Erectile Dysfunction, CTCAENCT06798350
Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
An observational study of Erectile Dysfunction, CTCAE, run by Xijing Hospital.
Trial summary
Project Title**: Clinical Study on the Role of Inflammatory Markers in Patients with Erectile Dysfunction Research Objective**: To explore the changes in the levels of inflammatory markers in patients with erectile dysfunction (ED), providing scientific evidence for the diagnosis and treatment of ED. 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, CTCAE
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 10 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Inclusion Criteria for Case Group: Males with regular sexual activity; Age between 18 and 55 years; Complete medical records; Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score < 22. Cases with an IIEF-5 score < 22 are diagnosed with ED, while the rest are diagnosed as non-ED. Inclusion Criteria for Control Group: Males with regular sexual activity; Age between 18 and 55 years; matched with the case group by age difference < 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected; Complete medical records; Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.
Who may be able to join
- Males with regular sexual activity; Age between 18 and 55 years; matched with the case group by age difference < 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected; Complete medical records; Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.
Who cannot join
- Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis; Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i); Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections; Patients with poor rapid eye movement (REM) sleep quality.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Project Title**: Clinical Study on the Role of Inflammatory Markers in Patients with Erectile Dysfunction
- Research Objective**:
To explore the changes in the levels of inflammatory markers in patients with erectile dysfunction (ED), providing scientific evidence for the diagnosis and treatment of ED.
Read more
Study Design: Retrospective controlled study
- Total Sample Size**: 150 cases
- Case Selection**:
- Inclusion Criteria for Case Group**:
- Males with regular sexual activity;
- Age between 18 and 55 years;
- Complete medical records;
- Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score < 22. Cases with an IIEF-5 score < 22 are diagnosed with ED, while the rest are diagnosed as non-ED.
- Inclusion Criteria for Control Group**:
- Males with regular sexual activity;
- Age between 18 and 55 years; matched with the case group by age difference < 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected;
- Complete medical records;
- Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.
- Exclusion Criteria**:
- Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis;
- Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i);
- Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections;
- Patients with poor rapid eye movement (REM) sleep quality.
- Efficacy Assessment**:
- Observational Indicators**:
Peripheral blood count, including monocyte count, neutrophil count, lymphocyte count, and biochemical markers such as C-reactive protein.
Safety Evaluation Indicators: Reproductive system damage.
Statistical Methods: Data analysis will be performed using R software (version 4.1.6). All statistical tests will be two-sided, with P values < 0.05 considered significant. Normality of data will be assessed using the Shapiro-Wilk test. Data with normal distribution will be presented as mean ± standard deviation, and data with non-normal distribution will be presented as median [interquartile range]. Baseline characteristics will be compared using independent sample t-tests, Mann-Whitney U tests, or chi-square/Fisher's exact tests. Multivariate analysis will be conducted using logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI). Missing data will be handled using appropriate methods based on the data missing mechanism. To control Type I errors, Bonferroni correction will be applied during multiple comparisons. All analysis procedures and code will be documented in detail to ensure the reproducibility of the analysis.
- Conditions
- Erectile Dysfunction, CTCAE
- Medical subject headings
- Erectile Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnosis of ED
The diagnosis of ED is based on the IIEF-5 questionnaire score, with patients scoring <22 being diagnosed with ED, and the remaining patients being diagnosed as non-ED.
Measured: A retrospective study observing patients approximately 1 month before and after diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start10 Mar 2025 (estimated)
- Primary completion10 Apr 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction, CTCAEStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798350
- Sponsor's protocol ID
- XJLL-KY-20252014
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Role of Inflammatory Markers in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06798350
- Acronym / sponsor ID
- XJLL-KY-20252014
- Conditions
- Erectile Dysfunction, CTCAE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
- Project Title**: Clinical Study on the Role of Inflammatory Markers in Patients with Erectile Dysfunction
- Research Objective**:
To explore the changes in the levels of inflammatory markers in patients with erectile dysfunction (ED), providing scientific evidence for the diagnosis and treatment of ED.
Study Design: Retrospective controlled study
- Total Sample Size**: 150 cases
- Case Selection**:
- Inclusion Criteria for Case Group**:
- Males with regular sexual activity;
- Age between 18 and 55 years;
- Complete medical records;
- Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score < 22. Cases with an IIEF-5 score < 22 are diagnosed with ED, while the rest are diagnosed as non-ED.
- Inclusion Criteria for Control Group**:
- Males with regular sexual activity;
- Age between 18 and 55 years; matched with the case group by age difference < 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected;
- Complete medical records;
- Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.
- Exclusion Criteria**:
- Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis;
- Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i);
- Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections;
- Patients with poor rapid eye movement (REM) sleep quality.
- Efficacy Assessment**:
- Observational Indicators**:
Peripheral blood count, including monocyte count, neutrophil count, lymphocyte count, and biochemical markers such as C-reactive protein.
Safety Evaluation Indicators: Reproductive system damage.
Statistical Methods: Data analysis will be performed using R software (version 4.1.6). All statistical tests will be two-sided, with P values < 0.05 considered significant. Normality of data will be assessed using the Shapiro-Wilk test. Data with normal distribution will be presented as mean ± standard deviation, and data with non-normal distribution will be presented as median [interquartile range]. Baseline characteristics will be compared using independent sample t-tests, Mann-Whitney U tests, or chi-square/Fisher's exact tests. Multivariate analysis will be conducted using logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI). Missing data will be handled using appropriate methods based on the data missing mechanism. To control Type I errors, Bonferroni correction will be applied during multiple comparisons. All analysis procedures and code will be documented in detail to ensure the reproducibility of the analysis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria for Case Group: Males with regular sexual activity; Age between 18 and 55 years; Complete medical records; Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score < 22. Cases with an IIEF-5 score < 22 are diagnosed with ED, while the rest are diagnosed as non-ED. Inclusion Criteria for Control Group: Males with regular sexual activity; Age between 18 and 55 years; matched with the case group by age difference < 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected; Complete medical records; Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.
Key inclusion criteria (1 listed)
- Males with regular sexual activity; Age between 18 and 55 years; matched with the case group by age difference < 3 years. If multiple volunteers meet the criteria, the one closest in age to the case group is selected; Complete medical records; Completion of the International Index of Erectile Function-5 (IIEF-5), with IIEF-5 score ≥ 22.
Key exclusion criteria (1 listed)
- Patients with spinal cord injury, neurological diseases, severe heart disease, or a history of penile fibrosis; Patients undergoing treatment with phosphodiesterase type 5 inhibitors (PDE-5i); Patients diagnosed with hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infections; Patients with poor rapid eye movement (REM) sleep quality.
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
The diagnosis of ED
Time frame: A retrospective study observing patients approximately 1 month before and after diagnosis.
The diagnosis of ED is based on the IIEF-5 questionnaire score, with patients scoring <22 being diagnosed with ED, and the remaining patients being diagnosed as non-ED.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, CTCAE, run by Xijing 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: opening soon, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijun Qin (（+86）15521178680, qinwj@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnosis of ED (time frame: A retrospective study observing patients approximately 1 month before and after diagnosis.). 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 29 Jan 2025.