Erectile DysfunctionNCT03918993
Effects of Tadalafil on LMR and MHR in Patients With ED
An observational study of Erectile Dysfunction and Inflammation, run by Samsun Liv Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED). Read more about this study
- Who is it for?
- Ages 39 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Inflammation
- What is being tested?
- Tadalafil 5mg tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2019to 5 Apr 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 39 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group Thirty-one male patients with organic erectile dysfunction more than one year between 39 and 65 years of age which were treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group
Who may be able to join
- 39-65 years old men with ED
- 39-65 years old, haelthy men
- Patients that have received 5 mg tadalafil/day for 8 weeks
- Patients with informed consent forms
- Patients with no missing variables
Who cannot join
- Patients with systemic autoimmune and inflammatory disease,
- congestive heart failure,
- chronic renal failure, and chronic hepatobiliary disease,
- chronic lung disease, and thyroid dysfunction,
- patients with acute infection,
- patients with neurological deficits,
Show all 10Show fewer
- metabolic syndrome and malignancy
- Patients with a history of prostate, penile or pelvic surgery or radiotherapy,,
- patients receiving anticoagulant, beta-blocker, antidepressants and antipsychotics, hormonal therapy,
- patients with alcohol and smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of a Daily Dose of 5 mg of Tadalafil on Lymphocyte to Monocyte Ratio and Monocyte to High-Density Lipoprotein Ratio in Patients With Erectile Dysfunction
The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED).
Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November 2018 were included in this retrospective study. To avoid bias, the patients were randomly selected and the controls were also incorporated consecutively. The presence of ED was determined according to the International Erectile Function Index-5 (IIEF-5). The patients and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry, LMR, and MHR.
Read the detailed description
The medical records of the heterosexual men treated with the diagnosis of organic ED in the Urology department of a private hospital between July 2017 and October 2018 were evaluated retrospectively. The number of samples to be included in the study was determined by the help of the computer-assisted power analysis. Random sampling was performed from all cohorts of patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group (group T)The patients in group T have been assessed both before (T1) and after (T2) the treatment.
Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group (group C) was formed. All subjects in the control group were sexually active men with regular monogamous heterosexual relationships during the last one year.
.
- Conditions
- Erectile Dysfunction, Inflammation
- Being tested
- Tadalafil 5mg tablet
- Keywords
- Erectile Dysfunction, lymphocyte to monocyte ratio, monocyte to HDL ratio
- Medical subject headings
- Erectile Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mg tabletDrug
Also called phosphodiesterase type 5 (PDE5) inhibitor
Once-a-day 5 mg dose of tadalafil for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group T | 31 Patients with ED who receiving 5 mg/day of Tadalafil for 8 weeks. Receives: Drug: Tadalafil 5mg tablet | |
| Group C | Thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte to Monocyte Ratio
ratio of values in complete blood count
Measured: up to 8 weeks
monocyte to HDL ratio
an inflamamtoy marker
Measured: up to 8 weeks
The International Index of Erectile Function (IIEF-5) Questionnaire
IIEF-5 scoring:
The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunctio
Measured: up to 8 weeks
monocyte count
complete blood count
Measured: up to 8 weeks
lymphocyte count
complete blood count
Measured: up to 8 weeks
HDL cholesterol
serum lipid profile
Measured: up to 8 weeks
Testosteron
hormonal evaluation
Measured: up to 8 weeks
fasting glucose
serum glucose level
Measured: at the 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start14 Feb 2019
- Primary completion10 Mar 2019
- Study completion5 Apr 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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Liv Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Mehmet Necmettin Mercimek, Samsun Liv Hospital
- Investigators
- Yakup Bostancı, MD, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918993
- Sponsor's protocol ID
- OMU KAEK 2019/158
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta BP, Murad MH, Clifton MM, Prokop L, Nehra A, Kopecky SL. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2011 Nov 14;171(20):1797-803. doi: 10.1001/archinternmed.2011.440. Epub 2011 Sep 12.
PubMed 21911624Kadihasanoglu M, Karabay E, Yucetas U, Erkan E, Ozbek E. Relation between Monocyte to High-Density Lipoprotein Cholesterol Ratio and Presence and Severity of Erectile Dysfunction. Aktuelle Urol. 2018 Jun;49(3):256-261. doi: 10.1055/s-0042-123163. Epub 2017 Nov 16.
PubMed 29145685Cimen S, Dursun M, Sulukaya M, Besiroglu H. Could the monocyte/HDL cholesterol ratio be an early marker of erectile dysfunction? Aging Male. 2020 Dec;23(5):694-699. doi: 10.1080/13685538.2019.1574735. Epub 2019 Feb 19.
