Premature ejaculation group |
| CG | – | Diagnostic Test: Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)Control group (Healthy subjects) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males who presented at the outpatient clinic of Urology with the self-reported complaint of lifelong premature ejaculation
Key inclusion criteria (3 listed)
- male between the ages of 18-50 years,
- being sexually active, and in a stable relationship with a single partner for the last 6 months
- meeting diagnostic criteria of Premature ejaculation according to ISSM.
Key exclusion criteria (3 listed)
- having a history of neurological and/or psychiatric disorders, any malignancies, sexual dysfunction other than PE, chronic systemic disease, or if they were taking alpha-blockers, phosphodiesterase type-5 inhibitors, 5-alpha reductase inhibitors, anticholinergics, antipsychotics, or antidepressants.
- presence of obesity (body mass index (BMI)> 30)
- presence of Erectile Dysfunction (IIEF-5 score <22)
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 |
|---|---|---|
| Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)Self-estimated intravaginal ejaculatory latency time IELT is defined as the time between the onset of vaginal intromission and the onset of intravaginal ejaculation. In the present research, self-estimated IELT duration was obtained as a result of interviews with the participants. Moreover, Arabic Index of Premature Ejaculation (AIPE), International Index of Erectile Function (IIEF-5), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants. | Diagnostic test | CG, PE |
Primary outcome
MEQ scores
Time frame: Baseline
MEQ is a measurement tool developed to measure the morning and evening sleep cycle associated with circadian rhythm (Horne \& Östberg, 1976). It consists of 19 self-reported likert-type items and has a rating range from 16 to 86. Higher scores in the MEQ refer to morningness chronotype, and lower scores refer to eveningness chronotype. In the Turkish adaptation study of MEQ, three different categories of circadian rhythm were defined as; 59-86 points "morningness type", 42-58 points "intermediate type", 16-41 points "eveningness type"
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 12 Apr 2021.
- Background: PubMed 24927370Jankowski KS, Diaz-Morales JF, Randler C. Chronotype, gender, and time for sex. Chronobiol Int. 2014 Oct;31(8):911-6. doi: 10.3109/07420528.2014.925470. Epub 2014 Jun 13.
- Background: PubMed 29670559Jocz P, Stolarski M, Jankowski KS. Similarity in Chronotype and Preferred Time for Sex and Its Role in Relationship Quality and Sexual Satisfaction. Front Psychol. 2018 Apr 4;9:443. doi: 10.3389/fpsyg.2018.00443. eCollection 2018.
- Background: PubMed 31272215Kasaeian A, Weidenauer C, Hautzinger M, Randler C. Reproductive Success, Relationship Orientation, and Sexual Behavior in Heterosexuals: Relationship With Chronotype, Sleep, and Sex. Evol Psychol. 2019 Jul-Sep;17(3):1474704919859760. doi: 10.1177/1474704919859760.
- Individual participant dataSharing planned: No
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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.
Efe Önen, M.D. principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ejaculation, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
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?
MEQ scores (time frame: Baseline). 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 NCT04841395, 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 12 Apr 2021.