Erectile DysfunctionPhase 4NCT05446493
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
A Phase 4 study testing Tadalafil 5mg in people with Erectile Dysfunction and Erectile Dysfunction With Diabetes Mellitus, run by Aswan University at 1 site in Egypt.
Trial summary
The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Erectile Dysfunction With Diabetes Mellitus
- What is being tested?
- Tadalafil 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 5 Jan 2022
- Phase
- Phase 4
- 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 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetic patients with ED.
Who cannot join
- Patients with history of pelvic trauma.
- Patients with major pelvic surgical intervention.
- Patients with hypogonadism and hyperprolactinemia.
- Patients with chronic liver disease.
- Patients with cardio vascular system diseases.
- History of chronic intake of central nervous system, anti androgen drugs or other drugs as Tramadol.
- Smokers patients.
- Patients with non-vasculogenic Erectile dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.
- Being tested
- Tadalafil 5mg
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
- Estimate serum level of serum YKL-40, total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3months.
- Penile color Doppler ultrasound examination before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil group | Active comparator | Each patient will be treated by tadalafil 5mg daily for 3months Receives: Drug: Tadalafil 5mg |
| control group | No intervention | Estimation of serum YKL-40, platelet indices and serum total testosterone in healthy individuals in camparing with tadalafil group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum YKL-40 and platelets indices in erectile dysfunction
Measurement of YKL-40 and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil.
Measured: 3 months
Secondary outcomes (1)
Effect of tadalafil on Erectile dysfucntion patients
To show the therapeutic effect of tadalafil in dose 5 mg daily on Erectile dysfucntion patients and assess their response by international index of erectile function (IIEF-5)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Apr 2019
- Primary completion15 Mar 2021
- Study completion5 Jan 2022
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Amer Ahmed Abdellatif, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446493
- Sponsor's protocol ID
- 346/3/19
- Status last verified
- Jul 2022
- First submitted
- 5 Jan 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05446493
- Acronym / sponsor ID
- 346/3/19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 6 Jul 2022 (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.
The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil group | Active comparator | Drug: Tadalafil 5mgEach patient will be treated by tadalafil 5mg daily for 3months |
| control group | No intervention | –Estimation of serum YKL-40, platelet indices and serum total testosterone in healthy individuals in camparing with tadalafil group |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with ED.
Key exclusion criteria (8 listed)
- Patients with history of pelvic trauma.
- Patients with major pelvic surgical intervention.
- Patients with hypogonadism and hyperprolactinemia.
- Patients with chronic liver disease.
- Patients with cardio vascular system diseases.
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 |
|---|---|---|
| Tadalafil 5mg* Estimate serum level of serum YKL-40, total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3months. * Penile color Doppler ultrasound examination before and after treatment | Drug | Tadalafil group |
Primary outcome
Serum YKL-40 and platelets indices in erectile dysfunction
Time frame: 3 months
Measurement of YKL-40 and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil.
1 secondary outcome
Effect of tadalafil on Erectile dysfucntion patients
Time frame: 3 months
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 6 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil 5mg in people with Erectile Dysfunction and Erectile Dysfunction With Diabetes Mellitus, run by Aswan University at 1 site in Egypt.
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 8 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 6 Jul 2022. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum YKL-40 and platelets indices in erectile dysfunction (time frame: 3 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 6 Jul 2022.