Premature EjaculationNCT04235192
A Multicenter Case-control Study of Risk Factors for Premature Ejaculation in China's Shaanxi Province
An observational study of Premature Ejaculation, run by Xijing Hospital at 1 site in China.
Trial summary
Through a multicenter case-control study on the risk factors of premature ejaculation in Shaanxi, to find out the related factors of the occurrence and development of premature ejaculation, to provide reference for personalized treatment, in order to improve the quality of sexual life of patients and partners. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- How many people
- 1,340 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2019to 1 Oct 2020
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Patients with premature ejaculation in the outpatient department of the hospital were the case group, while patients without premature ejaculation in the outpatient department were the control group
Who may be able to join
- 1) case group
- 18-64 years old, regular sexual life > 6 months;
- Self-report of premature ejaculation;
- Able to complete questionnaires and scale scores independently. 2) control group
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- 18-64 years old, regular sexual life > 6 months;
- Both partners are satisfied with their sexual life;
- Able to complete questionnaires and scale scores independently.
Who cannot join
- 1) case group
- Those who are unable to have sex due to genital malformation;
- Patients with serious cardiovascular and cerebrovascular diseases;
- Severe mental disorders (history of epilepsy, mania, etc.);
- Have a history of brain trauma;
- People with a long history of substance abuse. 2) control group
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- Patients with a history of mental illness;
- Oral selective serotonin (5-ht) reuptake inhibitors, tricyclic antidepressants, triazolidine antidepressants, tramadol and sedatives
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Fei Wu, master, +86-029-84771794, XJYYLLWYH@163.com
About this study
Through a multicenter case-control study on the risk factors of premature ejaculation in Shaanxi, to find out the related factors of the occurrence and development of premature ejaculation, to provide reference for personalized treatment, in order to improve the quality of sexual life of patients and partners.
- Conditions
- Premature Ejaculation
- Keywords
- risk factor
- Medical subject headings
- Premature Ejaculation
What is being measured
The primary outcome is the main question the study is designed to answer.
IELT
Intra-vaginal Ejaculation Latency Time
Measured: Within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start31 Jul 2019
- Primary completion31 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 1,340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Xi'an No.3 Hospital, Shaanxi Armed Police Corps Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235192
- Sponsor's protocol ID
- 4222018004
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Case-control Study of Risk Factors for Premature Ejaculation in China's Shaanxi Province
- ClinicalTrials.gov ID
- NCT04235192
- Acronym / sponsor ID
- 4222018004
- Conditions
- Premature Ejaculation
- Keywords
- risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,340 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Xi'an No.3 Hospital, Shaanxi Armed Police Corps Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 21 Jan 2020 (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.
Through a multicenter case-control study on the risk factors of premature ejaculation in Shaanxi, to find out the related factors of the occurrence and development of premature ejaculation, to provide reference for personalized treatment, in order to improve the quality of sexual life of patients and partners.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with premature ejaculation in the outpatient department of the hospital were the case group, while patients without premature ejaculation in the outpatient department were the control group
Key inclusion criteria (8 listed)
- 1) case group
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Key exclusion criteria (9 listed)
- 1) case group
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IELT
Time frame: Within 6 months
Intra-vaginal Ejaculation Latency Time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
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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.
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 Xijing Hospital at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 21 Jan 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianlin Yuan, doctor (+86-136-0912-3155, jianliny@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IELT (time frame: Within 6 months). 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 21 Jan 2020.