PubMed 30777468
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of a Daily Dose of 5 mg of Tadalafil on Lymphocyte to Monocyte Ratio and Monocyte to High-Density Lipoprotein Ratio in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03918993
- Acronym / sponsor ID
- OMU KAEK 2019/158
- Conditions
- Erectile Dysfunction, Inflammation
- Keywords
- Erectile Dysfunction, lymphocyte to monocyte ratio, monocyte to HDL ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Samsun Liv HospitalUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 18 Apr 2019 (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 the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED).
Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November 2018 were included in this retrospective study. To avoid bias, the patients were randomly selected and the controls were also incorporated consecutively. The presence of ED was determined according to the International Erectile Function Index-5 (IIEF-5). The patients and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry, LMR, and MHR.
Detailed description
The medical records of the heterosexual men treated with the diagnosis of organic ED in the Urology department of a private hospital between July 2017 and October 2018 were evaluated retrospectively. The number of samples to be included in the study was determined by the help of the computer-assisted power analysis. Random sampling was performed from all cohorts of patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group (group T)The patients in group T have been assessed both before (T1) and after (T2) the treatment.
Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group (group C) was formed. All subjects in the control group were sexually active men with regular monogamous heterosexual relationships during the last one year.
.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T | – | Drug: Tadalafil 5mg tablet31 Patients with ED who receiving 5 mg/day of Tadalafil for 8 weeks. |
| Group C | – | –Thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up |
Who may qualify
- Ages
- 39 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group Thirty-one male patients with organic erectile dysfunction more than one year between 39 and 65 years of age which were treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group
Key inclusion criteria (5 listed)
- 39-65 years old men with ED
- 39-65 years old, haelthy men
- Patients that have received 5 mg tadalafil/day for 8 weeks
- Patients with informed consent forms
- Patients with no missing variables
Key exclusion criteria (10 listed)
- Patients with systemic autoimmune and inflammatory disease,
- congestive heart failure,
- chronic renal failure, and chronic hepatobiliary disease,
- chronic lung disease, and thyroid dysfunction,
- patients with acute infection,
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 tabletAlso: phosphodiesterase type 5 (PDE5) inhibitorOnce-a-day 5 mg dose of tadalafil for 8 weeks | Drug | Group T |
Primary outcome
Lymphocyte to Monocyte Ratio
Time frame: up to 8 weeks
ratio of values in complete blood count
monocyte to HDL ratio
Time frame: up to 8 weeks
an inflamamtoy marker
The International Index of Erectile Function (IIEF-5) Questionnaire
Time frame: up to 8 weeks
IIEF-5 scoring: The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunctio
monocyte count
Time frame: up to 8 weeks
complete blood count
lymphocyte count
Time frame: up to 8 weeks
complete blood count
HDL cholesterol
Time frame: up to 8 weeks
serum lipid profile
Testosteron
Time frame: up to 8 weeks
hormonal evaluation
fasting glucose
Time frame: at the 1st day
serum glucose level
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 23 Apr 2019.
- Results publication: PubMed 21911624Gupta BP, Murad MH, Clifton MM, Prokop L, Nehra A, Kopecky SL. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2011 Nov 14;171(20):1797-803. doi: 10.1001/archinternmed.2011.440. Epub 2011 Sep 12.
- Results publication: PubMed 29145685Kadihasanoglu M, Karabay E, Yucetas U, Erkan E, Ozbek E. Relation between Monocyte to High-Density Lipoprotein Cholesterol Ratio and Presence and Severity of Erectile Dysfunction. Aktuelle Urol. 2018 Jun;49(3):256-261. doi: 10.1055/s-0042-123163. Epub 2017 Nov 16.
- Results publication: PubMed 30777468Cimen S, Dursun M, Sulukaya M, Besiroglu H. Could the monocyte/HDL cholesterol ratio be an early marker of erectile dysfunction? Aging Male. 2020 Dec;23(5):694-699. doi: 10.1080/13685538.2019.1574735. Epub 2019 Feb 19.
- 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.
Yakup Bostancı, MD study chair
Ondokuz Mayıs University
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 Erectile Dysfunction and Inflammation, run by Samsun Liv 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 5 inclusion and 10 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 23 Apr 2019. 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?
Lymphocyte to Monocyte Ratio (time frame: up to 8 weeks). The study lists 8 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 NCT03918993, 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 23 Apr 2019.